Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women (H4HW)
28 marca 2022 zaktualizowane przez: Susana Cristina Araújo Póvoas, University Institute of Maia
Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women
This study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport.
The investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. Moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
80
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Porto
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Maia, Porto, Portugalia, 4476-690
- University of Maia
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
Inclusion Criteria:
- Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years
Exclusion Criteria:
- Any medical contraindications to perform moderate-to-vigorous physical activity
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Team handball group
The team handball group participants were encouraged to performed at least two out of three weekly supervised team handball training sessions of 60 min each, for 36 weeks.
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Two to three weekly sessions of recreational team handball training for 36 weeks.
Each 60-min session started with a standardised warm-up (including running, coordination, strength, flexibility, and balance exercises) followed by three 15-min periods of recreational team handball matches, interspersed by 2-min breaks, played as small-sided games (4v4, 5v5 or 6v6).
The training sessions were performed on an indoor team handball court (40x20 m) adjusted to result in 34-36 m2 per player.
During the matches, the participants rotated positions every 3 min in a random order, including the goalkeeper and no exclusions or substitutions were applied.
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Brak interwencji: Control group
The control group participants were instructed to keep their regular daily physical activity for 36 weeks.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Between group differences in peak oxygen uptake at week 16
Ramy czasowe: Week 16
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Week 16
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Between group differences in peak oxygen uptake at week 36
Ramy czasowe: Week 36
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Week 36
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Changes from baseline in peak oxygen uptake at week 16
Ramy czasowe: Baseline and week 16
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Baseline and week 16
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Changes from baseline in peak oxygen uptake at week 36
Ramy czasowe: Baseline and week 36
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Baseline and week 36
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Changes from week 16 in peak oxygen uptake at week 36
Ramy czasowe: Week 16 and week 36
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Week 16 and week 36
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Between group differences in resting heart rate at week 16
Ramy czasowe: Week 16
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Week 16
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Between group differences in resting heart rate at week 36
Ramy czasowe: Week 36
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Week 36
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Changes from baseline in resting heart rate at week 16
Ramy czasowe: Baseline and week 16
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Baseline and week 16
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Changes from baseline in resting heart rate at week 36
Ramy czasowe: Baseline and week 36
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Baseline and week 36
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Changes from week 16 in resting heart rate at week 36
Ramy czasowe: Week 16 and week 36
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Week 16 and week 36
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Between group differences in body mass at week 16
Ramy czasowe: Week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16
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Between group differences in body mass at week 36
Ramy czasowe: Week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 36
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Changes from baseline in body mass at week 16
Ramy czasowe: Baseline and week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 16
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Changes from baseline in body mass at week 36
Ramy czasowe: Baseline and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 36
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Changes from week 16 in body mass at week 36
Ramy czasowe: Week 16 and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16 and week 36
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Between group differences in fat mass at week 16
Ramy czasowe: Week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16
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Between group differences in fat mass at week 36
Ramy czasowe: Week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 36
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Changes from baseline in fat mass at week 16
Ramy czasowe: Baseline and week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 16
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Changes from baseline in fat mass at week 36
Ramy czasowe: Baseline and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 36
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Changes from week 16 in fat mass at week 36
Ramy czasowe: Week 16 and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16 and week 36
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Between group differences in lean mass at week 16
Ramy czasowe: Week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16
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Between group differences in lean mass at week 36
Ramy czasowe: Week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 36
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Changes from baseline in lean mass at week 16
Ramy czasowe: Baseline and week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 16
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Changes from baseline in lean mass at week 36
Ramy czasowe: Baseline and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 36
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Changes from week 16 in lean mass at week 36
Ramy czasowe: Week 16 and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16 and week 36
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Between group differences in lumbar spine bone mineral density at week 16
Ramy czasowe: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in lumbar spine bone mineral density at week 36
Ramy czasowe: Week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in lumbar spine bone mineral density at week 16
Ramy czasowe: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in lumbar spine bone mineral density at week 36
Ramy czasowe: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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Changes from week 16 in lumbar spine bone mineral density at week 36
Ramy czasowe: Week 16 and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in dominant femur bone mineral density at week 16
Ramy czasowe: Week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in dominant femur bone mineral density at week 36
Ramy czasowe: Week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in dominant femur bone mineral density at week 16
Ramy czasowe: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in dominant femur bone mineral density at week 36
Ramy czasowe: Baseline and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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Changes from week 16 in dominant femur bone mineral density at week 36
Ramy czasowe: Week 16 and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in dominant femoral neck bone mineral density at week 16
Ramy czasowe: Week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in dominant femoral neck bone mineral density at week 36
Ramy czasowe: Week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in dominant femoral neck bone mineral density at week 16
Ramy czasowe: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in dominant femoral neck bone mineral density at week 36
Ramy czasowe: Baseline and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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Changes from week 16 in dominant femoral neck bone mineral density at week 36
Ramy czasowe: Week 16 and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in lumbar spine bone mineral content at week 16
Ramy czasowe: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in lumbar spine bone mineral content at week 36
Ramy czasowe: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in lumbar spine bone mineral content at week 16
Ramy czasowe: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in lumbar spine bone mineral content at week 36
Ramy czasowe: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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Changes from week 16 in lumbar spine bone mineral content at week 36
Ramy czasowe: Week 16 and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in dominant femur bone mineral content at week 16
Ramy czasowe: Week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in dominant femur bone mineral content at week 36
Ramy czasowe: Week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in dominant femur bone mineral content at week 16
Ramy czasowe: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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|
Changes from baseline in dominant femur bone mineral content at week 36
Ramy czasowe: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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Changes from week 16 in dominant femur bone mineral content at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in dominant femoral neck bone mineral content at week 16
Ramy czasowe: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in dominant femoral neck bone mineral content at week 36
Ramy czasowe: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in dominant femoral neck bone mineral content at week 16
Ramy czasowe: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in dominant femoral neck bone mineral content at week 36
Ramy czasowe: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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Changes from week 16 in dominant femoral neck bone mineral content at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in osteocalcin at week 16
Ramy czasowe: Week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16
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Between group differences in osteocalcin at week 36
Ramy czasowe: Week 36
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 36
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Changes from baseline in osteocalcin at week 16
Ramy czasowe: Baseline and week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 16
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Changes from baseline in osteocalcin at week 36
Ramy czasowe: Baseline and week 36
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 36
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Changes from week 16 in osteocalcin at week 36
Ramy czasowe: Week 16 and week 36
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16 and week 36
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Between group differences in procollagen type-1 amino-terminal propeptide at week 16
Ramy czasowe: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16
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Between group differences in procollagen type-1 amino-terminal propeptide at week 36
Ramy czasowe: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
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Changes from baseline in procollagen type-1 amino-terminal propeptide at week 16
Ramy czasowe: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 16
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Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36
Ramy czasowe: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 36
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Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16 and week 36
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Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16
Ramy czasowe: Week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16
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Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36
Ramy czasowe: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 36
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Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16
Ramy czasowe: Baseline and week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 16
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Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36
Ramy czasowe: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 36
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Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16 and week 36
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Between group differences in sclerostin at week 16
Ramy czasowe: Week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16
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Between group differences in sclerostin at week 36
Ramy czasowe: Week 36
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 36
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Changes from baseline in sclerostin at week 16
Ramy czasowe: Baseline and week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 16
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Changes from baseline in sclerostin at week 36
Ramy czasowe: Baseline and week 36
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 36
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Changes from week 16 in sclerostin at week 36
Ramy czasowe: Week 16 and week 36
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16 and week 36
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Between group differences in isometric knee extension peak torque at week 16
Ramy czasowe: Week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 16
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Between group differences in isometric knee extension peak torque at week 36
Ramy czasowe: Week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 36
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Changes from baseline in isometric knee extension peak torque at week 16
Ramy czasowe: Baseline and week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Baseline and week 16
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Changes from baseline in isometric knee extension peak torque at week 36
Ramy czasowe: Baseline and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Baseline and week 36
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Changes from week 16 in isometric knee extension peak torque at week 36
Ramy czasowe: Week 16 and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 16 and week 36
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Between group differences in isometric knee extension rate of force development at week 16
Ramy czasowe: Week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 16
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Between group differences in isometric knee extension rate of force development at week 36
Ramy czasowe: Week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 36
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Changes from baseline in isometric knee extension rate of force development at week 16
Ramy czasowe: Baseline and week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Baseline and week 16
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Changes from baseline in isometric knee extension rate of force development at week 36
Ramy czasowe: Baseline and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Baseline and week 36
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Changes from week 16 in isometric knee extension rate of force development at week 36
Ramy czasowe: Week 16 and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 16 and week 36
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Between group differences in upper body strength at week 16
Ramy czasowe: Week 16
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Determined by a handgrip dynamometer.
|
Week 16
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Between group differences in upper body strength at week 36
Ramy czasowe: Week 36
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Determined by a handgrip dynamometer.
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Week 36
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Changes from baseline in upper body strength at week 16
Ramy czasowe: Baseline and week 16
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Determined by a handgrip dynamometer.
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Baseline and week 16
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Changes from baseline in upper body strength at week 36
Ramy czasowe: Baseline and week 36
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Determined by a handgrip dynamometer.
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Baseline and week 36
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Changes from week 16 in upper body strength at week 36
Ramy czasowe: Week 16 and week 36
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Determined by a handgrip dynamometer.
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Week 16 and week 36
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Between group differences in postural balance at week 16
Ramy czasowe: Week 16
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Determined by the number of falls in a single-legged flamingo balance test.
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Week 16
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Between group differences in postural balance at week 36
Ramy czasowe: Week 36
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Determined by the number of falls in a single-legged flamingo balance test.
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Week 36
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Changes from baseline in postural balance at week 16
Ramy czasowe: Baseline and week 16
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Determined by the number of falls in a single-legged flamingo balance test.
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Baseline and week 16
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Changes from baseline in postural balance at week 36
Ramy czasowe: Baseline and week 36
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Determined by the number of falls in a single-legged flamingo balance test.
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Baseline and week 36
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Changes from week 16 in postural balance at week 36
Ramy czasowe: Week 16 and week 36
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Determined by the number of falls in a single-legged flamingo balance test.
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Week 16 and week 36
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Between group differences in aerobic performance at week 16
Ramy czasowe: Week 16
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Week 16
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Between group differences in aerobic performance at week 36
Ramy czasowe: Week 36
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Week 36
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Changes from baseline in aerobic performance at week 16
Ramy czasowe: Baseline and week 16
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Baseline and week 16
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Changes from baseline in aerobic performance at week 36
Ramy czasowe: Baseline and week 36
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Baseline and week 36
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Changes from week 16 in aerobic performance at week 36
Ramy czasowe: Week 16 and week 36
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Week 16 and week 36
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Between group differences in total cholesterol at week 16
Ramy czasowe: Week 16
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Determined by an automated analyser.
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Week 16
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Between group differences in total cholesterol at week 36
Ramy czasowe: Week 36
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Determined by an automated analyser.
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Week 36
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Changes from baseline in total cholesterol at week 16
Ramy czasowe: Baseline and week 16
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Determined by an automated analyser.
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Baseline and week 16
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Changes from baseline in total cholesterol at week 36
Ramy czasowe: Baseline and week 36
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Determined by an automated analyser.
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Baseline and week 36
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Changes from week 16 in total cholesterol at week 36
Ramy czasowe: Week 16 and week 36
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Determined by an automated analyser.
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Week 16 and week 36
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Between group differences in high-density lipoprotein cholesterol at week 16
Ramy czasowe: Week 16
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Determined by an automated analyser.
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Week 16
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Between group differences in high-density lipoprotein cholesterol at week 36
Ramy czasowe: Week 36
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Determined by an automated analyser.
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Week 36
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Changes from baseline in high-density lipoprotein cholesterol at week 16
Ramy czasowe: Baseline and week 16
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Determined by an automated analyser.
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Baseline and week 16
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Changes from baseline in high-density lipoprotein cholesterol at week 36
Ramy czasowe: Baseline and week 36
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Determined by an automated analyser.
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Baseline and week 36
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Changes from week 16 in high-density lipoprotein cholesterol at week 36
Ramy czasowe: Week 16 and week 36
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Determined by an automated analyser.
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Week 16 and week 36
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Between group differences in low-density lipoprotein cholesterol at week 16
Ramy czasowe: Week 16
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Determined by an automated analyser.
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Week 16
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Between group differences in low-density lipoprotein cholesterol at week 36
Ramy czasowe: Week 36
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Determined by an automated analyser.
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Week 36
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Changes from baseline in low-density lipoprotein cholesterol at week 16
Ramy czasowe: Baseline and week 16
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Determined by an automated analyser.
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Baseline and week 16
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Changes from baseline in low-density lipoprotein cholesterol at week 36
Ramy czasowe: Baseline and week 36
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Determined by an automated analyser.
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Baseline and week 36
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Changes from week 16 in low-density lipoprotein cholesterol at week 36
Ramy czasowe: Week 16 and week 36
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Determined by an automated analyser.
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Week 16 and week 36
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Between group differences in triglycerides at week 16
Ramy czasowe: Week 16
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Determined by an automated analyser.
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Week 16
|
|
Between group differences in triglycerides at week 36
Ramy czasowe: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in triglycerides at week 16
Ramy czasowe: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in triglycerides at week 36
Ramy czasowe: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in triglycerides at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in fasting glucose at week 16
Ramy czasowe: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in fasting glucose at week 36
Ramy czasowe: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in fasting glucose at week 16
Ramy czasowe: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in fasting glucose at week 36
Ramy czasowe: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in fasting glucose at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in fasting insulin at week 16
Ramy czasowe: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in fasting insulin at week 36
Ramy czasowe: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Change from baseline in fasting insulin at week 16
Ramy czasowe: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Change from baseline in fasting insulin at week 36
Ramy czasowe: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Change from week 16 in fasting insulin at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in glucose tolerance at week 16
Ramy czasowe: Week 16
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 16
|
|
Between group differences in glucose tolerance at week 36
Ramy czasowe: Week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 36
|
|
Changes from baseline in glucose tolerance at week 16
Ramy czasowe: Baseline and week 16
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in glucose tolerance at week 36
Ramy czasowe: Baseline and week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in glucose tolerance at week 36
Ramy czasowe: Week 16 and week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 16 and week 36
|
Współpracownicy i badacze
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Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
2 stycznia 2016
Zakończenie podstawowe (Rzeczywisty)
1 marca 2018
Ukończenie studiów (Rzeczywisty)
1 marca 2018
Daty rejestracji na studia
Pierwszy przesłany
14 marca 2022
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 marca 2022
Pierwszy wysłany (Rzeczywisty)
23 marca 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
6 kwietnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 marca 2022
Ostatnia weryfikacja
1 marca 2022
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- CEFADE202019
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .