Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women (H4HW)
28. marts 2022 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Porto
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Maia, Porto, Portugal, 4476-690
- University of Maia
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Ingen indgriben: Control group
The control group participants were instructed to keep their regular daily physical activity for 36 weeks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Between group differences in peak oxygen uptake at week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Between group differences in resting heart rate at week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 lean mass at week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 lumbar spine bone mineral density at week 36
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 lumbar spine bone mineral density at week 36
Tidsramme: 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 femur bone mineral density at week 16
Tidsramme: 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
Tidsramme: 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 femur bone mineral density at week 16
Tidsramme: 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
Tidsramme: 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 density at week 36
Tidsramme: 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 density at week 16
Tidsramme: 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
Tidsramme: 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 density at week 16
Tidsramme: Baseline and week 16
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 lumbar spine bone mineral content at week 36
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 lumbar spine bone mineral content at week 36
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 content at week 36
Tidsramme: 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 content at week 16
Tidsramme: 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 content at week 36
Tidsramme: 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 content at week 16
Tidsramme: 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
Tidsramme: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
|
|
Changes from week 16 in dominant femoral neck bone mineral content at week 36
Tidsramme: 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
Tidsramme: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
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Between group differences in osteocalcin at week 36
Tidsramme: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
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Changes from baseline in osteocalcin at week 16
Tidsramme: 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
Tidsramme: 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 osteocalcin at week 36
Tidsramme: 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 procollagen type-1 amino-terminal propeptide at week 16
Tidsramme: Week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
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Between group differences in procollagen type-1 amino-terminal propeptide at week 36
Tidsramme: 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 procollagen type-1 amino-terminal propeptide at week 16
Tidsramme: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
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Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36
Tidsramme: 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
Tidsramme: 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 carboxy-terminal type-1 collagen crosslinks at week 16
Tidsramme: Week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
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Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36
Tidsramme: 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
Tidsramme: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
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Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36
Tidsramme: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
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|
Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36
Tidsramme: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
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Between group differences in sclerostin at week 16
Tidsramme: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
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Between group differences in sclerostin at week 36
Tidsramme: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
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Changes from baseline in sclerostin at week 16
Tidsramme: 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 sclerostin at week 36
Tidsramme: 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 sclerostin at week 36
Tidsramme: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
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|
Between group differences in isometric knee extension peak torque at week 16
Tidsramme: 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
Tidsramme: Week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 36
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Changes from baseline in isometric knee extension peak torque at week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16 and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16 and week 36
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Between group differences in isometric knee extension rate of force development at week 16
Tidsramme: Week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16
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Between group differences in isometric knee extension rate of force development at week 36
Tidsramme: Week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 36
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Changes from baseline in isometric knee extension rate of force development at week 16
Tidsramme: Baseline and week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Baseline and week 16
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Changes from baseline in isometric knee extension rate of force development at week 36
Tidsramme: 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
Tidsramme: Week 16 and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16 and week 36
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Between group differences in upper body strength at week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16
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Determined by an automated analyser.
|
Week 16
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Between group differences in total cholesterol at week 36
Tidsramme: Week 36
|
Determined by an automated analyser.
|
Week 36
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Changes from baseline in total cholesterol at week 16
Tidsramme: 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
Tidsramme: Baseline and week 36
|
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
Tidsramme: 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
Tidsramme: Week 16
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Determined by an automated analyser.
|
Week 16
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Between group differences in high-density lipoprotein cholesterol at week 36
Tidsramme: Week 36
|
Determined by an automated analyser.
|
Week 36
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Changes from baseline in high-density lipoprotein cholesterol at week 16
Tidsramme: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
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Changes from baseline in high-density lipoprotein cholesterol at week 36
Tidsramme: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
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Changes from week 16 in high-density lipoprotein cholesterol at week 36
Tidsramme: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
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Between group differences in low-density lipoprotein cholesterol at week 16
Tidsramme: Week 16
|
Determined by an automated analyser.
|
Week 16
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Between group differences in low-density lipoprotein cholesterol at week 36
Tidsramme: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in low-density lipoprotein cholesterol at week 16
Tidsramme: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
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|
Changes from baseline in low-density lipoprotein cholesterol at week 36
Tidsramme: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in low-density lipoprotein cholesterol at week 36
Tidsramme: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in triglycerides at week 16
Tidsramme: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in triglycerides at week 36
Tidsramme: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in triglycerides at week 16
Tidsramme: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in triglycerides at week 36
Tidsramme: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in triglycerides at week 36
Tidsramme: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in fasting glucose at week 16
Tidsramme: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in fasting glucose at week 36
Tidsramme: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in fasting glucose at week 16
Tidsramme: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in fasting glucose at week 36
Tidsramme: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in fasting glucose at week 36
Tidsramme: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in fasting insulin at week 16
Tidsramme: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in fasting insulin at week 36
Tidsramme: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Change from baseline in fasting insulin at week 16
Tidsramme: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Change from baseline in fasting insulin at week 36
Tidsramme: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Change from week 16 in fasting insulin at week 36
Tidsramme: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in glucose tolerance at week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16 and week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 16 and week 36
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. januar 2016
Primær færdiggørelse (Faktiske)
1. marts 2018
Studieafslutning (Faktiske)
1. marts 2018
Datoer for studieregistrering
Først indsendt
14. marts 2022
Først indsendt, der opfyldte QC-kriterier
14. marts 2022
Først opslået (Faktiske)
23. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CEFADE202019
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .