- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03921853
Resistance Training in Patients With Morbid Obesity (ExinMO)
Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.
Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Llanquihue
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Osorno, Llanquihue, Chile, 5290000
- Cristian ALvarez
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Inclusion Criteria:
- Older than 18 and younger and ≤65 years of age.
- With risk factors to Metabolic syndrome
- With obesity and morbid obesity condition
- Medical authorization by a physician.
Exclusion Criteria:
- Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
- Exercise-related dyspnoea or respiratory alterations.
- Chronic heart disease with any worsening in the last month.
- Adherence rate of less than 80% of the total interventions.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Aktywny komparator: Active comparator
Control group with obesity under Resistant Training
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The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group.
All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries.
Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors.
The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery.
Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
Inne nazwy:
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Eksperymentalny: Experimental group with morbid obesity
Experimental group with morbid obesity under Resistant Training
|
The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group.
All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries.
Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors.
The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery.
Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Fasting glucose
Ramy czasowe: Change from Baseline Fasting glucose at 20-weeks of Resistant Training
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Component of the Metabolic Syndrome
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Change from Baseline Fasting glucose at 20-weeks of Resistant Training
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High density lipoprotein
Ramy czasowe: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
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Component of the Metabolic Syndrome
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Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
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Systolic blood pressure and diastolic blood pressure
Ramy czasowe: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
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Component of the Metabolic Syndrome
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from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
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Waist circumference
Ramy czasowe: Change from Baseline Waist circumference at 20-weeks of Resistant Training
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Component of the Metabolic Syndrome
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Change from Baseline Waist circumference at 20-weeks of Resistant Training
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Triglycerides
Ramy czasowe: Change from Baseline Triglycerides at 20-weeks of Resistant Training
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Component of the Metabolic Syndrome
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Change from Baseline Triglycerides at 20-weeks of Resistant Training
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Body mass index
Ramy czasowe: Change from Baseline Body mass index at 20-weeks of Resistant Training
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Anthropometric
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Change from Baseline Body mass index at 20-weeks of Resistant Training
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Body mass
Ramy czasowe: Change from Baseline Body mass at 20-weeks of Resistant Training
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Anthropometric
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Change from Baseline Body mass at 20-weeks of Resistant Training
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Total cholesterol
Ramy czasowe: Change from Baseline Total cholesterol at 20-weeks of Resistant Training
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Measured by plasma sample
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Change from Baseline Total cholesterol at 20-weeks of Resistant Training
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Low density lipoprotein
Ramy czasowe: Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
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Measured by plasma sample
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Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
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Six minutes walking test
Ramy czasowe: Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
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Endurance performance
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Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
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One maximum repetition of biceps curl
Ramy czasowe: Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
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Strength Performance
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Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
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Handgrip muscle strength
Ramy czasowe: Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training
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Muscle strength
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Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Cristian ALvarez, PhD, Universidad de Los Lagos
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RP08042019
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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