The POWER BARIATRIC Trial: Physical Outcomes With Exercise Regimens on BARIATRIC Patients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to determine how different types of exercise regimens (resistance, aerobic, or combined exercise regimens) can be used to minimize muscle loss and mobilize body fat in severely obese patients after bariatric surgery (BS), despite the rapid surgery-induced weight loss. Additionally, the study will examine how changes in the intestinal microbiota following BS act as a mediation factor that alter tissue-specific responses in muscle and adipose tissue. The study will also evaluate the effect of different types of exercise regimens on cardiometabolic markers, endocrine response, and physical function following BS. Sixty sedentary (regular exercise \<1 hour per week) candidates to bariatric surgery at Herzliya Medical Center will be recruited to participate in this six-month-long randomized control study. Participants will be randomly assigned to either one of three exercise regimens intervention groups (aerobic, resistance, or a combined exercise regimen combining aerobic and resistance exercises) or a control group that will receive standard care. Training will be supervised and matched for metabolic equivalent (METs). The intervention will take place at the Sylvan Adams Sports Institute at Tel Aviv University and an online platform. All measurements will be taken at a presurgical baseline assessment and throughout the study, and will include changes of muscle mass and adipose tissue distribution, measured by a 3-Tesla magnetic resonance imaging (MRI); body composition- will be assessed using multichannel bioelectrical impedance (Seca); Bone mass, will be measured by a Dual-energy X-ray absorptiometry (DEXA); microbiota composition and changes will be evaluated by stool samples that will be subjected to 16S ribosomal ribonucleic acid (16s rRNA) profiling and metagenomics analysis; fasting blood samples will be used to examine endocrine control and cardiometabolic markers; anthropometric measurements to assess surgery results associations with physical activity outcomes and physical function will be assessed by several validated performance assessments, including handgrip, six-minute walk, sit-to-stand, maximum voluntary contraction, and maximal oxygen consumption (VO2max).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: t
View:

• Sedentary participants: regular exercise performed \<1 hour per week

• Candidates for primary bariatric surgery at Herzliya Medical Center in accordance to the National Institutes of Health (NIH) criteria for surgery: (body mass index (BMI) \> 40 without coexisting co-morbidities or BMI \> 35 with \> 1 severe obesity-related comorbidities)

• Sex: all

• Age: 18 to 65 years.

Locations
Other Locations
Israel
Tel Aviv University
RECRUITING
Tel Aviv
Contact Information
Primary
Yftach Gepner, Ph.D.
gepner@tauex.tau.ac.il
+972733804726
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2024-10-30
Participants
Target number of participants: 60
Treatments
Experimental: Aerobic exercise training
The aerobic exercise training group, weeks 5-8 after surgery: this training will consist of 30 min. of walking, 3 times per week at an intensity of 60-70% of peak VO2 or RPE 6-7 on the Borg scale.~Weeks 9-26 after surgery: this training will consist of 60 minutes of exercise, 3 times per week at an intensity of 65-80% of peak VO2 or RPE 6-8 on the Borg scale. The aerobic exercises will consist of a treadmill or outside walking or running, stationary cycling or elliptical trainer in continuous and interval training.
Experimental: Resistance exercise training
Resistance exercise training group, weeks 5-8 after surgery: this training will consist of 5-10 minutes of warmup, followed by 6-8 multi-joint exercises for major muscle groups, comprising 2 sets of 10 to 25 repetitions at 40% of the one-repetition maximum (1-RM) for each exercise. The intensity will increase on weeks 9-26 after surgery to 8-10 multi-joint exercises of 3-4 sets of 10 to 25 repetitions. For this training participants will use free-weights and body weight exercises.
Experimental: Combination exercise training
The combination exercise training will consist of a combined aerobic and resistance exercise training sessions three times weekly. At weeks 5-8 after surgery the sessions will include 5-10 minutes of warmup, followed by 3-4 multi-joint exercises for major muscle groups, comprising 2 sets of 10 to 25 repetitions at 40% of the one-repetition maximum (1-RM) for each exercise. Afterwards the aerobic part of the training will consist of 10-15 minutes of aerobic exercises (treadmill or outside walking or running, stationary cycling or outdoors or elliptical trainer) at 60-70% of peak VO2 or RPE 6-7 at Borg scale.~The intensity will increase on weeks 9-26 after surgery to 4-5 multi-joint exercises of 3-4 sets of 10 to 25 repetitions and 30 minutes of aerobic exercises at 65-80% of peak VO2 or RPE 6-8 at Borg scale.
No_intervention: The control group
The control group will receive routine health care without exercise supervision (clinical and nutritional follow up).
Related Therapeutic Areas
Sponsors
Leads: Tel Aviv University
Collaborators: Herzliya Medical Center

This content was sourced from clinicaltrials.gov

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