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

NCT04777305 | Unknown

• 1 other identifier: 0010-20-HMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity; Muscle Loss; Adiposity

Keywords

Obesity; Bariatric Surgery; Muscle mass loss; exercise training

Outcome Measures

Primary Outcomes (3)

• Muscle mass (cm3)

  Changes in thigh muscles volume

  At baseline and after 26 weeks of intervention

• Body composition - fat mass

  Fat mass (Kg)

  At baseline and after 13 and 26 weeks of intervention

• Body composition

  Fat free mass (Kg)

  At baseline and after 13 and 26 weeks of intervention

Secondary Outcomes (16)

• Microbial composition and changes

  At baseline and after 13 and 26 weeks of intervention

• Blood measurements - cardiometabolic markers

  At baseline and after 13 and 26 weeks of intervention

• Blood measurements - Insulin

  At baseline and after 13 and 26 weeks of intervention

• Blood measurements for skeletal muscle metabolism assessment

  At baseline and after 13 and 26 weeks of intervention

• Blood measurements - Inflammatory markers

  At baseline and after 13 and 26 weeks of intervention

Other Outcomes (6)

• Quality of life (QoL)

  At baseline and after 13 and 26 weeks of intervention

• Physical function - 6 min walk test

  At baseline and after 13 and 26 weeks of intervention

• Physical function - sit to stand test

  At baseline and after 13 and 26 weeks of intervention

Study Arms (4)

Aerobic exercise training

EXPERIMENTAL

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.

Other: Physical activity training

Resistance exercise training

EXPERIMENTAL

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.

Other: Physical activity training

Combination exercise training

EXPERIMENTAL

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.

Other: Physical activity training

The control group

NO INTERVENTION

The control group will receive routine health care without exercise supervision (clinical and nutritional follow up).

Interventions

Physical activity training OTHER

Participants will be randomized into either one of three intervention groups (aerobic training, resistance training, or combined training comprised of resistance and aerobic training) and a control group. Training is described in the arm description section.

Aerobic exercise training; Combination exercise training; Resistance exercise training

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe cardiopulmonary disease (e.g., recent myocardial infarction or unstable angina)
• Musculoskeletal or neuromuscular impairments that preclude exercise training
• Cognitive impairments
• Use of drugs that affect bone or muscle metabolism (mainly steroids)
• Patients with previous bariatric surgery

Sponsors & Collaborators

• Tel Aviv University: lead
• Herzliya Medical Center: collaborator

Study Sites (1)

Tel Aviv University

Tel Aviv, Other, 6997801, Israel

RECRUITING

MeSH Terms

Conditions

Obesity; Muscular Atrophy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Yftach Gepner, Ph.D.

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yftach Gepner, Ph.D.

CONTACT

+972733804726; gepner@tauex.tau.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gepner Yftach

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 2, 2021
• Study Start: August 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)