ObesityPOWERNCT04777305
The POWER BARIATRIC Trial: Physical Outcomes With Exercise Regimens on BARIATRIC Patients
A study testing Physical activity training in people with Obesity and Muscle Loss, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Muscle Loss, Adiposity
- What is being tested?
- Physical activity training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2021to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv, Other, 6997801
Yftach Gepner
About this study
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).
Read the detailed description
The primary aim will be 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 BS, despite the rapid surgery-induced weight loss.
Secondary aims will include: I. To examine the effect of different exercise regimens on the composition and diversity of microbiomes, and their role in mediating muscle mass preservation following BS. II.Evaluate changes in cardiometabolic markers and endocrine response to different exercise regimens and evaluates microbiome mediation of these changes after BS. III.Assess the effect of different exercise regimens on physical function among patients following BS. IV.Clarify the mechanisms of muscle preservation and fat loss involving hormonal response and atrophy related-genes expression.
After baseline measurements (detailed below), participants will be randomized into one of four groups: 1. control group (n=15) that includes routine health care; 2. aerobic exercise training group (n=15), 3. resistance exercise training group (n=15), 4. combined aerobic and resistance exercise training group (n=15). Training sessions will be both in-person and as online exercise supervision. All groups will be supported by a dietitian as part of the routine health care after the bariatric surgery. The dietetic program for all groups will consist of a balanced diet by diet progression guidelines for bariatric patients (XX,ZZ) and the bariatric food pyramid (55). The protein content will be a minimum of 60 gr/protein per day, according to current guidelines (XX,ZZ) . Each training session will increase gradually up to 60 minutes per session, three times a week. Participants will be randomized into 4 groups for 26 weeks of intervention including aerobic, resistance, combined exercise training (aerobic + resistance) and a control group without exercise training.
All exercise training will be matched in metabolic equivalent (METs) and the time of training per week. Participants will begin a two weeks exercise adaptation period at 3-4 postoperative weeks. The activity adaptation plan will consist of 15-20 min. of walking, three times per week, at an intensity of 40-60% of peak oxygen consumption (VO2) or rate of perceived exertion (RPE) 4-6 on the Borg scale for all intervention groups. Following this period, each group will participate in a specific progressive training with the following regimen:
- 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 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.
- 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 bodyweight exercises.
- 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. Afterward, 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.
- The control group will receive conventional treatment so as the other groups (medical and nutritional follow up).
- Conditions
- Obesity, Muscle Loss, Adiposity
- Being tested
- Physical activity training
- Keywords
- Obesity, Bariatric Surgery, Muscle mass loss, exercise training
- Medical subject headings
- Obesity, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass (cm3)
Changes in thigh muscles volume
Measured: At baseline and after 26 weeks of intervention
Body composition - fat mass
Fat mass (Kg)
Measured: At baseline and after 13 and 26 weeks of intervention
Body composition
Fat free mass (Kg)
Measured: At baseline and after 13 and 26 weeks of intervention
Secondary outcomes (16)
Microbial composition and changes
16S rRNA profiling
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements - cardiometabolic markers
Cardiometabolic markers: Glucose (mg/dl), lipid profile (total cholesterol in mg/dl, HDL in mg/dl, LDL in mg/dl)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements - Insulin
Insulin (pmol/L)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements for skeletal muscle metabolism assessment
Levels of anabolic hormones such as growth hormone (ng/ml) (GH), insulin like growth factor (ng/ml) (IGF-1).
Marker of inhibition of skeletal muscle growth: Myostatin (ng/ml)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements - Inflammatory markers
Interleukin-6 (pg/ml) (IL6)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements for nutritional status
Markers for nutritional status: Hemoglobin (g/dl), albumin (g/dl)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements for micronutrients
Ferritin (ng/ml), B12 (ng/ml)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements for liver function
Liver enzymes: alanine aminotransferase in units per liter (U/L) (AST), gamma-glutamyltransferase (U/L)(GGT), alanine aminotransferase (U/L) (ALT), alkaline phosphatase (U/L) (ALP);
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements of adipokines - leptin
Leptin (ng/ml)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements of adipokines - adiponectin
Adiponectin (μg/ml)
Measured: At baseline and after 13 and 26 weeks of intervention
Blood measurements for bone status
Blood bone markers such as Collagen Type-1 C-Telopeptide in μg/L (CTX) and total procollagen type 1 N-terminal propeptide in μg/L (P1NP).
Measured: At baseline and after 13 and 26 weeks of intervention
Bone density changes
Assessed by DEXA scan (T score and g/cm^2)
Measured: At baseline and after 13 and 26 weeks of intervention
Anthropometric measurements - BMI
Weight (kg) and height (m) will be combined to calculate BMI (kg/m^2)
Measured: At baseline and after 13 and 26 weeks of intervention
waist circumference as part of Anthropometric measurements
waist circumference (cm)
Measured: At baseline and after 13 and 26 weeks of intervention
Weight loss percentage outcomes
% Excess weight loss (%EWL) will be calculated by [(initial weight (kg))-(post operative weight(kg))] / [(initial weight in kg) - (ideal body weight in kg)].
Total weight loss % (TWL%) will be calculated by [(initial weight (kg))-(post operative weight(kg))] / initial weight (kg).
Measured: At baseline and after 13 and 26 weeks of intervention
Resting metabolic rate
measurement of resting daily energy expenditure (Kcal) will be measured by indirect calorimetry (Kcal/day) and energy expenditure per body kilogram per day (Kcal/Kg/day).
Measured: At baseline and after 13 and 26 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Aug 2021
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Herzliya Medical Center
- Responsible party
- Principal investigator, Gepner Yftach, Tel Aviv University
- Investigators
- Yftach Gepner, Ph.D., Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777305
- Sponsor's protocol ID
- 0010-20-HMC
- Acronym
- POWER
- Status last verified
- Oct 2023
- First submitted
- 8 Feb 2021
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldenshluger A, Friedman L, Turjeman T, Yavetz R, Raziel A, Goitein D, Markus I, Kais H, Sternfeld R, Trachtenberg E, Dubnov-Raz G, Mhaler I, Youngster I, Peled D, Amedi R, Keidar A, Livingston EH, Sakran N, Dicker D, Gepner Y. Exercise Modalities to Preserve Muscle Mass and Bone Health After Metabolic Bariatric Surgery. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70289. doi: 10.1002/jcsm.70289.
PubMed 42057763Friedman L, Goldenshluger A, Turjeman T, Raziel A, Goitein D, Kais H, Dubnov-Raz G, Mhaler I, Youngster I, Knaan T, Peled D, Amedi R, Yavetz R, Keidar A, Livingston EH, Sakran N, Melanson EL, Dicker D, Gepner Y. Liver and Kidney volume Reduction May Underlie Metabolic Adaptation After Metabolic Bariatric Surgery: A sub-study of the "POWER" Randomized clinical trial. Clin Nutr. 2026 May;60:106623. doi: 10.1016/j.clnu.2026.106623. Epub 2026 Mar 11.
PubMed 41875670
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The POWER BARIATRIC Trial: Physical Outcomes With Exercise Regimens on BARIATRIC Patients
- ClinicalTrials.gov ID
- NCT04777305
- Acronym / sponsor ID
- POWER / 0010-20-HMC
- Conditions
- Obesity, Muscle Loss, Adiposity
- Keywords
- Obesity, Bariatric Surgery, Muscle mass loss, exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Herzliya Medical Center
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The primary aim will be 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 BS, despite the rapid surgery-induced weight loss.
Secondary aims will include: I. To examine the effect of different exercise regimens on the composition and diversity of microbiomes, and their role in mediating muscle mass preservation following BS. II.Evaluate changes in cardiometabolic markers and endocrine response to different exercise regimens and evaluates microbiome mediation of these changes after BS. III.Assess the effect of different exercise regimens on physical function among patients following BS. IV.Clarify the mechanisms of muscle preservation and fat loss involving hormonal response and atrophy related-genes expression.
After baseline measurements (detailed below), participants will be randomized into one of four groups: 1. control group (n=15) that includes routine health care; 2. aerobic exercise training group (n=15), 3. resistance exercise training group (n=15), 4. combined aerobic and resistance exercise training group (n=15). Training sessions will be both in-person and as online exercise supervision. All groups will be supported by a dietitian as part of the routine health care after the bariatric surgery. The dietetic program for all groups will consist of a balanced diet by diet progression guidelines for bariatric patients (XX,ZZ) and the bariatric food pyramid (55). The protein content will be a minimum of 60 gr/protein per day, according to current guidelines (XX,ZZ) . Each training session will increase gradually up to 60 minutes per session, three times a week. Participants will be randomized into 4 groups for 26 weeks of intervention including aerobic, resistance, combined exercise training (aerobic + resistance) and a control group without exercise training.
All exercise training will be matched in metabolic equivalent (METs) and the time of training per week. Participants will begin a two weeks exercise adaptation period at 3-4 postoperative weeks. The activity adaptation plan will consist of 15-20 min. of walking, three times per week, at an intensity of 40-60% of peak oxygen consumption (VO2) or rate of perceived exertion (RPE) 4-6 on the Borg scale for all intervention groups. Following this period, each group will participate in a specific progressive training with the following regimen:
- 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 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.
- 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 bodyweight exercises.
- 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. Afterward, 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.
- The control group will receive conventional treatment so as the other groups (medical and nutritional follow up).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training | Experimental | Other: Physical activity trainingThe 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. |
| Resistance exercise training | Experimental | Other: Physical activity trainingResistance 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. |
| Combination exercise training | Experimental | Other: Physical activity trainingThe 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. |
| The control group | No intervention | –The control group will receive routine health care without exercise supervision (clinical and nutritional follow up). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity trainingParticipants 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. | Other | Aerobic exercise training, Combination exercise training, Resistance exercise training |
Primary outcome
Muscle mass (cm3)
Time frame: At baseline and after 26 weeks of intervention
Changes in thigh muscles volume
Body composition - fat mass
Time frame: At baseline and after 13 and 26 weeks of intervention
Fat mass (Kg)
Body composition
Time frame: At baseline and after 13 and 26 weeks of intervention
Fat free mass (Kg)
16 secondary outcomes
Microbial composition and changes
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements - cardiometabolic markers
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements - Insulin
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements for skeletal muscle metabolism assessment
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements - Inflammatory markers
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements for nutritional status
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements for micronutrients
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements for liver function
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements of adipokines - leptin
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements of adipokines - adiponectin
Time frame: At baseline and after 13 and 26 weeks of intervention
Blood measurements for bone status
Time frame: At baseline and after 13 and 26 weeks of intervention
Bone density changes
Time frame: At baseline and after 13 and 26 weeks of intervention
Anthropometric measurements - BMI
Time frame: At baseline and after 13 and 26 weeks of intervention
waist circumference as part of Anthropometric measurements
Time frame: At baseline and after 13 and 26 weeks of intervention
Weight loss percentage outcomes
Time frame: At baseline and after 13 and 26 weeks of intervention
Resting metabolic rate
Time frame: At baseline and after 13 and 26 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Derived from this study: PubMed 42057763Goldenshluger A, Friedman L, Turjeman T, Yavetz R, Raziel A, Goitein D, Markus I, Kais H, Sternfeld R, Trachtenberg E, Dubnov-Raz G, Mhaler I, Youngster I, Peled D, Amedi R, Keidar A, Livingston EH, Sakran N, Dicker D, Gepner Y. Exercise Modalities to Preserve Muscle Mass and Bone Health After Metabolic Bariatric Surgery. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70289. doi: 10.1002/jcsm.70289.
- Derived from this study: PubMed 41875670Friedman L, Goldenshluger A, Turjeman T, Raziel A, Goitein D, Kais H, Dubnov-Raz G, Mhaler I, Youngster I, Knaan T, Peled D, Amedi R, Yavetz R, Keidar A, Livingston EH, Sakran N, Melanson EL, Dicker D, Gepner Y. Liver and Kidney volume Reduction May Underlie Metabolic Adaptation After Metabolic Bariatric Surgery: A sub-study of the "POWER" Randomized clinical trial. Clin Nutr. 2026 May;60:106623. doi: 10.1016/j.clnu.2026.106623. Epub 2026 Mar 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yftach Gepner, Ph.D. principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity training in people with Obesity and Muscle Loss, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yftach Gepner, Ph.D. (+972733804726, gepner@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (cm3) (time frame: At baseline and after 26 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04777305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.