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

Obesity Clinical Trial

— POWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777305
• Other study ID #: 0010-20-HMC
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: October 2023
• Source: Tel Aviv University
• Contact: Yftach Gepner, Ph.D.
• Phone: +972733804726
• Email: gepner[@]tauex.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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:

1. 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.

2. 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.

3. 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.

4. The control group will receive conventional treatment so as the other groups (medical and nutritional follow up).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adiposity
• Muscle Loss
• Obesity

Intervention

Other:
• Physical activity training
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.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv	Other

Sponsors (2)

Lead Sponsor	Collaborator
Tel Aviv University	Herzliya Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life (QoL)	Will be assessed by the Bariatric Analysis and Reporting Outcome System (BAROS) questionnaire- measured by the results score	At baseline and after 13 and 26 weeks of intervention
Other	Physical function - 6 min walk test	6 min walk test will be assessed in meters	At baseline and after 13 and 26 weeks of intervention
Other	Physical function - sit to stand test	Sit to stand test will be assessed in seconds	At baseline and after 13 and 26 weeks of intervention
Other	Strength assessment	Will be assessed by performance tests Handgrip test (kg), Estimated one-repetition maximum (the maximum weight a participant can lift, in one attempt, in the bench press and leg press in kg)	At baseline and after 13 and 26 weeks of intervention
Other	Nutritional intake	Will be assessed by validated questionnaires such as food diary. Macronutrients composition will be measured from the self-reported nutritional intake: kcal daily intake, protein intake (in gr and in %of total kcal), carbohydrate intake (in gr and in %of total kcal) and fat intake (in gr and in %of total kcal).	At baseline and after 13 and 26 weeks of intervention
Other	Aerobic fitness - Cardio pulmonary exercise testing	Measurement of submaximal aerobic capacity will be assessed by oxygen consumption (indirect calorimetry) performed on a cycling ergometer, with VO2 reported in ml/kg/min.	At baseline and after 13 and 26 weeks of intervention
Primary	Muscle mass (cm3)	Changes in thigh muscles volume	At baseline and after 26 weeks of intervention
Primary	Body composition - fat mass	Fat mass (Kg)	At baseline and after 13 and 26 weeks of intervention
Primary	Body composition	Fat free mass (Kg)	At baseline and after 13 and 26 weeks of intervention
Secondary	Microbial composition and changes	16S rRNA profiling	At baseline and after 13 and 26 weeks of intervention
Secondary	Blood measurements - cardiometabolic markers	Cardiometabolic markers: Glucose (mg/dl), lipid profile (total cholesterol in mg/dl, HDL in mg/dl, LDL in mg/dl)	At baseline and after 13 and 26 weeks of intervention
Secondary	Blood measurements - Insulin	Insulin (pmol/L)	At baseline and after 13 and 26 weeks of intervention
Secondary	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)	At baseline and after 13 and 26 weeks of intervention
Secondary	Blood measurements - Inflammatory markers	Interleukin-6 (pg/ml) (IL6)	At baseline and after 13 and 26 weeks of intervention
Secondary	Blood measurements for nutritional status	Markers for nutritional status: Hemoglobin (g/dl), albumin (g/dl)	At baseline and after 13 and 26 weeks of intervention
Secondary	Blood measurements for micronutrients	Ferritin (ng/ml), B12 (ng/ml)	At baseline and after 13 and 26 weeks of intervention
Secondary	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);	At baseline and after 13 and 26 weeks of intervention
Secondary	Blood measurements of adipokines - leptin	Leptin (ng/ml)	At baseline and after 13 and 26 weeks of intervention
Secondary	Blood measurements of adipokines - adiponectin	Adiponectin (µg/ml)	At baseline and after 13 and 26 weeks of intervention
Secondary	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).	At baseline and after 13 and 26 weeks of intervention
Secondary	Bone density changes	Assessed by DEXA scan (T score and g/cm^2)	At baseline and after 13 and 26 weeks of intervention
Secondary	Anthropometric measurements - BMI	Weight (kg) and height (m) will be combined to calculate BMI (kg/m^2)	At baseline and after 13 and 26 weeks of intervention
Secondary	waist circumference as part of Anthropometric measurements	waist circumference (cm)	At baseline and after 13 and 26 weeks of intervention
Secondary	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).	At baseline and after 13 and 26 weeks of intervention
Secondary	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).	At baseline and after 13 and 26 weeks of intervention