Physical Activity Counseling After Bariatric Surgery

Study Overview
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Brief Summary
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This study will examine whether providing physical activity counseling and guidance to patients post bariatric surgery, along with long-term personal follow-up for six months after the surgery, may increase the level of physical activity, and it's effect on anthropometric and functional measures.

Detailed Description
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Bariatric surgery is considered to be most effective in treating morbid obesity for patients with BMI≥40 or BMI≥35 with comorbidity for obesity. postoperative weight loss following any type of bariatric surgery is largely dependent on the extent to which patients can make and sustain changes in their eating habits and activity level. Adopting physical activity habits can help to optimize outcomes after bariatric surgery, such as contributing to the rate of weight loss after the surgery and maintain lean body mass. In order to successfully implement a behavioral change regarding the adaptation of healthy lifestyle habits in obese patients, it is vital to promote physical activity counseling after the surgery, and to find an effective intervention that can support habitual physical activity. The aim of this trial is to examine the effect physical activity counseling after bariatric surgery on the amount and intensity of activity performed, quality of life, anthropometric and functional measures during the first year after surgery. Up to eighty Participants will be recruited for the trial, and will be randomly assigned to one of the two study arms (Control, Intervention). The intervention group will receive physical activity counseling and guidelines for the following six months after the surgery. All participants will receive a pedometer to track daily steps for 7 days at different time points before and after the intervention. Additional Measurements will be taken at a pre-surgical baseline assessment and throughout the trial, and will include anthropometric measures (Weight, BMI, and body composition) and functional measures (Handgrip, 6-minute walk test, chair stand-up test). All participants will fill out a the 7-day international Physical Activity questionnaire, Self-efficacy for physical exercise scale, and SF-36 questionnaire, before and after the intervention.

Official Title
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Effects of Physical Activity Counseling After Bariatric Surgery on the Level of Activity and Anthropometric Measures

Conditions
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Obese, Quality of Life, Exercise, Behavior, Health, Bariatric Surgery

Intervention / Treatment
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* Behavioral: Physical Activity counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 40 kg/m2 or 35 kg/m2 with comorbidities 18 to 50 Years old Patient is suitable according to the pre-operative evaluation standards to undergo Bariatric surgery Speaks Hebrew/Arabic fluently Exclusion Criteria: Cognitive decline or severe psychiatric or mental illness Patient undergone bariatric surgery in the past Pregnancy or Breastfeeding Orthopedic disease that limits training and mobility (such as severe arthritis, injury or fractures) Heart disease with a risk to exercise (heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndrome) Moderate /severe lung disease or COPD with FEV1 / FVC <70% on a pulmonary function test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group will receive Physical activity counseling and guidance by a certified Nurse during the six months after the surgery, additional to the routine follow-up after bariatric surgery at Hadassah-Ein Kerem Hospital. | Behavioral: Physical Activity counseling<br>* The Physical activity counseling techniques will be based on the Self Determination Theory and Five A's (Assess, Advise, Agree, Assist, Arrange). Guidelines for physical activity will include combined aerobic and resistance exercises. Each participant in the intervention group will receive personal exercise prescriptions in accordance the post-surgical statues and exercise recommendations after bariatric surgery. Participants will receive long term follow-up and accompaniment during the first six months after the surgery, through Personal meetings with a certified nurse, Phone-calls, motivational massages, and Exercise Videos.<br>|
| No Intervention: Control<br>The control group will receive the routine follow-up followed at Hadassah-Ein Kerem Hospital after bariatric surgery, which includes long term follow-up with the surgeon and a dietitian. Participants at the Control group will receive Physical activity counseling by a certified nurse at the end of trial. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily Step count | Average daily step count of the last 7 days before each visit | change from Baseline at up to 26 weeks (end of the intervention phase) | 
| Average daily Step count | Average daily step count of the last 7 days before each visit | 1 year post-surgery | 
| MET's of Self-reported physical activity | Physical activity score in MET's from self-reported International Physical Activity Questionnaire (IPAQ-sf). Score will be categorized to low, moderate and high intensity level of physical activity. | Change from Baseline at up to 26 weeks (end of the intervention phase) | 
| MET's of Self-reported physical activity | Physical activity score in MET's from self-reported International Physical Activity Questionnaire (IPAQ-sf). Score will be categorized to low, moderate and high intensity level of physical activity. | 1 year post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BMI | weight and height will be combined to report BMI in kg/m^2 | Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery | 
| Changes in Muscle Mass | Measuring Muscle mass using bioelectrical impedance analysis scale | Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery | 
| six min walk test | to measure physical funtion,6 min walk test will be assessed in meters | Change from Baseline at up to 26 weeks (end of the intervention phase) | 
| sit to stand test | test measuring time of 5 repetitions to assesses functional lower extremity strength | Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery | 
| Changes in Handgrip strength test (Kg) | to measure the maximum isometric strength of the hand and forearm muscle in KG | Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery | 
| changes in Self-efficacy assessed by (SSE)- Self-efficacy for physical exercise scale | Self-efficacy score reported in Self-efficacy for physical exercise scale (score 0-90) | Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery | 
| Changes in Health-related Quality of life assessed by SF-36 Questionnaire | reported in Sf-36 Questionnaire | Change from Baseline at up to 26 weeks (end of the intervention phase) | 
| Change in total cholesterol, HDL and LDL levels | Results of bloods tests taken at follow-up | Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery | 
| Change in glucose and HbA1c levels | Results of bloods tests taken at follow-up | Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Exercise