Physical Activity Counseling After Bariatric Surgery
- Conditions
- ExerciseBehavior, HealthObeseQuality of LifeBariatric Surgery
- Interventions
- Behavioral: Physical Activity counseling
- Registration Number
- NCT04795375
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Physical Activity counseling 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.
- Primary Outcome Measures
Name Time Method MET's of Self-reported physical activity 1 year post-surgery 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.
Average daily Step count 1 year post-surgery Average daily step count of the last 7 days before each visit
- Secondary Outcome Measures
Name Time Method six min walk test Change from Baseline at up to 26 weeks (end of the intervention phase) to measure physical funtion,6 min walk test will be assessed in meters
sit to stand test Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery test measuring time of 5 repetitions to assesses functional lower extremity strength
Changes in Health-related Quality of life assessed by SF-36 Questionnaire Change from Baseline at up to 26 weeks (end of the intervention phase) reported in Sf-36 Questionnaire
Changes in BMI Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery weight and height will be combined to report BMI in kg/m\^2
Changes in Handgrip strength test (Kg) Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery to measure the maximum isometric strength of the hand and forearm muscle in KG
changes in Self-efficacy assessed by (SSE)- Self-efficacy for physical exercise scale Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery Self-efficacy score reported in Self-efficacy for physical exercise scale (score 0-90)
Changes in Muscle Mass Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery Measuring Muscle mass using bioelectrical impedance analysis scale
Change in glucose and HbA1c levels Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery Results of bloods tests taken at follow-up
Change in total cholesterol, HDL and LDL levels Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery Results of bloods tests taken at follow-up
Trial Locations
- Locations (1)
Hadassah Ein Kerem Medical Center
🇮🇱Jerusalem, Israel