Bariatric Surgery, Behavior, Health, Exercise, Obese, Quality of Life
Conditions
Keywords
Physical Activity, Exercise
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.
Interventions
BEHAVIORALPhysical Activity counseling
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.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average daily Step count | change from Baseline at up to 26 weeks (end of the intervention phase) | Average daily step count of the last 7 days before each visit |
| MET's of Self-reported physical activity | Change from Baseline at up to 26 weeks (end of the intervention phase) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| 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 |
| 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 |
| 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 |
Countries
Israel
Outcome results
None listed