Physical Activity Counseling After Bariatric Surgery

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04795375
• Other study ID #: BPA-0965-HMO
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2022
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: March 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Physical 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.

Locations

Country	Name	City	State
Israel	Hadassah Ein Kerem Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Average daily Step count	Average daily step count of the last 7 days before each visit	1 year post-surgery
Primary	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)
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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