Physical Activity Counseling After Bariatric Surgery

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Exercise; Obese; Bariatric Surgery; Behavior, Health
• Intervention / Treatment: Behavioral: Physical Activity counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Ein Kerem Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise
• Other Study ID Numbers: BPA-0965-HMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No