Physical Activity Counseling After Bariatric Surgery

NCT ID: NCT04795375

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-03-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Activity counseling

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Ram Elazary

Head Bariatric surgeon Hadassah Ein Kerem

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah Ein Kerem Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

BPA-0965-HMO

Identifier Type: -

Identifier Source: org_study_id