Physical Activity Counseling After Bariatric Surgery

NCT04795375 | Unknown

• 1 other identifier: BPA-0965-HMO
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Physical Activity; Exercise

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Changes in BMI

  Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery

• Changes in Muscle Mass

  Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery

• six min walk test

  Change from Baseline at up to 26 weeks (end of the intervention phase)

• sit to stand test

  Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery

• Changes in Handgrip strength test (Kg)

  Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Physical Activity counseling 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥ 40 kg/m2 or 35 kg/m2 with comorbidities
• to 50 Years old
• Patient is suitable according to the pre-operative evaluation standards to undergo Bariatric surgery
• Speaks Hebrew/Arabic fluently

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Ein Kerem Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Bariatric surgeon Hadassah Ein Kerem

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 12, 2021
• Study Start: March 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: March 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

IL (1)