Physical Activity Counseling After Bariatric Surgery

Hadassah Medical Center

Status: Unknown

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

Treatments: Behavioral: Physical Activity counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04795375

BPA-0965-HMO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity counseling

Control

No Intervention group

Description:

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.