Does Participation in a Pre-Operative Physical Activity Program Improve Patient Outcomes and Quality of Life?

NCT03049696 | Unknown

• 1 other identifier: H2016:283
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to determine whether participation in a pre-bariatric surgery physical activity and behavior modification/education program (ENCOURAGEING START) that is tailored to the unique needs of obese bariatric surgery patients, improves physical fitness, surgical outcomes, patient health and quality of life. Short- (one year) and long- (five year) term outcomes will be compared to matched historical controls (1:1) based on age, gender, and body mass index (BMI) from the existing Manitoba Centre for Metabolic and Bariatric Surgery (CMBS) database. Our findings will determine whether a pre-bariatric surgery physical activity and behavior modification/education program results in improve surgical and patient outcomes and inform the development of evidence-based physical activity (PA) guidelines for bariatric surgery patients and improved CMBS program delivery.

Conditions

Obesity; Bariatric Surgery; Roux-En-Y Gastric Bypass; Exercise; Quality of Life

Keywords

Roux-En-Y Gastric Bypass; Bariatric Surgery; Pre-Operative Physical Activity and Education Program; Obesity; Exercise; Behaviour Modification; Surgical Outcomes; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Six Minute Walk Test (6MWT)

  Measures the distance a patient walks, unassisted and at a self-selected pace, in six minutes. A validated measure of physical fitness and a well-established measure of functional capacity. Has been used to measure improvements in functional capacity in pre- and post- bariatric surgery patients.

  Baseline (0 weeks), 8 weeks, 16 weeks, one year.

Secondary Outcomes (32)

• Anthropometric Measurements-1

  Baseline (0 weeks), 8 weeks, 16 weeks, one and five years.

• Anthropometric Measurements-2

  Baseline (0 weeks), 8 weeks, 16 weeks, one and five years.

• Anthropometric Measurements-3

  Baseline (0 weeks), 8 weeks, 16 weeks, one and five years.

• Anthropometric Measurements-4

  Baseline (0 weeks), 8 weeks, 16 weeks, one and five years.

• Anthropometric Measurements-5

  Baseline (0 weeks), 8 weeks, 16 weeks, one and five years.

Study Arms (2)

Control Group (Standard of Care)

NO INTERVENTION

All patients will receive the Centre for Metabolic and Bariatric Surgery (CMBS) standard of care including two to four multidisciplinary visits over six months, exercise counseling (kinesiologist), completion of a the CMBS behavior modification program (Craving ChangeTM), and achievement of lifestyle and dietary modification goals in order to be scheduled for surgery. The standard of care will be used as the control group (n=24). Matched historical controls (1:1) will be selected (based on age, gender, and body mass index) from the existing CMBS database.

Intervention Group-ENCOURAGEING START

EXPERIMENTAL

Intervention group participants (n=24) will receive the standard of care and complete a 16-week supervised physical activity/behaviour modification program at no cost. The first eight weeks of the program involves structured exercise (two per week) and education classes that patients must attend. Progression to a moderate/high-intensity interval program based the patient's capabilities will occur. Participants will also attend education sessions on risk factor reduction, healthy eating, exercise, stress management and promotion of self-managed care. During the second eight week period, participants will be given access to attend drop-in exercise classes or can opt to complete at home exercise. Participants will have an opportunity to meet with the kinesiologist on at least 4 occasions (60 minutes/meeting) for additional physical activity counseling and assistance with overcoming barriers preventing physical activity.

Behavioral: ENCOURAGEING START

Interventions

ENCOURAGEING START BEHAVIORAL

16-week physical activity and behaviour modification/education program. CMBS approved bariatric surgery patients participate in structured, supervised physical activity sessions (2 per week) and behaviour modification-education classes during weeks 1 through 8. During weeks 9 through 16, patients will be given access to attend drop in physical activity sessions or can opt to complete physical activity at home.

Also known as: Physical activity and behaviour modification/education program

Intervention Group-ENCOURAGEING START

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female obese adults (Body Mass Index equal to or greater than 35 and under 55);
• over 18 years old,
• approved for publicly funded Roux-en-Y gastric bypass surgery by the Centre for Metabolic and Bariatric Surgery,
• able to attend the regular training and education sessions of the intervention program.

You may not qualify if:

• Body Mass Index over 55 (super-obese),
• sleeve gastrectomy, and
• the inability to commit to attending the regular training and education sessions of the intervention program.

Sponsors & Collaborators

• University of Manitoba: lead
• Victoria General Hospital Foundation: collaborator

Study Sites (1)

Centre for Metabolic and Bariatric Surgery (CMBS)

Winnipeg, Manitoba, R3T 2EB, Canada

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise; Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Krista M Hardy, MD, MSC, FRCSC, FACS

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Control Group: Publically funded bariatric surgery program administered through the Centre for Bariatric and Metabolic Surgery (CMBS).; Matched control group Intervention Group: CMBS Program standard of care plus the ENCOURAGING START Program (University of Manitoba Active Living Centre)

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: February 10, 2017
• Study Start: October 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)