Prebariatric Surgery Physical Exercise Training in Telehealth (TelePreSET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT02083913
First received: March 4, 2014
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

The aim of our study is to evaluate the feasibility of a supervised training session using telehealth in the "Clinique medico-chirurgicale du traitement de l'obésité de Sherbrooke" (CMCTO) and its impact on health, physical fitness, quality of life and satisfaction of subjects. 6 subjects awaiting bariatric surgery will be recruited. In addition to usual care, subjects will perform additional sessions of supervised endurance and resistance exercise training. Subjects will be instructed to perform two supervised exercise sessions per week with telehealth plus one without supervision during 12 weeks. The following outcomes will be assessed before and after the telePreSET, then 12 months after bariatric surgery: 1- physical fitness (6MWT, maximal strength, symptom-limited cardiac exercise test); 2-health related quality of life (Laval questionnaire); 3-weight, height, body composition (bioelectrical impedance scale); 4-comorbidities and metabolic parameters (files and blood samples); 5-exercise beliefs (Physical Exercise Belief questionnaire); 6-physical activity (GPAQuestionnaire and actimeter). The feasibility will be assessed with a satisfaction questionnaire concerning physical activity management, dropout and compliance rates, as well as the number of injuries and accidents. The results of this research will give us preliminary data for future projects in order to improve support of bariatric surgery candidates to assure optimal results for their health. Also, we will contribute to the advancement of scientific knowledge, absent in the current literature in this population.


Condition Intervention
Obesity
Behavioral: Telehealth supervised exercise training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility and Impacts of a Prebariatric Surgery Exercise Training in Telehealth: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Changes in physical fitness [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ] [ Designated as safety issue: No ]
    6-minutes walking test distance (meter) treadmill symptom-limited cardiac exercise test (METs)


Secondary Outcome Measures:
  • Changes in quality of life scores [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ] [ Designated as safety issue: No ]
    Laval questionnaire

  • Changes in energy expenditure [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ] [ Designated as safety issue: No ]
    Frequency of subjects reaching 150 min of moderate physical activity Total energy expenditure (kcal per day) Number of steps With accelerometer and international physical activity questionnaire

  • Changes in weight (kg) [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ] [ Designated as safety issue: No ]
  • Changes in exercise beliefs [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ] [ Designated as safety issue: No ]
    Exercise beliefs questionnaire: embarrassement, fear of injury, confidence, beliefs in physical activity benefits

  • Final satisfaction [ Time Frame: 12 weeks after exercise training ] [ Designated as safety issue: No ]
    Heath care satisfaction questionnaire (% of subjects satisfied + mean score) TeleHeath care satisfaction questionnaire (% of subjects satisfied + mean score)

  • Changes in body composition [ Time Frame: aseline, then 12 weeks after exercise training and one year after surgery ] [ Designated as safety issue: No ]
    % of fat mass and fat free mass (bioimpedancemeter)

  • Changes in comorbidities [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ] [ Designated as safety issue: No ]
    Medical charts: % of subjects with diabetes, hypertension, dyslipidemia, sleep apnea, depression, anxiety, arthrosis, osteoarthrosis

  • Final compliance [ Time Frame: 12 weeks after the beginning of the intervention ] [ Designated as safety issue: No ]
    Adherence of sessions Number of injuries or adverse events


Estimated Enrollment: 6
Study Start Date: February 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervised physical activity Behavioral: Telehealth supervised exercise training
Endurance and strength training (3x/week during 12 weeks)

Detailed Description:

Background: Obesity class II and III increased most rapidly over the past 25 years in Canada and USA. This alarming situation has significantly increased the number of bariatric surgeries performed in North America (101,645 surgeries in 2011). Indeed, bariatric surgery has demonstrated its long-term efficacy in maintaining significant weight loss and in lowering mortality, while reducing the health-care costs of obesity. Unfortunately, bariatric surgery does not always present optimal results in terms of weight loss and resolution of comorbidities, and may be the cause of perioperative complications. The effectiveness of bariatric surgery and the number of perioperative complications are influenced by various factors such as initial weight or physical fitness/activity. For this reasons, various experts recommend regular physical activity in order to optimize the results of bariatric surgery and to decrease perioperative morbidity. However, no interventional studies including pre-surgery exercise training is available in the literature. Preliminary results showed that a supervised Pre-Surgical Exercise Training (PreSET) is feasible and improved physical fitness and quality of life and decreased embarrassment during exercise (Baillot et al. 2013). However, 71.3 % (n = 57) of patients who refused to participate in PreSET explain their refusal because of their schedule, reduced mobility or distance from the hospital. Telehealth is growing and often used for the rehabilitation of cardiac and pulmonary patients. Indeed, it allows to provide equal access to care for people who are geographically remote and are physically and economically disadvantaged. Studies showed that telehealth improve the quality of health care, and may be as effective as face to face meetings to improve the health of patients. The recent decrease in costs related to the equipment makes this intervention modality more accessible. However, no study is available in subjects awaiting bariatric surgery.

Hypothesis and Objectives: Investigators hypothesize that a Telehealth Pre-Surgical Exercise Training (telePreSET) is feasible and will improve the health, physical fitness, quality of life, compliance and satisfaction of subjects. The aim of our study is to evaluate the feasibility in the "Clinique medico-chirurgicale du traitement de l'obésité de Sherbrooke" (CMCTO) of the telePreSET and its impact on health, physical fitness, quality of life and satisfaction of subjects.

Method: 6 subjects awaiting bariatric surgery will be recruited. In addition to usual care, subjects will perform before bariatric surgery additional sessions of supervised endurance and resistance exercise training. Subjects will be instructed to perform two supervised exercise sessions per week with telehealth plus one without supervision during 12 weeks. The following outcomes will be assessed in the different groups before and after the telePreSET, then 12 months after bariatric surgery: 1- physical fitness (6MWT, maximal strength, symptom-limited cardiac exercise test); 2-health related quality of life (Laval questionnaire); 3-weight, height, body composition (bioelectrical impedance scale); 4-comorbidities and metabolic parameters (files and blood samples); 5-exercise beliefs (Physical Exercise Belief questionnaire); 6-physical activity (GPA Questionnaire and actimeter). The feasibility will be assessed with a satisfaction questionnaire concerning PA management, dropout and compliance rates, as well as the number of injuries and accidents.

Issue: The results of this research will give us preliminary data for future projects in order to improve support for bariatric surgery candidates to assure optimal results for their health. Also, we will contribute to the advancement of scientific knowledge, absent in the current literature in this population.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bariatric surgery candidate : morbid obesity (BMI>40)or severe obesity (BMI>35 with complications; > 18 years old)
  • follow usual care in the "Clinique médico-chirurgicale du traitement de l'obésité du Centre Hospitalier Universitaire de Sherbrooke (CHUS)" and ready to do pre-surgery evaluation (approximately 3 month before surgery)
  • no more than one supervised exercise training per week
  • inability to come regularly to the CHUS to participate in supervised exercise training
  • sufficient space to train at home (4m2)

Exclusion Criteria:

  • medical contraindication for physical activity
  • major functional limitations: failure to realize the 6 minutes walking test
  • intellectual disability and / or neuropsychological disease
  • not being able to speak or understand french
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083913

Contacts
Contact: Marie-France Langlois, MD 819-564-5241 marie-france.langlois@usherbrooke.ca
Contact: Christine Brown 819-346-1110 ext 12846 cbrown.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Marie-France Langlois, MD    819-564-5241    marie-france.langlois@usherbrooke.ca   
Contact: Christine Brown    819-346-1110    cbrown.chus@ssss.gouv.qc.ca   
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Marie-France Langlois, MD Université de Sherbrooke
  More Information

Publications:
Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02083913     History of Changes
Other Study ID Numbers: 13-209
Study First Received: March 4, 2014
Last Updated: March 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Severely obese
Bariatric surgery
Physical activity
Physical fitness
Telehealth
Quality of life

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014