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Prebariatric Surgery Physical Exercise Training in Telehealth (TelePreSET)

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ClinicalTrials.gov Identifier: NCT02083913
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date October 15, 2018
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Changes in physical fitness [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
6-minutes walking test distance (meter) treadmill symptom-limited cardiac exercise test (METs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
  • Changes in quality of life scores [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
    Laval questionnaire
  • Changes in energy expenditure [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
    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 ]
  • Changes in exercise beliefs [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
    Exercise beliefs questionnaire: embarrassement, fear of injury, confidence, beliefs in physical activity benefits
  • Final satisfaction [ Time Frame: 12 weeks after exercise training ]
    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 ]
    % 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 ]
    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 ]
    Adherence of sessions Number of injuries or adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
  • Changes in quality of life scores [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
    Laval questionnaire
  • Changes in energy expenditure [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
    Frequency of subjects reaching 150 min of moderate physical activity Total energy expenditure (kcal per day) Number of steps With accelerometer and internationnal physical activity questionnaire
  • Changes in weight (kg) [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
  • Changes in exercise beliefs [ Time Frame: baseline, then 12 weeks after exercise training and one year after surgery ]
    Exercise beliefs questionnaire: embarassement, fear of injury, confidence, beliefs in physical activity benefits
  • Final satisfaction [ Time Frame: 12 weeks after exercise training ]
    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 ]
    % of fat mass and fat free mass (bioimpedancemeter)
  • Changes in comorbidites [ Time Frame: aseline, then 12 weeks after exercise training and one year after surgery ]
    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 ]
    Adherence of sessions Number of injuries or adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prebariatric Surgery Physical Exercise Training in Telehealth
Official Title  ICMJE Feasibility and Impacts of a Prebariatric Surgery Exercise Training in Telehealth: a Pilot Study
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Telehealth supervised exercise training
Endurance and strength training (3x/week during 12 weeks)
Study Arms  ICMJE Experimental: Supervised physical activity
Intervention: Behavioral: Telehealth supervised exercise training
Publications * Baillot A, Mampuya WM, Comeau E, Méziat-Burdin A, Langlois MF. Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg. 2013 Jul;23(7):882-91. doi: 10.1007/s11695-013-0875-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2014)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083913
Other Study ID Numbers  ICMJE 13-209
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie-France Langlois, MD Université de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP