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ObesityTelePreSETNCT02083913

Prebariatric Surgery Physical Exercise Training in Telehealth

A study testing Telehealth supervised exercise training in people with Obesity, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Telehealth supervised exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
Feb 2014to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: Feasibility and Impacts of a Prebariatric Surgery Exercise Training in Telehealth: a Pilot Study

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.

Read the 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.

Conditions
Obesity
Being tested
Telehealth supervised exercise training
Keywords
Severely obese, Bariatric surgery, Physical activity, Physical fitness, Telehealth, Quality of life
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehealth supervised exercise trainingBehavioural

    Endurance and strength training (3x/week during 12 weeks)

Study groups in NCT02083913
Study groupRoleWhat they receive
Supervised physical activityExperimentalNot described
Receives: Behavioral: Telehealth supervised exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in physical fitness

    6-minutes walking test distance (meter) treadmill symptom-limited cardiac exercise test (METs)

    Measured: baseline, then 12 weeks after exercise training and one year after surgery

Secondary outcomes (8)
  1. Changes in quality of life scores

    Laval questionnaire

    Measured: baseline, then 12 weeks after exercise training and one year after surgery

  2. Changes in energy expenditure

    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

    Measured: baseline, then 12 weeks after exercise training and one year after surgery

  3. Changes in weight (kg)

    Measured: baseline, then 12 weeks after exercise training and one year after surgery

  4. Changes in exercise beliefs

    Exercise beliefs questionnaire: embarrassement, fear of injury, confidence, beliefs in physical activity benefits

    Measured: baseline, then 12 weeks after exercise training and one year after surgery

  5. Final satisfaction

    Heath care satisfaction questionnaire (% of subjects satisfied + mean score) TeleHeath care satisfaction questionnaire (% of subjects satisfied + mean score)

    Measured: 12 weeks after exercise training

  6. Changes in body composition

    % of fat mass and fat free mass (bioimpedancemeter)

    Measured: aseline, then 12 weeks after exercise training and one year after surgery

  7. Changes in comorbidities

    Medical charts: % of subjects with diabetes, hypertension, dyslipidemia, sleep apnea, depression, anxiety, arthrosis, osteoarthrosis

    Measured: baseline, then 12 weeks after exercise training and one year after surgery

  8. Final compliance

    Adherence of sessions Number of injuries or adverse events

    Measured: 12 weeks after the beginning of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02083913
Sponsor's protocol ID
13-209
Acronym
TelePreSET
Status last verified
Oct 2017
First submitted
4 Mar 2014
Last updated
15 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Baillot A, Mampuya WM, Comeau E, Meziat-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.

    PubMed 23430477

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth supervised exercise training in people with Obesity, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in physical fitness (time frame: baseline, then 12 weeks after exercise training and one year after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02083913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.

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