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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Supervised physical activity | Experimental | Not described Receives: Behavioral: Telehealth supervised exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Changes in quality of life scores
Laval questionnaire
Measured: baseline, then 12 weeks after exercise training and one year after surgery
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
Changes in weight (kg)
Measured: baseline, then 12 weeks after exercise training and one year after surgery
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
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
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
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
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.
- First posted11 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-France Langlois, MD, Principal investigator, Université de Sherbrooke
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impacts of a Prebariatric Surgery Exercise Training in Telehealth: a Pilot Study
- ClinicalTrials.gov ID
- NCT02083913
- Acronym / sponsor ID
- TelePreSET / 13-209
- Conditions
- Obesity
- Keywords
- Severely obese, Bariatric surgery, Physical activity, Physical fitness, Telehealth, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supervised physical activity | Experimental | Behavioral: Telehealth supervised exercise training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth supervised exercise trainingEndurance and strength training (3x/week during 12 weeks) | Behavioural | Supervised physical activity |
Primary outcome
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)
8 secondary outcomes
Changes in quality of life scores
Time frame: baseline, then 12 weeks after exercise training and one year after surgery
Changes in energy expenditure
Time frame: baseline, then 12 weeks after exercise training and one year after surgery
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
Final satisfaction
Time frame: 12 weeks after exercise training
Changes in body composition
Time frame: aseline, then 12 weeks after exercise training and one year after surgery
Changes in comorbidities
Time frame: baseline, then 12 weeks after exercise training and one year after surgery
Final compliance
Time frame: 12 weeks after the beginning of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 23430477Baillot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-France Langlois, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
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.