ObesityOBEX1NCT01155271
OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training
A study testing Rehabilitation in people with Obesity and Sleep Apnea, run by AGIR à Dom at 2 sites in 2 countries.
Trial summary
The study was designed to test the following hypotheses: In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Sleep Apnea
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2010to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSAS (AHI > 30 before CPAP treatment)
- > 4h/d CPAP treatment adherence
- Obese patients with 35 < BMI < 45 kg/m2
- Patients who give written consent
- Patients who subscribed social insurance
Who cannot join
- Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
- Contraindication to exercise
- Pregnant or breast-feed woman
- Patients under guardianship
- Imprisoned patients
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, GIV 4G5
About this study
Official title: Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study
The study was designed to test the following hypotheses:
In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.
Read more
In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger) in addition to cycloergometer [cycloergometer + spirotiger] will be higher than cycloergometer training alone [cycloergometer] in term of functional and exercise capacities.
Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer + spirotiger]
Read the detailed description
Background: Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. We hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with SAS.
Objective: To evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by CPAP for OSAS (secondary objectives)
Methods: We proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with SAS. After a 6-week control pre-inclusion period, patients are included in either [cycloergometer] vs. [cycloergometer with ventilatory assistance] vs. [cycloergometer + respiratory muscle exercises]. Before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. During the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year.
An interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). The Peto's method will be used to correct the p-values.
- Conditions
- Obesity, Sleep Apnea
- Being tested
- Rehabilitation
- Medical subject headings
- Obesity, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)
1 technical visit and 1 nursing visit every two months at home for the CPAP
| Study group | Role | What they receive |
|---|---|---|
| ERGO | Active comparator | General endurance training on cycloergometer Receives: Other: Rehabilitation |
| ERGONIV/ ERGOSPIRO | Active comparator | General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO) Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise tolerance during walking test
- walking distance
- dyspnea score
Measured: After control period (6th wk) vs. after training period (18th wk)
Secondary outcomes (9)
Changes in Aerobic capacity
Maximal oxygen consumption
Measured: After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in cardiovascular and metabolic function
Pulse wave velocity, peripheral arterial tone, BP, inflammatory and metabolic plasmatic markers
Measured: After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in sleep parameters and Quality Of life
Nocturnal oxygen saturation, CPAP data, Epworth questionnaire, Short Form (36) Health Survey questionnaire
Measured: After control period (6th wk) vs. after training period (18th and 52th wks)
Number of cardiovascular events per year
Questionnaire sent to the patient by mail
Measured: Every year from the 1st to the 5th year
Changes in body composition
Fat mass and fat-mass index Fat-free mass and fat-free mass index assessed by impedancemetry measurements
Measured: After control period (6th wk) vs. after training period (18th and 52th wks)
Change in physical activity and sleep duration
Number of hour per day of physical activity at 1, 2, 3 or 4 Metabolic Equivalents (METS); Number of steps per day; Sleep to lying position duration ratio
Measured: After control period (6th wk) vs. after training period (18th and 52th wks)
Change in exercise tolerance during walking test
- isotime dyspnea
- isotime oxygen saturation
Measured: After control period (6th wk) vs. after trainng (52th wk)
Change in physiological variables during the control period
- functional and exercise parameters
- cardiovascular parameters
- metabolic parameters
- sleep and quality of life parameters (Short Form (36) Health Survey)
- physical activity
Measured: Before (1st) vs. after control period (6th wk)
Baseline characteristics
- functional and exercise parameters
- cardiovascular parameters
- metabolic parameters
- sleep and quality of life parameters (Short Form (36) Health Survey)
- physical activity
Measured: Before control period (1st week) or after the control period (6th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionDec 2018 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pepin, MD, PhD, Principal investigator, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155271
- Sponsor's protocol ID
- AGIR-03
- Acronym
- OBEX1
- Status last verified
- Sep 2018
- First submitted
- 30 Jun 2010
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vivodtzev I, Tamisier R, Croteau M, Borel JC, Grangier A, Wuyam B, Levy P, Minville C, Series F, Maltais F, Pepin JL. Ventilatory support or respiratory muscle training as adjuncts to exercise in obese CPAP-treated patients with obstructive sleep apnoea: a randomised controlled trial. Thorax. 2018 Feb 20:thoraxjnl-2017-211152. doi: 10.1136/thoraxjnl-2017-211152. Online ahead of print.
PubMed 29463621
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01155271
- Acronym / sponsor ID
- OBEX1 / AGIR-03
- Conditions
- Obesity, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Jul 2010 (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 study was designed to test the following hypotheses:
In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.
In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger) in addition to cycloergometer [cycloergometer + spirotiger] will be higher than cycloergometer training alone [cycloergometer] in term of functional and exercise capacities.
Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer + spirotiger]
Detailed description
Background: Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. We hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with SAS.
Objective: To evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by CPAP for OSAS (secondary objectives)
Methods: We proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with SAS. After a 6-week control pre-inclusion period, patients are included in either [cycloergometer] vs. [cycloergometer with ventilatory assistance] vs. [cycloergometer + respiratory muscle exercises]. Before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. During the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year.
An interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). The Peto's method will be used to correct the p-values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERGO | Active comparator | Other: RehabilitationGeneral endurance training on cycloergometer |
| ERGONIV/ ERGOSPIRO | Active comparator | Other: RehabilitationGeneral endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- OSAS (AHI > 30 before CPAP treatment)
- > 4h/d CPAP treatment adherence
- Obese patients with 35 < BMI < 45 kg/m2
- Patients who give written consent
- Patients who subscribed social insurance
Key exclusion criteria (5 listed)
- Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
- Contraindication to exercise
- Pregnant or breast-feed woman
- Patients under guardianship
- Imprisoned patients
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 |
|---|---|---|
| Rehabilitation12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home) 1 technical visit and 1 nursing visit every two months at home for the CPAP | Other | ERGO, ERGONIV/ ERGOSPIRO |
Primary outcome
Change in exercise tolerance during walking test
Time frame: After control period (6th wk) vs. after training period (18th wk)
* walking distance * dyspnea score
9 secondary outcomes
Changes in Aerobic capacity
Time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in cardiovascular and metabolic function
Time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in sleep parameters and Quality Of life
Time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Number of cardiovascular events per year
Time frame: Every year from the 1st to the 5th year
Changes in body composition
Time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Change in physical activity and sleep duration
Time frame: After control period (6th wk) vs. after training period (18th and 52th wks)
Change in exercise tolerance during walking test
Time frame: After control period (6th wk) vs. after trainng (52th wk)
Change in physiological variables during the control period
Time frame: Before (1st) vs. after control period (6th wk)
Baseline characteristics
Time frame: Before control period (1st week) or after the control period (6th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Derived from this study: PubMed 29463621Vivodtzev I, Tamisier R, Croteau M, Borel JC, Grangier A, Wuyam B, Levy P, Minville C, Series F, Maltais F, Pepin JL. Ventilatory support or respiratory muscle training as adjuncts to exercise in obese CPAP-treated patients with obstructive sleep apnoea: a randomised controlled trial. Thorax. 2018 Feb 20:thoraxjnl-2017-211152. doi: 10.1136/thoraxjnl-2017-211152. Online ahead of print.
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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.
Jean-Louis Pepin, MD, PhD principal investigator
Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Obesity and Sleep Apnea, run by AGIR à Dom at 2 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 2 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 2 sites in Canada, France. 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?
Results are not available in the source record.
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?
Change in exercise tolerance during walking test (time frame: After control period (6th wk) vs. after training period (18th wk)). 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 NCT01155271, 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 2 Oct 2018.