Readaptation to EffortENERGETICNCT02156245
Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training
A study testing conventional rehabilitation program (including concentric cycle ergometer) and cycling included into a conventional rehabilitation program in people with Readaptation to Effort and Coronaropathy, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
The aim of this study is to assess the efficacy of a rehabilitation protocol based on individualized combined eccentric and concentric cycle ergometer training compared to classical concentric cycle training among patients with either coronary artery disease (CAD) or chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Readaptation to Effort, Coronaropathy, Chronic Obstructive Pulmonary Disease
- What is being tested?
- conventional rehabilitation program (including concentric cycle ergometer) and cycling included into a conventional rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Sep 2013to 3 Apr 2019
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons who have provided written informed consent
- Healthy volunteers:
- Men or women aged between 40 and 75 years.
- Patients with CAD:
- Men or women aged between 40 and 75 years, with coronary artery disease without heart failure referred for a rehabilitation program.
- Left ventricular ejection fraction on echocardiography (Simpson methode) > 45 %
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- Patients with Chronic obstructive pulmonary disease:
- Men or women aged between 40 and 75 years
- Severe Chronic obstructive pulmonary disease (post-bronchodilatator FEV1/FVC < 0.70 and FEV1 ≤ 60% of predicted value)
- Patient not on oxygen therapy (24h/24)
Who cannot join
- Person without national health insurance cover
- Severe, obstructive cardiopathy
- Severe aortic valve stenosis,
- Severe progressive heart rhythm or conduction disorders not corrected by a pacemaker and detected during the initial effort test
- Cardiac intracavitary thrombus,
- Severe pulmonary artery hypertension (PAHT systolic >70mmHg),
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- Recent history of venous thromboembolism (previous 3 months),
- Impaired executive functions making it impossible to understand and adhere to a rehabilitation program (Mini Mental Test < 24),
- Heart transplant,
- Associated medical condition that could substantially affect functional capacities (examples: non-stabilized metabolic disorders such as progressive renal insufficiency, major asthenia linked to a severe non-stabilized disorder such as neoplasia, systemic disease…).
- Physical incapacity of the lower limbs that could impair rehabilitation, whether they are neurological (central or peripheral), arterial (in particular, peripheral artery disease with a systolic index < 0.6) or orthopedic (degenerative or inflammatory rheumatism).
- Patients who have taken part (within the previous 6 months) or a currently taking part in a rehabilitation program.
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of this study is to assess the efficacy of a rehabilitation protocol based on individualized combined eccentric and concentric cycle ergometer training compared to classical concentric cycle training among patients with either coronary artery disease (CAD) or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the efficacy of combined eccentric/concentric training on physical capacity and overall autonomy, and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and muscular effort and tolerance.
Read the detailed description
The research will take place in 3 phases:
PHASE 1 :
30 healthy volunteers will be included to test tolerance to personalized exercise on an eccentric cycle ergometer.
PHASE 2 :
15 patients suffering from coronary artery disease (CAD) and 15 patients suffering from chronic obstructive pulmonary disease (COPD) will be included to test the same protocol.
PHASE 3 :
A total of 169 patients split into 2 parallel groups will be included: a group receiving conventional rehabilitation (group A) and the other group receiving eccentric exercise combined to conventional rehabilitation (group B).
Coronary patients: 93 patients will be included (62 patients in group A and 31 in group B).
COPD patients: 76 patients will be included (38 patients per group).
- Being tested
- conventional rehabilitation program (including concentric cycle ergometer), cycling included into a conventional rehabilitation program
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional rehabilitation program (including concentric cycle ergometer)Other
cycling included into a conventional rehabilitation programOther
| Study group | Role | What they receive |
|---|---|---|
| "Conventional" group | Experimental | Not described Receives: Other: conventional rehabilitation program (including concentric cycle ergometer) |
| "Combined" group | Experimental | Not described Receives: Other: cycling included into a conventional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients : Endurance time at 75 % of peak workload achieved on a cycle ergometer during the initial concentric cardiopulmonary exercise test (CPET)
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
Secondary outcomes (24)
For CAD patients: Functional Independence Measure
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Timed up and go test
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Step test with gas exchange measurement
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Distance covered in the 6-minute walk test
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: peak VO2 and 1st ventilation adaptation threshold
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: VO2 measurement during the 6 minute walk test
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: heart rate and systolic blood pressure
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: cardiac output measured non-invasively
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: maximum isometric muscle strength of the triceps and quadriceps
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: tissue oxygenation measured by infrared spectroscopy (non-invasive) at the quadriceps
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: reaction hyperaemia in the circumflex humeral artery mesured by ultrasound
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Measurement of lactates
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Distance covered in the 6-minute walk test
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: peak VO2 and 1st ventilation adaptation threshold
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: SpO2 and heart rate measurement before, during and after the 6-minute walk test
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: SpO2 measurement and heart rate during the sessions (warm-up, end of session)
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: maximum isometric muscle strength of the quadriceps
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: arterial compliance (pulse wave velocity measurement)
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Measurement of lactates
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: muscle composition and vascularization through muscle biopsies (optional)
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: St George's Respiratory Questionnaire (SGRQ)
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Quality of life-BPCO (VQ11)
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: COPD Assessment Test (CAT)
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: BDI/TDI and mMRC dyspnea assessment
Measured: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study start16 Sep 2013
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Readaptation to EffortStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156245
- Sponsor's protocol ID
- CASILLAS DB 2011
- Acronym
- ENERGETIC
- Status last verified
- Jul 2019
- First submitted
- 5 Mar 2014
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training
- ClinicalTrials.gov ID
- NCT02156245
- Acronym / sponsor ID
- ENERGETIC / CASILLAS DB 2011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 16 Sep 2013 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 5 Jun 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 this study is to assess the efficacy of a rehabilitation protocol based on individualized combined eccentric and concentric cycle ergometer training compared to classical concentric cycle training among patients with either coronary artery disease (CAD) or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the efficacy of combined eccentric/concentric training on physical capacity and overall autonomy, and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and muscular effort and tolerance.
Detailed description
The research will take place in 3 phases:
PHASE 1 :
30 healthy volunteers will be included to test tolerance to personalized exercise on an eccentric cycle ergometer.
PHASE 2 :
15 patients suffering from coronary artery disease (CAD) and 15 patients suffering from chronic obstructive pulmonary disease (COPD) will be included to test the same protocol.
PHASE 3 :
A total of 169 patients split into 2 parallel groups will be included: a group receiving conventional rehabilitation (group A) and the other group receiving eccentric exercise combined to conventional rehabilitation (group B).
Coronary patients: 93 patients will be included (62 patients in group A and 31 in group B).
COPD patients: 76 patients will be included (38 patients per group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Conventional" group | Experimental | Other: conventional rehabilitation program (including concentric cycle ergometer) |
| "Combined" group | Experimental | Other: cycling included into a conventional rehabilitation program |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Persons who have provided written informed consent
- Men or women aged between 40 and 75 years.
- Men or women aged between 40 and 75 years, with coronary artery disease without heart failure referred for a rehabilitation program.
- Left ventricular ejection fraction on echocardiography (Simpson methode) > 45 %
- Men or women aged between 40 and 75 years
Key exclusion criteria (12 listed)
- Person without national health insurance cover
- Severe, obstructive cardiopathy
- Severe aortic valve stenosis,
- Severe progressive heart rhythm or conduction disorders not corrected by a pacemaker and detected during the initial effort test
- Cardiac intracavitary thrombus,
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 |
|---|---|---|
| conventional rehabilitation program (including concentric cycle ergometer) | Other | "Conventional" group |
| cycling included into a conventional rehabilitation program | Other | "Combined" group |
Primary outcome
For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients : Endurance time at 75 % of peak workload achieved on a cycle ergometer during the initial concentric cardiopulmonary exercise test (CPET)
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
24 secondary outcomes
For CAD patients: Functional Independence Measure
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Timed up and go test
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Step test with gas exchange measurement
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Distance covered in the 6-minute walk test
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: peak VO2 and 1st ventilation adaptation threshold
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: VO2 measurement during the 6 minute walk test
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: heart rate and systolic blood pressure
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: cardiac output measured non-invasively
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: maximum isometric muscle strength of the triceps and quadriceps
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: tissue oxygenation measured by infrared spectroscopy (non-invasive) at the quadriceps
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: reaction hyperaemia in the circumflex humeral artery mesured by ultrasound
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Measurement of lactates
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Distance covered in the 6-minute walk test
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: peak VO2 and 1st ventilation adaptation threshold
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: SpO2 and heart rate measurement before, during and after the 6-minute walk test
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: SpO2 measurement and heart rate during the sessions (warm-up, end of session)
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: maximum isometric muscle strength of the quadriceps
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: arterial compliance (pulse wave velocity measurement)
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Measurement of lactates
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: muscle composition and vascularization through muscle biopsies (optional)
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: St George's Respiratory Questionnaire (SGRQ)
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Quality of life-BPCO (VQ11)
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: COPD Assessment Test (CAT)
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: BDI/TDI and mMRC dyspnea assessment
Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
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 22 Jul 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional rehabilitation program (including concentric cycle ergometer) and cycling included into a conventional rehabilitation program in people with Readaptation to Effort and Coronaropathy, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
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 10 inclusion and 12 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 22 Jul 2019. 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 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?
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?
For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force (time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2019.