NCT Number: NCT02156245
Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training
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.
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Notify MeKey information
Conditions
Age range
40 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
CHU de BESANCON, Besançon, France
About this study
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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 %
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)
Exclusion criteria
- 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),
- 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.
Treatment and study plan
cycling included into a conventional rehabilitation program
OtherPrimary outcomes
-
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
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
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire Dijon
Other
Registry information
Acronym: ENERGETIC
Important dates
- Study start
- 2013
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jun 5, 2014
- Registry last updated
- Jul 22, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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