Clinical trial NCT02156245: Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training
Official title: Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Readaptation to Effort
Coronaropathy
Chronic Obstructive Pulmonary Disease
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 212
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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). 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).

Eligibility criteria: 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.

Primary outcomes:
measure: For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients : Endurance time at 75 % of peak workload achieved on a cycle ergometer during the initial concentric cardiopulmonary exercise test (CPET)
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
Secondary outcomes:
measure: For CAD patients: Functional Independence Measure
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: Timed up and go test
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: Step test with gas exchange measurement
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: Distance covered in the 6-minute walk test
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: peak VO2 and 1st ventilation adaptation threshold
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: VO2 measurement during the 6 minute walk test
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: heart rate and systolic blood pressure
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: cardiac output measured non-invasively
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: maximum isometric muscle strength of the triceps and quadriceps
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: tissue oxygenation measured by infrared spectroscopy (non-invasive) at the quadriceps
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: reaction hyperaemia in the circumflex humeral artery mesured by ultrasound
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For CAD patients: Measurement of lactates
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: Distance covered in the 6-minute walk test
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: peak VO2 and 1st ventilation adaptation threshold
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: SpO2 and heart rate measurement before, during and after the 6-minute walk test
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: SpO2 measurement and heart rate during the sessions (warm-up, end of session)
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: maximum isometric muscle strength of the quadriceps
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: arterial compliance (pulse wave velocity measurement)
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: Measurement of lactates
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: muscle composition and vascularization through muscle biopsies (optional)
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: St George's Respiratory Questionnaire (SGRQ)
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: Quality of life-BPCO (VQ11)
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: COPD Assessment Test (CAT)
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
measure: For COPD patients: BDI/TDI and mMRC dyspnea assessment
timeFrame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de BESANCON
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References: