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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
212
CHU de BESANCON
Besançon, France
CHU de DIJON
Dijon, France
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
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
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