Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Conventional" group | Experimental |
| |
| "Combined" group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional rehabilitation program (including concentric cycle ergometer) | Other |
| ||
| cycling included into a conventional rehabilitation program |
| Measure | Description | Time Frame |
|---|---|---|
| For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force | 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) | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| For CAD patients: Functional Independence Measure | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks | |
| For CAD patients: Timed up and go test | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
Not provided
Inclusion Criteria:
Healthy volunteers:
Patients with CAD:
Patients with Chronic obstructive pulmonary disease:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de BESANCON | Besançon | 25000 | France | |||
| CHU de DIJON |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| For CAD patients: Step test with gas exchange measurement | 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 | 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 | 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 | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For CAD patients: heart rate and systolic blood pressure | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For CAD patients: cardiac output measured non-invasively | 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 | 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 | 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 | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For CAD patients: Measurement of lactates | 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 | 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 | 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 | 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) | 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 | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For COPD patients: arterial compliance (pulse wave velocity measurement) | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For COPD patients: Measurement of lactates | 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) | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For COPD patients: St George's Respiratory Questionnaire (SGRQ) | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For COPD patients: Quality of life-BPCO (VQ11) | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For COPD patients: COPD Assessment Test (CAT) | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| For COPD patients: BDI/TDI and mMRC dyspnea assessment | Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks |
| Dijon |
| 21079 |
| France |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided