Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training (ENERGETIC)

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Readaptation to Effort

Coronaropathy

Treatments

Other: conventional rehabilitation program (including concentric cycle ergometer)

Other: cycling included into a conventional rehabilitation program

Study type

Interventional

Funder types

Other

Identifiers

NCT02156245

CASILLAS DB 2011

Details and patient eligibility

About

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.

Full 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).

Enrollment

212 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.