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

NCT ID: NCT02156245

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-16
• Study Completion Date: 2019-04-03

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).

Conditions

Readaptation to Effort; Coronaropathy; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

"Conventional" group

Group Type: EXPERIMENTAL

conventional rehabilitation program (including concentric cycle ergometer)

Intervention Type: OTHER

"Combined" group

Group Type: EXPERIMENTAL

cycling included into a conventional rehabilitation program

Intervention Type: OTHER

Interventions

conventional rehabilitation program (including concentric cycle ergometer)

Intervention Type: OTHER

cycling included into a conventional rehabilitation program

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de BESANCON

Besançon, , France

CHU de DIJON

Dijon, , France

Countries

France

Other Identifiers

CASILLAS DB 2011

Identifier Type: -

Identifier Source: org_study_id