CompletedNot Applicable

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

France212 participantsStarted 2013-09-16

Plain-language 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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…). * Physi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT02156245

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-03

View on ClinicalTrials.gov More Readaptation to Effort trials

Plain-language summary

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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