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

July 19, 2019 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • CHU de Besançon
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: "Conventional" group
Other: conventional rehabilitation program (including concentric cycle ergometer)
Experimental: "Combined" group
Other: cycling included into a conventional rehabilitation program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
For CAD patients: Functional Independence Measure
Time Frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASILLAS DB 2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings