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

Primary Purpose

Readaptation to Effort, Coronaropathy, Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

conventional rehabilitation program (including concentric cycle ergometer)

cycling included into a conventional rehabilitation program

About this trial

This is an interventional other trial for Readaptation to Effort

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

CHU de BESANCON
CHU de DIJON

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

"Conventional" group

"Combined" group

Arm Description

Outcomes

Primary Outcome Measures

For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force

For COPD patients : Endurance time at 75 % of peak workload achieved on a cycle ergometer during the initial concentric cardiopulmonary exercise test (CPET)

Secondary Outcome Measures

For CAD patients: Functional Independence Measure

For CAD patients: Timed up and go test

For CAD patients: Step test with gas exchange measurement

For CAD patients: Distance covered in the 6-minute walk test

For CAD patients: peak VO2 and 1st ventilation adaptation threshold

For CAD patients: VO2 measurement during the 6 minute walk test

For CAD patients: heart rate and systolic blood pressure

For CAD patients: cardiac output measured non-invasively

For CAD patients: maximum isometric muscle strength of the triceps and quadriceps

For CAD patients: tissue oxygenation measured by infrared spectroscopy (non-invasive) at the quadriceps

For CAD patients: reaction hyperaemia in the circumflex humeral artery mesured by ultrasound

For CAD patients: Measurement of lactates

For COPD patients: Distance covered in the 6-minute walk test

For COPD patients: peak VO2 and 1st ventilation adaptation threshold

For COPD patients: SpO2 and heart rate measurement before, during and after the 6-minute walk test

For COPD patients: SpO2 measurement and heart rate during the sessions (warm-up, end of session)

For COPD patients: maximum isometric muscle strength of the quadriceps

For COPD patients: arterial compliance (pulse wave velocity measurement)

For COPD patients: Measurement of lactates

For COPD patients: muscle composition and vascularization through muscle biopsies (optional)

For COPD patients: St George's Respiratory Questionnaire (SGRQ)

For COPD patients: Quality of life-BPCO (VQ11)

For COPD patients: COPD Assessment Test (CAT)

For COPD patients: BDI/TDI and mMRC dyspnea assessment

Full Information

NCT ID

NCT02156245

First Posted

March 5, 2014

Last Updated

July 19, 2019

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT02156245

Brief Title

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

Acronym

ENERGETIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

September 16, 2013 (Actual)

Primary Completion Date

April 3, 2019 (Actual)

Study Completion Date

April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Readaptation to Effort, Coronaropathy, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

212 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"Conventional" group

Arm Type

Experimental

Arm Title

"Combined" group

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

conventional rehabilitation program (including concentric cycle ergometer)

Intervention Type

Other

Intervention Name(s)

cycling included into a conventional rehabilitation program

Primary Outcome Measure Information:

Title

For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force

Time Frame