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

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: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Coronaropathy; Readaptation to Effort
• Intervention / Treatment: Other: conventional rehabilitation program (including concentric cycle ergometer); Other: cycling included into a conventional rehabilitation program

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: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force	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)	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
For CAD patients: Functional Independence Measure	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Timed up and go test	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Step test with gas exchange measurement	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	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	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	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: heart rate and systolic blood pressure	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: cardiac output measured non-invasively	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	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	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	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For CAD patients: Measurement of lactates	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	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	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	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)	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	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: arterial compliance (pulse wave velocity measurement)	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Measurement of lactates	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)	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: St George's Respiratory Questionnaire (SGRQ)	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: Quality of life-BPCO (VQ11)	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: COPD Assessment Test (CAT)	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For COPD patients: BDI/TDI and mMRC dyspnea assessment	Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2013
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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