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

NCT02156245 | Completed

• 1 other identifier: CASILLAS DB 2011
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

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.

Conditions

Readaptation to Effort; Coronaropathy; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• 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

Study Arms (2)

"Conventional" group

EXPERIMENTAL

Other: conventional rehabilitation program (including concentric cycle ergometer)

"Combined" group

EXPERIMENTAL

Other: cycling included into a conventional rehabilitation program

Interventions

conventional rehabilitation program (including concentric cycle ergometer) OTHER

"Conventional" group

cycling included into a conventional rehabilitation program OTHER

"Combined" group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (2)

CHU de BESANCON

Besançon, 25000, France

Location

CHU de DIJON

Dijon, 21079, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: June 5, 2014
• Study Start: September 16, 2013
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

FR (2)