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Completed

NCT Number: NCT02156245

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de BESANCON, Besançon, France

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional rehabilitation program (including concentric cycle ergometer)

Other

cycling included into a conventional rehabilitation program

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. For CAD patients: Functional Independence Measure

    Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. For CAD patients: Measurement of lactates

    Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. For COPD patients: Measurement of lactates

    Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

  20. 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

  21. 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

  22. 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

  23. For COPD patients: COPD Assessment Test (CAT)

    Time frame: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks

  24. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ENERGETIC

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2014
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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