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Rehabilitation by Eccentric Exercise in Heart Failure Patients (REX-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716778
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Clinique Médicale Cardio-Pneumologique de Durtol
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

As part of the regular rehabilitation program for chronic heart failure (CHF) patients, the addition of dynamic eccentric endurance (ECC) exercise sessions to the conventional concentric cycling program (CON) would enable greater gains in functional capacity that the CON alone. Furthermore, in the case of severe heart failure, results of conventional exercise rehabilitation remains limited on account of the poor physical fitness and deconditioning. Dynamic ECC has been shown to enhance muscle mass and improve muscle strength in subjects with functional limitations comparable to those in CHF, but to date reports on effects on muscle endurance and overall functional capacity remain scarce or non-existent.

Investigator hypothesize that a combination of these two types of training will allow both an improvement in strength and oxidative muscle capacities. These benefits must be objectified at the level of the walking distance covered in 6 min (6-WT).


Condition or disease Intervention/treatment Phase
Chronic Heart Failure Patient Rehabilitation Program Other: Eccentric rehabilitation sessions Not Applicable

Detailed Description:

Investigator hypothesize that the combination of CON and ECC forms of endurance exercise will potentiate peripheral muscle and cardio-circulatory adaptations. All sessions, regardless of the modality, will be performed at the same percentage of the concentric peakVO2. Sessions performed in ECC mode will induce a mechanical overload. The ECC training of such intensity and duration seemingly having little or no effect on mitochondrial muscle adaptations, the maintenance of conventional training will allow stimulation of the aerobic endurance component. A synergistic effect is expected from the combination of the two modalities; the muscle strength gain induced by ECC allowing to sustained greater cycling workloads yet compatible with the cardio-circulatory capabilities of patients with CHF and more specifically their exercise cardiac output adjustment.

Investigator chose to assess the extent of benefits through functional capacity tests reflecting adaptation of both the aerobic (endurance capacity) and anaerobic (muscle strength) components of adaptive response, namely, 1) 6 min. walk test (6-WT), 2) time up and go test (TUGT), 3) quadriceps isometric muscular strength (IMS) and gait speed test.

The study is a prospective, open, controlled and randomized study in two parallel groups carried out in a single center. Patients will be included in the study if: i) they are referred to the cardiac rehabilitation center for the 5-week training program, ii) they meet the inclusion criteria and iii) they provide their signed consent.

Patients will be followed for 5 weeks, the duration of the cardiac rehabilitation program. They will benefit from the standard evaluation of any CHF patient referred for rehabilitation including an initial 12-lead ECG, a trans-thoracic cardiac ultrasound assessment and a cycling exercise stress test with gas exchange analysis and non-invasive measurement of cardiac output using a bio-impedance device. A standard biological blood analysis will be performed for NFS-platelets, blood electrolytes, CRP, NTproBNP, nutritional status with albumin and pre-albumin.

All subjects will perform 5 exercise sessions per week on a cycle ergometer. As per randomization outcome, the "intervention" group will perform three of the five weekly sessions in ECC mode (the other two in CON) while the control group will perform the five weekly sessions in CON mode.

The intensity of the cycling will be the same in both groups as determined from the initial cycling incremental test targeted to correspond to the VO2 associated with the ventilatory threshold.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Enhanced Effectiveness of Combined Eccentric and Concentric Exercise Over Traditional Cardiac Exercise Rehabilitation Program in Patients With Chronic Heart Failure: a Randomized Controlled Study
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Classical exercise training modality in concentric mode (CON)
Description: Control group, usual medical care according to the rehabilitation recommendations
Other: Eccentric rehabilitation sessions

ECC cycling will be conducted using a commercially available ECC motor-driven ergometer. Intensity and duration are progressively increased during the first five sessions in order to minimize the extent of exercise-induced muscle soreness.

The subjects will perform five sessions of endurance training on cycle ergometer per week. Each session lasting 30 minutes will be achieved at an intensity corresponding to the pre-determined CON ventilatory threshold. In the ECC group, 3 sessions of ECC (Monday, Wednesday and Friday) and two session of concentric (Tuesday and Thursday) cycling will be carried out each week. In the control group CON all sessions will be achieved using the traditional pedaling mode.


Experimental: experimental, active group (ECC)
Patients perform a mixed program combining eccentric pedalling session with the usual sessions
Other: Eccentric rehabilitation sessions

ECC cycling will be conducted using a commercially available ECC motor-driven ergometer. Intensity and duration are progressively increased during the first five sessions in order to minimize the extent of exercise-induced muscle soreness.

The subjects will perform five sessions of endurance training on cycle ergometer per week. Each session lasting 30 minutes will be achieved at an intensity corresponding to the pre-determined CON ventilatory threshold. In the ECC group, 3 sessions of ECC (Monday, Wednesday and Friday) and two session of concentric (Tuesday and Thursday) cycling will be carried out each week. In the control group CON all sessions will be achieved using the traditional pedaling mode.





Primary Outcome Measures :
  1. 6 min. walk test (6-WT) [ Time Frame: at day 1 ]
    6 min. walk test (6-WT)

  2. 6 min. walk test (6-WT) [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    6 min. walk test (6-WT)


Secondary Outcome Measures :
  1. Time up and go test (TUGT) [ Time Frame: at day 1 ]
    Test that evaluates seated transfers, standing, walking and changes of direction.

  2. Time up and go test (TUGT) [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    Test that evaluates seated transfers, standing, walking and changes of direction.

  3. Quadriceps isometric muscular strength [ Time Frame: at day 1 ]
    The maximum muscle strength of the quadriceps (dominant limb) will be measured on a bench according to the instructions

  4. Quadriceps isometric muscular strength [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    The maximum muscle strength of the quadriceps (dominant limb) will be measured on a bench according to the instructions

  5. Gait speed test [ Time Frame: at day 1 ]
    Test that evaluate walking speed over 4 meters

  6. Gait speed test [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    Test that evaluate walking speed over 4 meters

  7. Results of the incremental tests [ Time Frame: at day 1 ]
    Peak VO2

  8. Results of the incremental tests [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    Peak VO2

  9. Body composition measurements [ Time Frame: at day 1 ]
    fat body mass

  10. Body composition measurements [ Time Frame: at day 1 ]
    lean body mass

  11. Body composition measurements [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    fat body mass

  12. Body composition measurements [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    lean body mass

  13. Muscle Biopsie [ Time Frame: at day 1 ]
    mitochondrial and histo-biochemical functionality from muscle biopsies

  14. Muscle Biopsie [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    mitochondrial and histo-biochemical functionality from muscle biopsies

  15. Metabolomic analysis [ Time Frame: at day 1 ]
    identification of specific blood and muscle biomarkers in response to retraining

  16. Metabolomic analysis [ Time Frame: at the end of the rehabilitation program (at the end of the 5 weeks) ]
    identification of specific blood and muscle biomarkers in response to retraining



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with systolic chronic heart failure
  • Patients aged 18 to 75 years
  • Referred for participation in the 5-week rehabilitation program
  • At a time distance from an acute coronary syndrome or myocarditis (less than 3 months old) and clinically stabilized.
  • Beneficiary or affiliated with social security coverage

Exclusion Criteria:

  • All the usual criteria considered contra-indicated for cardiac exercise rehabilitation according to the consensus recommendations ( REF)
  • Non-stabilized acute coronary syndrome
  • Decompensated heart insufficiency
  • Stage IV NYHA
  • Severe, uncontrolled disturbances in ventricular rhythm
  • Presence of an intracardiac thrombus with high risk of embolism
  • Presence of pericardial effusion of medium to high importance
  • Recent history of thrombophlebitis with or without pulmonary embolism
  • Obstacle to severe and / or symptomatic left ventricular ejection
  • Any progressive inflammatory and / or infectious condition
  • Severe and symptomatic pulmonary arterial hypertension
  • Inability to perform physical activity
  • Reversible heart disease
  • Patients undergoing circulatory assistance
  • Patients taking blood thinner medication (except Kardegic-type aggregates and direct oral anticoagulants)
  • Patients with known allergy to Xylocaine
  • Pregnant or lactating women
  • Women of childbearing age without contraception
  • Patient under tutorship, curatorship or deprived of liberty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716778


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Ruddy RICHARD         
Sub-Investigator: Guillaume PLAQUEVENT-HOSTACHE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Clinique Médicale Cardio-Pneumologique de Durtol
Investigators
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Principal Investigator: Ruddy RICHARD University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03716778    
Other Study ID Numbers: CHU-411
2017-A00969-44 ( Other Identifier: 2017-A00969-44 )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Heart failure
eccentric
exercise
rehabilitation program
exercise testing
6 min. walk test
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases