Rehabilitation by Eccentric Exercise in Heart Failure Patients

NCT03716778 | Terminated

• 2 other identifiers: CHU-4112017-A00969-44
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Heart Failure Patient; Rehabilitation Program

Keywords

Heart failure; eccentric; exercise; rehabilitation program; exercise testing; 6 min. walk test

Outcome Measures

Primary Outcomes (2)

• 6 min. walk test (6-WT)

  6 min. walk test (6-WT)

  at day 1

• 6 min. walk test (6-WT)

  6 min. walk test (6-WT)

  at the end of the rehabilitation program (at the end of the 5 weeks)

Secondary Outcomes (16)

• Time up and go test (TUGT)

  at day 1

• Time up and go test (TUGT)

  at the end of the rehabilitation program (at the end of the 5 weeks)

• Quadriceps isometric muscular strength

  at day 1

• Quadriceps isometric muscular strength

  at the end of the rehabilitation program (at the end of the 5 weeks)

• Gait speed test

  at day 1

Study Arms (2)

Classical exercise training modality in concentric mode (CON)

OTHER

Description: Control group, usual medical care according to the rehabilitation recommendations

Other: Eccentric rehabilitation sessions

experimental, active group (ECC)

EXPERIMENTAL

Patients perform a mixed program combining eccentric pedalling session with the usual sessions

Other: Eccentric rehabilitation sessions

Interventions

Eccentric rehabilitation sessions OTHER

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.

Classical exercise training modality in concentric mode (CON); experimental, active group (ECC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Clinique Médicale Cardio-Pneumologique de Durtol: collaborator

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• Plaquevent-Hostache G, Touron J, Costes F, Perrault H, Clerfond G, Cuenin C, Moisa A, Pereira B, Boiteux MC, Eschalier R, Richard R. Effectiveness of combined eccentric and concentric exercise over traditional cardiac exercise rehabilitation programme in patients with chronic heart failure: protocol for a randomised controlled study. BMJ Open. 2019 Sep 26;9(9):e028749. doi: 10.1136/bmjopen-2018-028749.

  PMID: 31558450 DERIVED

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Ruddy RICHARD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 23, 2018
• Study Start: November 9, 2018
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

FR (1)