Chronic Heart Failure PatientREX-HFNCT03716778
Rehabilitation by Eccentric Exercise in Heart Failure Patients
A study testing Eccentric rehabilitation sessions in people with Chronic Heart Failure Patient and Rehabilitation Program, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Heart Failure Patient, Rehabilitation Program
- What is being tested?
- Eccentric rehabilitation sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2018to 26 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- Eccentric rehabilitation sessions
- Keywords
- Heart failure, eccentric, exercise, rehabilitation program, exercise testing, 6 min. walk test
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric rehabilitation sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Classical exercise training modality in concentric mode (CON) | Other | Description: Control group, usual medical care according to the rehabilitation recommendations Receives: Other: Eccentric rehabilitation sessions |
| experimental, active group (ECC) | Experimental | Patients perform a mixed program combining eccentric pedalling session with the usual sessions Receives: Other: Eccentric rehabilitation sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min. walk test (6-WT)
6 min. walk test (6-WT)
Measured: at day 1
6 min. walk test (6-WT)
6 min. walk test (6-WT)
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Secondary outcomes (16)
Time up and go test (TUGT)
Test that evaluates seated transfers, standing, walking and changes of direction.
Measured: at day 1
Time up and go test (TUGT)
Test that evaluates seated transfers, standing, walking and changes of direction.
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Quadriceps isometric muscular strength
The maximum muscle strength of the quadriceps (dominant limb) will be measured on a bench according to the instructions
Measured: at day 1
Quadriceps isometric muscular strength
The maximum muscle strength of the quadriceps (dominant limb) will be measured on a bench according to the instructions
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Gait speed test
Test that evaluate walking speed over 4 meters
Measured: at day 1
Gait speed test
Test that evaluate walking speed over 4 meters
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Results of the incremental tests
Peak VO2
Measured: at day 1
Results of the incremental tests
Peak VO2
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Body composition measurements
fat body mass
Measured: at day 1
Body composition measurements
lean body mass
Measured: at day 1
Body composition measurements
fat body mass
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Body composition measurements
lean body mass
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Muscle Biopsie
mitochondrial and histo-biochemical functionality from muscle biopsies
Measured: at day 1
Muscle Biopsie
mitochondrial and histo-biochemical functionality from muscle biopsies
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Metabolomic analysis
identification of specific blood and muscle biomarkers in response to retraining
Measured: at day 1
Metabolomic analysis
identification of specific blood and muscle biomarkers in response to retraining
Measured: at the end of the rehabilitation program (at the end of the 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start9 Nov 2018
- Primary completion26 May 2022
- Study completion26 May 2022
Why it stopped: This premature end of the study is due to the lack of human resources and the fact that the forceps used to perform the biopsies for this study have not been marketed since January 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart Failure PatientStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Of Medical Cardio Pneumologie, Durtol
- Responsible party
- Sponsor
- Investigators
- Ruddy RICHARD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716778
- Sponsor's protocol ID
- CHU-411
- Other IDs
- 2017-A00969-44
- Acronym
- REX-HF
- Status last verified
- Jun 2023
- First submitted
- 8 Oct 2018
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31558450
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03716778
- Acronym / sponsor ID
- REX-HF / CHU-411
- Keywords
- Heart failure, eccentric, exercise, rehabilitation program, exercise testing, 6 min. walk test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This premature end of the study is due to the lack of human resources and the fact that the forceps used to perform the biopsies for this study have not been marketed since January 2023.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Clinical Of Medical Cardio Pneumologie, Durtol
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical exercise training modality in concentric mode (CON) | Other | Other: Eccentric rehabilitation sessionsDescription: Control group, usual medical care according to the rehabilitation recommendations |
| experimental, active group (ECC) | Experimental | Other: Eccentric rehabilitation sessionsPatients perform a mixed program combining eccentric pedalling session with the usual sessions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric rehabilitation sessionsECC 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. | Other | Classical exercise training modality in concentric mode (CON), experimental, active group (ECC) |
Primary outcome
6 min. walk test (6-WT)
Time frame: at day 1
6 min. walk test (6-WT)
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)
16 secondary outcomes
Time up and go test (TUGT)
Time frame: at day 1
Time up and go test (TUGT)
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Quadriceps isometric muscular strength
Time frame: at day 1
Quadriceps isometric muscular strength
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Gait speed test
Time frame: at day 1
Gait speed test
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Results of the incremental tests
Time frame: at day 1
Results of the incremental tests
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Body composition measurements
Time frame: at day 1
Body composition measurements
Time frame: at day 1
Body composition measurements
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Body composition measurements
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Muscle Biopsie
Time frame: at day 1
Muscle Biopsie
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Metabolomic analysis
Time frame: at day 1
Metabolomic analysis
Time frame: at the end of the rehabilitation program (at the end of the 5 weeks)
Results and safety
The study was stopped early (reason given: This premature end of the study is due to the lack of human resources and the fact that the forceps used to perform the biopsies for this study have not been marketed since January 2023.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Derived from this study: PubMed 31558450Plaquevent-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruddy RICHARD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric rehabilitation sessions in people with Chronic Heart Failure Patient and Rehabilitation Program, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This premature end of the study is due to the lack of human resources and the fact that the forceps used to perform the biopsies for this study have not been marketed since January 2023.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 min. walk test (6-WT) (time frame: at day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03716778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.