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Heart FailureNCT05696990

3/7 Resistance Training Method in Cardiac Rehabilitation

A study testing 3/7 Resistance Training Method and 3X9 Resistance Training Method in people with Heart Failure and Coronary Artery Disease, run by Université Libre de Bruxelles at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim of the clinical monocentric study is to assess the resistance training exercise intervention in patients with Heart Failure with reduced Ejection Fraction (HFrEF) and coronary artery disease that will best improve peak oxygen uptake (Peak Vo2) and leg strength (assessed Isokinetic). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Coronary Artery Disease
What is being tested?
3/7 Resistance Training Method and 3X9 Resistance Training Method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteBelgium
Study dates
1 Jan 2019to 30 Aug 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical Coronary artery diseases
  • Heart failure with reduced ejection fraction

Who cannot join

  • angina
  • acutely decompensated heart failure
  • electrocardiographic evidence of ischemia
  • significant valvular disease
  • orthopedic/neurologic disorders that limited exercise

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Erasme Hospital

    Brussels, 1070

Other trials in Belgium

About this study

Official title: 3/7 Resistance Training Method in Cardiac Rehabilitation of Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction

Aim of the clinical monocentric study is to assess the resistance training exercise intervention in patients with Heart Failure with reduced Ejection Fraction (HFrEF) and coronary artery disease that will best improve peak oxygen uptake (Peak Vo2) and leg strength (assessed Isokinetic). The investigators hypothesize that resistance training exercise with induced a high stress metabolic is more important exercise with induced than a lower stress metabolic.

Being tested
3/7 Resistance Training Method, 3X9 Resistance Training Method
Keywords
cardiac rehabilitation, resistance training, strength training, exercise for older adults
Medical subject headings
Heart Failure, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3/7 Resistance Training MethodOther

    3/7 Resistance Training Method

  • 3X9 Resistance Training MethodOther

    3X9 Resistance Training Method

Study groups in NCT05696990
Study groupRoleWhat they receive
3/7 RT methodExperimentalperform interval- type endurance exercise at high intensity and resistance training with the 3/7 method
Receives: Other: 3/7 Resistance Training Method
3X9 RT methodActive comparatorperform interval- type endurance exercise at high intensity and resistance training with the 3X9 method
Receives: Other: 3X9 Resistance Training Method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Peak VO2 after 3 months

    Change in Peak oxygen consumption (VO2) after three 3 months intervention

    Measured: Baseline and 3 months

  2. Change in strength knee extensor after 3 months

    Change in strength knee extensor (60°/sec) after three months intervention

    Measured: Baseline and 3 months

Secondary outcomes (20)

  1. Change in VE/VCO2 slope after 3 months

    Change in ventilatory efficiency (VE/VCO2) slope at baseline and 3 months intervention

    Measured: Baseline and 3 months

  2. Change in submaximal exercise capacity after 3 months

    Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)

    Measured: Baseline and 3 months

  3. Change in workload maximal after 3 months

    Change in workload max at baseline and 3 months intervention

    Measured: Baseline and 3 months

  4. Change in Body fat after 3 months

    Change in Body fat at baseline and 3 months intervention

    Measured: Baseline and 3 months

  5. Change in lean mass after 3 months

    Change in lean mass at baseline and 3 months intervention

    Measured: Baseline and 3 months

  6. Change in leg lean mass after 3 months

    Change in leg lean mass at baseline and 3 months intervention

    Measured: Baseline and 3 months

  7. Change in bone mass after 3 months

    Change in bone mass at baseline and 3 months intervention

    Measured: Baseline and 3 months

  8. Change in Visceral adipose tissue after 3 months

    Change in Visceral adipose tissue measure by Dual-energy X- ray absorptiometry (DEXA) at baseline and 3 months intervention

    Measured: Baseline and 3 months

  9. Change in hand grip force after 3 months

    Change in hand grip force on non dominant hand at baseline and 3 months intervention

    Measured: Baseline and 3 months

  10. Change in ventilation metaboreflex function after 3 months

    Change in ventilation during metaboreflex test at baseline and 3 months intervention (Briefly, the subject is asked to exercise with the non-dominant arm by performing two 5 min handgrip manoeu- vres reaching approximately 50% of pre-determined maximal con- traction, in random order, separated by a 30 min interval: one bout with circulatory occlusion during the last 10 s of exercise and the all 3 min recovery phase ('clamp session'). During the clamp session, forearm cuff inflation to 30 mmHg above systolic blood pressure from the last 10 s of exercise till the end of the 3 min recovery phase; after cuff inflation, the subject is instructed to relax. Ergore- ceptor sensitivity is quantified as the percentage of the ventilatory and haemodynamic response to exercise maintained by circulatory occlusion during the third minute compared with the third minute of basal recovery.)

    Measured: Baseline and 3 months

  11. Change in diastolic blood pressure metaboreflex function after 3 months

    Change in diastolic blood pressure during metaboreflex test at baseline and 3 months intervention

    Measured: Baseline and 3 months

  12. Change in heart rate at rest after 3 months

    Change in heart rate at baseline and 3 months intervention

    Measured: Baseline and 3 months

  13. Change in resting heart rate variability at rest after 3 months

    Change in resting heart rate variability at baseline and 3 months intervention

    Measured: Baseline and 3 months

  14. Change 30 s sit-to-stand after 3 months

    Change 30 s sit-to-stand at baseline and 3 months intervention

    Measured: Baseline and 3 months

  15. Change in isometric strength knee extensor after 3 months

    Change in strength knee extensor (isometric) at baseline and 3 months intervention

    Measured: Baseline and 3 months

  16. Change in 120°/sec strength knee extensor after 3 months

    Change in strength knee extensor (120°/sec) at baseline and 3 months intervention

    Measured: Baseline and 3 months

  17. Change in 180°/sec strength knee extensor after 3 months

    Change in strength knee extensor (180°/sec) at baseline and 3 months intervention

    Measured: Baseline and 3 months

  18. Change strength knee extensor in leg extension after 3 months

    Change in one repetition maximal in leg extensor machine at baseline and 3 months intervention

    Measured: Baseline and 3 months

  19. Change in sub maximal strength knee extensor in leg extension after 3 months

    Change in 10 repetitions maximal in leg extensor machine at baseline and 3 months intervention

    Measured: Baseline and 3 months

  20. Change in heart rate recovery after 3 months

    Change in heart rate recovery at baseline and 3 months intervention

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start1 Jan 2019
  3. Primary completion1 Mar 2023
  4. Study completion30 Aug 2023

Resources

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
Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696990
Sponsor's protocol ID
P2020/489
Status last verified
Feb 2024
First submitted
11 Jan 2023
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stragier S, Baudry S, Carpentier A, Duchateau J. Efficacy of a new strength training design: the 3/7 method. Eur J Appl Physiol. 2019 May;119(5):1093-1104. doi: 10.1007/s00421-019-04099-5. Epub 2019 Feb 12.

    PubMed 30756168

  • Duchateau J, Stragier S, Baudry S, Carpentier A. Strength Training: In Search of Optimal Strategies to Maximize Neuromuscular Performance. Exerc Sport Sci Rev. 2021 Jan;49(1):2-14. doi: 10.1249/JES.0000000000000234.

    PubMed 33044332

Questions about this trial

What is this clinical trial studying?

A study testing 3/7 Resistance Training Method and 3X9 Resistance Training Method in people with Heart Failure and Coronary Artery Disease, run by Université Libre de Bruxelles at 1 site in Belgium.

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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 Feb 2024. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Peak VO2 after 3 months (time frame: Baseline and 3 months). 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 NCT05696990, which also lists 2 linked publications.

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 15 Feb 2024.

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