NCT05696990

Brief 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). The investigators hypothesize that resistance training exercise with induced a high stress metabolic is more important exercise with induced than a lower stress metabolic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

January 11, 2023

Last Update Submit

February 13, 2024

Conditions

Heart FailureCoronary Artery Disease

Keywords

cardiac rehabilitationresistance trainingstrength trainingexercise for older adults

Outcome Measures

Primary Outcomes (2)

  • Change in Peak VO2 after 3 months

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

    Baseline and 3 months

  • Change in strength knee extensor after 3 months

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

    Baseline and 3 months

Secondary Outcomes (20)

  • Change in VE/VCO2 slope after 3 months

    Baseline and 3 months

  • Change in submaximal exercise capacity after 3 months

    Baseline and 3 months

  • Change in workload maximal after 3 months

    Baseline and 3 months

  • Change in Body fat after 3 months

    Baseline and 3 months

  • Change in lean mass after 3 months

    Baseline and 3 months

  • +15 more secondary outcomes

Study Arms (2)

3/7 RT method

EXPERIMENTAL

perform interval- type endurance exercise at high intensity and resistance training with the 3/7 method

Other: 3/7 Resistance Training Method

3X9 RT method

ACTIVE COMPARATOR

perform interval- type endurance exercise at high intensity and resistance training with the 3X9 method

Other: 3X9 Resistance Training Method

Interventions

3/7 Resistance Training MethodOTHER

3/7 Resistance Training Method

3/7 RT method
3X9 Resistance Training MethodOTHER

3X9 Resistance Training Method

3X9 RT method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 30756168BACKGROUND

  • 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.

    PMID: 33044332BACKGROUND

MeSH Terms

Conditions

Heart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Alexis Gillet

    Université Libre de Bruxelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 25, 2023

Study Start

January 1, 2019

Primary Completion

March 1, 2023

Study Completion

August 30, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

BE(1)