NCT05391620

Brief Summary

The study proposes to measure the effect of resitance training (RT) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population. 3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). This method is compare to 3X9 method, 3 series of 9 repetitions with inter-set (1min).The training exercise consisted of contraction on machine (leg press, triceps press, leg curl, traction, leg extension) with load of \~ 70% of one repetition maximal (1RM). Before these trainings all subject perform HIIT on bicycles (2 min high intensity (80% Wmax) and 2 min low intensity (50% Wmax) during 30 minutes. The investigators collect blood sample before exercice, after HIIT and after RT. It is randomized cross-over study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2022

Shorter than P25 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

February 22, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2022

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

April 7, 2022

Last Update Submit

February 13, 2024

Conditions

Keywords

Cardiac rehabilitionexercise therapymetabolic stress

Outcome Measures

Primary Outcomes (6)

  • Change in Lactate

    mmol/l

    within 2 minutes after TR training session on day 1

  • change in Testosterone

    nmol/l

    within 2 minutes after TR training session on day 1

  • change Glucocorticoid Cortisol

    nmol/l

    within 2 minutes after TR training session on day 1

  • change in Growth Hormone

    ng/ml

    within 2 minutes after TR training session on day 1

  • change in ph

    venoust

    within 2 minutes after TR training session on day 1

  • change PCO2 venoust

    mm Hg

    within 2 minutes after TR training session on day 1

Secondary Outcomes (2)

  • Borg scale

    within 4 minutes after TR training session on day 1

  • Pleasure of the session scale

    within 4 minutes after TR training session on day 1

Study Arms (2)

CAD group

EXPERIMENTAL

Coronary artery diseases

Other: Cardiac rehabilitation with 3/7 methodOther: Cardiac rehabilitation with 3X9 method

HFrEF group

EXPERIMENTAL

Heart Failure with reduced Ejection Fraction

Other: Cardiac rehabilitation with 3/7 methodOther: Cardiac rehabilitation with 3X9 method

Interventions

HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3/7 method 3 rep (15 sec of rest), 4 rep (15 sec), 5 rep (15 sec), 6 rep (15 sec), 7 rep. (total volume : 25 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension. 1 minute between each machine is planned.

Also known as: 3/7 method
CAD groupHFrEF group

HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3X9 method 9 rep 1 minute of rest, 9 rep (1 min) and 9 rep (total volume : 27 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension. 1 minute between each machine is planned

Also known as: 3X9 method
CAD groupHFrEF group

Eligibility Criteria

Age18 Years+
Sexmale
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 (1)

  • Mang ZA, Realzola RA, Ducharme J, Bellissimo GF, Beam JR, Mermier C, de Castro Magalhaes F, Kravitz L, Amorim FT. The effect of repetition tempo on cardiovascular and metabolic stress when time under tension is matched during lower body exercise. Eur J Appl Physiol. 2022 Jun;122(6):1485-1495. doi: 10.1007/s00421-022-04941-3. Epub 2022 Apr 8.

    PMID: 35394146BACKGROUND

MeSH Terms

Conditions

Heart FailureCoronary Artery Disease

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Philippe van de borne, Professor

    Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2022

First Posted

May 26, 2022

Study Start

February 22, 2022

Primary Completion

June 10, 2022

Study Completion

October 25, 2022

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

on request

Locations