3/7 Resistance Training Method in Cardiac Rehabilitation

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696990
• Other study ID #: P2020/489
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2024
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 30, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical Coronary artery diseases

• Heart failure with reduced ejection fraction

Exclusion Criteria:

• angina

• acutely decompensated heart failure

• electrocardiographic evidence of ischemia

• significant valvular disease

• orthopedic/neurologic disorders that limited exercise

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Intervention

Other:
• 3/7 Resistance Training Method
3/7 Resistance Training Method
• 3X9 Resistance Training Method
3X9 Resistance Training Method

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak VO2 after 3 months	Change in Peak oxygen consumption (VO2) after three 3 months intervention	Baseline and 3 months
Primary	Change in strength knee extensor after 3 months	Change in strength knee extensor (60°/sec) after three months intervention	Baseline and 3 months
Secondary	Change in VE/VCO2 slope after 3 months	Change in ventilatory efficiency (VE/VCO2) slope at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in submaximal exercise capacity after 3 months	Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)	Baseline and 3 months
Secondary	Change in workload maximal after 3 months	Change in workload max at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in Body fat after 3 months	Change in Body fat at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in lean mass after 3 months	Change in lean mass at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in leg lean mass after 3 months	Change in leg lean mass at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in bone mass after 3 months	Change in bone mass at baseline and 3 months intervention	Baseline and 3 months
Secondary	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	Baseline and 3 months
Secondary	Change in hand grip force after 3 months	Change in hand grip force on non dominant hand at baseline and 3 months intervention	Baseline and 3 months
Secondary	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.)	Baseline and 3 months
Secondary	Change in diastolic blood pressure metaboreflex function after 3 months	Change in diastolic blood pressure during metaboreflex test at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in heart rate at rest after 3 months	Change in heart rate at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in resting heart rate variability at rest after 3 months	Change in resting heart rate variability at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change 30 s sit-to-stand after 3 months	Change 30 s sit-to-stand at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in isometric strength knee extensor after 3 months	Change in strength knee extensor (isometric) at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in 120°/sec strength knee extensor after 3 months	Change in strength knee extensor (120°/sec) at baseline and 3 months intervention	Baseline and 3 months
Secondary	Change in 180°/sec strength knee extensor after 3 months	Change in strength knee extensor (180°/sec) at baseline and 3 months intervention	Baseline and 3 months
Secondary	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	Baseline and 3 months
Secondary	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	Baseline and 3 months
Secondary	Change in heart rate recovery after 3 months	Change in heart rate recovery at baseline and 3 months intervention	Baseline and 3 months