Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients

NCT04102410 | Completed

• 2 other identifiers: 17082382018-A01613-52
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac rehabilitation includes aerobic and anaerobic training adapted to cardiovascular pathology for which cardiac rehabilitation is prescribed. It is essential to adapt the content of these cardiac rehabilitation sessions to optimize aerobic and anaerobic performance and quality of life. Improvement of the first ventilatory threshold is one of the main objectives since it illustrates the adaptation of the patient to submaximal exercise, typical of everyday life. The research laboratory "Autonomous Nervous System - Epidemiology, Physiology, Engineering, Health" (SPA-EPIS) has an international expertise in training optimization in top-athletes. He have shown the importance of the relationship between the power-force-velocity profile and athletes performances.

Conditions

Acute Coronary Syndrome

Keywords

Cardiac rehabilitation; Physical activity; Force-velocity profile; Autonomic nervous system; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)

  Change in VO2 (volume of oxygen in ml/min/kg) at the first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).

  Months: 0 and 2

Secondary Outcomes (12)

• VO2 max (volume of oxygen maximum in ml/min/kg)

  Months: 0 and 2

• Power at first ventilatory threshold (SV1)

  Months: 0 and 2

• Maximum aerobic power (in watt)

  Months: 0 and 2

• Voluntary muscle power (in kg) during a static muscle testing on quadriceps

  Months: 0 and 2

• Voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps

  Months: 0 and 2

Study Arms (2)

Experimental group

EXPERIMENTAL

Patient with acute coronary syndrome will be included. They will have sprints, vertical jumps, questionary Short Form-12 (SF-12), activity actigraph and program composed of two 2 training strategies.

Other: Sprints; Other: Vertical jumps; Other: Questionary Short Form-12 (SF-12); Device: activity actigraph; Other: Program composed of two 2 training strategies

Control group

SHAM COMPARATOR

Patient with acute coronary syndrome will be included. They will have sprints, vertical jumps, questionary Short Form-12 (SF-12), activity actigraph and program of usual practice.

Other: Sprints; Other: Vertical jumps; Other: Questionary Short Form-12 (SF-12); Device: activity actigraph; Other: Program of usual practice

Interventions

Sprints OTHER

Two sprints of 8 seconds on a cycle ergometer will be performed for determine Force/Velocity Profile (FVP). Realized at inclusion and 2 months after.

Control group; Experimental group

Vertical jumps OTHER

Two vertical jumps will be performed. Height of theses vertical jumps will be measured by application "My jump 2" to determine muscle power. Realized at inclusion and 2 months after.

Control group; Experimental group

Questionary Short Form-12 (SF-12) OTHER

Questionary Short Form-12 (SF-12) will be performed to evaluate quality of life. It is composed of 12 questions. Realized at inclusion and 2 months after.

Control group; Experimental group

activity actigraph DEVICE

Activity actigraph will be wearing by patient during 7 consecutive days. It measures the level of physical activity and the sedentary lifestyle of patients. Realized at inclusion and 2 months after.

Also known as: Wristlet connected

Control group; Experimental group

Program composed of two 2 training strategies OTHER

Program composed of two 2 training strategies according to the initial Force/Velocity Profile (FVP) will be realized at the inclusion. There are : * Strategy "experimental-speed": speed training strategy for subjects with a force-speed profile (PFV) in favour of force * Strategy "experimental-force": force training strategy for subjects with a force-speed profile (PFV) in favour of speed.

Experimental group

Program of usual practice OTHER

Program composed of training in force and speed independently of the initial Force/Velocity Profile (FVP).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute coronary syndrome treated within the last 6 months
• Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
• During initial effort test: Maximum aerobic power≥ 60 watts for women and ≥ 80 watts for men
• Patient affiliated or beneficiary to social security
• Signed informed consent

You may not qualify if:

• Significant co-morbidities limited practice of physical activity
• Inability to submit to medical monitoring of the program
• Patient deprived of liberty or patient under guardianship
• Pregnant woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Jean Monnet University: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Motor Activity; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• David HUPIN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: September 30, 2019
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)