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Acute Coronary SyndromeCITIUSNCT04102410

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

A study testing Sprints, Vertical jumps and Questionary Short Form-12 (SF-12) in people with Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Sprints, Vertical jumps and Questionary Short Form-12 (SF-12)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteFrance
Study dates
30 Sep 2019to 4 Apr 2022
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chu Saint-Etienne

    Saint-Etienne

Other trials in France

About this study

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.

Read the detailed description

In this sudy, each patient has a force and a velocity that can be optimized with training to achieve maximum power. This optimization can be evaluated through a force-velocity profile, measured from an only sprint on a cycloergometer.

The hypothesis that force-velocity profile could be used in cardiac rehabilitation in coronary patients to induce a force-velocity balance adapted through personalized sessions and regular medical follow-up.

This prospective, controlled, randomized and open label study will attempt to evaluate further the relevance of force or velocity training based on the initial force-velocity profile of coronary patients included in the cardiac rehabilitation program in the University Hospital of Saint-Etienne.

Being tested
Sprints, Vertical jumps, Questionary Short Form-12 (SF-12), activity actigraph, Program composed of two 2 training strategies
Keywords
Cardiac rehabilitation, Physical activity, Force-velocity profile, Autonomic nervous system, Coronary artery disease
Medical subject headings
Acute Coronary Syndrome, Motor Activity, Coronary Artery Disease

What participants receive

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

  • SprintsOther

    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.

  • Vertical jumpsOther

    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.

  • 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.

  • activity actigraphDevice

    Also called Wristlet connected

    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.

  • Program composed of two 2 training strategiesOther

    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.

  • Program of usual practiceOther

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

Study groups in NCT04102410
Study groupRoleWhat they receive
Experimental groupExperimentalPatient 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.
Receives: Other: Sprints; Other: Vertical jumps; Other: Questionary Short Form-12 (SF-12); Device: activity actigraph; Other: Program composed of two 2 training strategies
Control groupSham comparatorPatient 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.
Receives: Other: Sprints; Other: Vertical jumps; Other: Questionary Short Form-12 (SF-12); Device: activity actigraph; Other: Program of usual practice

What is being measured

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

  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).

    Measured: Months: 0 and 2

Secondary outcomes (12)

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

    Comparison VO2 max (volume of oxygen maximum in ml/min/kg) during a Cardio-Pulmonary Exercise Test (CPET).

    Measured: Months: 0 and 2

  2. Power at first ventilatory threshold (SV1)

    Comparison value of power at first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).

    Measured: Months: 0 and 2

  3. Maximum aerobic power (in watt)

    Comparison maximum aerobic power (in watt) during a Cardio-Pulmonary Exercise Test (CPET).

    Measured: Months: 0 and 2

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

    Comparison voluntary muscle power (in kg) during a static muscle testing on quadriceps.

    Measured: Months: 0 and 2

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

    Comparison voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps.

    Measured: Months: 0 and 2

  6. Value of muscular endurance (in min) during a static muscle testing on quadriceps

    Comparison value of muscular endurance (in min) during a static muscle testing on quadriceps.

    Measured: Months: 0 and 2

  7. Value of muscular endurance (in min) during a dynamic muscle testing on quadriceps

    Comparison value of muscular endurance (in min) during a dynamic muscle testing on quadriceps.

    Measured: Months: 0 and 2

  8. Standard Deviation of the Normal R-R interval (SDNN) index

    Measured by holter electrocardiogram during 24 hours.

    Measured: Months: 0 and 2

  9. BaroReflex Sensitivity (BRS) (in ms/mmHg)

    Measured by baroreflex.

    Measured: Months: 0 and 2

  10. Physical activity (in Metabolic Equivalent of Task (MET)-min/week)

    Assessment of Physical activity (in Metabolic Equivalent of Task (MET)-min/week).

    Measured by activity actigraph.

    Measured: Month: 0

  11. Sedentary life (in hour/day)

    Assessment of Sedentary life (in hour/day). Measured by activity actigraph.

    Measured: Month: 0

  12. SF-12 questionnaire score

    The SF-12 is a self-questionnaire to assess the quality of life. This tool is an abbreviated version of the "Medical Outcomes Study Short-Form General Health Survey" (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life).

    Measured: Months: 0 and 2

Timeline

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

  1. First posted25 Sep 2019
  2. Study start30 Sep 2019
  3. Primary completion4 Apr 2022
  4. Study completion4 Apr 2022

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102410
Sponsor's protocol ID
1708238
Other IDs
2018-A01613-52
Acronym
CITIUS
Status last verified
Jun 2022
First submitted
23 Sep 2019
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sprints, Vertical jumps and Questionary Short Form-12 (SF-12) in people with Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

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 5 inclusion and 4 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 3 Jun 2022. 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 France. 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. Some participants in this study may receive a placebo. 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?

volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1) (time frame: Months: 0 and 2). 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 NCT04102410.

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 3 Jun 2022; AzTrials last refreshed its copy on 4 Nov 2026.

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