Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06107452
Other study ID # 23CH152
Secondary ID 2023-A01452-43
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2024
Est. completion date February 2025

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact David HUPIN, MD
Phone (0)4 77 82 84 13
Email David.Hupin@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery


Description:

Our study aims to evaluate the application of HRV in regulating training load based on fatigue levels in cardiac rehabilitation patients utilizing the PFVP framework.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date February 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 - Acute Coronary Syndrome treated in the last 6 months - Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass) - Initial CPETt: MPA = 60w in women and =80w in men - French - Informed consent Exclusion Criteria: - Significant co-morbidities limited practice of physical activity

Study Design


Related Conditions & MeSH terms


Intervention

Other:
training strategy with adaptation of training strategies to the ANS
a training strategy for subjects whose PFVP is in favour of strength or speed with training load adjusted according to SNA
training strategy (standard practice)
a training strategy for subjects whose PFVP is in favour of strength or speed

Locations

Country Name City State
France Chu Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The root mean square of successive differences in heart rate or RMSSD The root mean square of successive differences in heart rate or RMSSD will be measured from a nocturnal Holter ECG recording at the end of 8 weeks of exercise retraining and compared with the initial pre-training value. weeks of exercise re-training and compared with the initial pre-training value. Baseline to 2 months
Secondary Value of maximum oxygen consumption VO2 max (ml/min/kg) thanks to 24-hour ECG recording Baseline to 2 months
Secondary Assessment of the ANS sympathetic branch Assessment of the ANS sympathetic branch thanks to SDNN index value Baseline to 2 months
Secondary Assessment of the ANS parasympathetic branch Assessment of the ANS parasympathetic branch thanks to RMSSSD index value Baseline to 2 months
Secondary non-invasive measurement of arterial stiffness value of pulse wave propagation velocity Baseline to 2 months
Secondary measurement of upper and lower limb muscle strength it's a composite outcome :
measurement of handgrip (kg) thanks to Jamar hydraulic hand dynamometer
measurement maximum quadriceps strength (kg) thanks to Contrex, Physiomed
Baseline to 2 months
Secondary assessment of PFVP evolution assessment of PFVP evolution thaks to cycloergometer sprint (Monark, Vansbro) Baseline to 2 months
Secondary assessment of physical a activity and sedentary behavior it's a composite outcome :
assessment of physical a activity and sedentary behavior thanks to actimetry (Actigraph GT9x)
assessment of physical a activity and sedentary behavior thanks to Adult Physical Activity Questionnaire (APAQ)
Baseline to 2 months
Secondary quality of life assessment it's a composite outcome :
with mental quality of life score
with physical quality of life score
Baseline to 2 months
Secondary assessment of subjective fatigue assessment of subjective fatigue thanks to FACIT-F questionary Baseline to 2 months
Secondary biological data it's a composite outcome : complete blood biology and relevant inflammatory biomarkers involved in cardiac rehabilitation. Baseline to 2 months
See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT05412927 - AngelMed Guardian® System PMA Post Approval Study
Completed NCT02750579 - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? N/A
Completed NCT04102410 - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients N/A
Enrolling by invitation NCT03342131 - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation NCT04676100 - International CR Registry
Completed NCT03590535 - 5th Generation cTnT in ED ACS
Recruiting NCT05437900 - INSIGHTFUL-FFR Clinical Trial Phase 4
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated NCT04316481 - IDE-ALERTS Continued Access Study N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT04852146 - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT02944123 - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR) Phase 3
Completed NCT04077229 - Piloting Text Messages to Promote Positive Affect and Physical Activity N/A
Active, not recruiting NCT02922140 - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit N/A
Completed NCT02673437 - Rivaroxaban ACS Specialist Cohort Event Monitoring Study