Interval Training in Heart Failure

NCT03955029 | Unknown

• 1 other identifier: RECHMPL18_0229
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Because of the repeated hospitalizations of this disease, it is considered a costly pathology and with a high mortality rate (23.000 deaths per year in France). Moreover, HF is a severe pathology that affects the quality of life of patients and their families. Treatment and medical follow-up are required. A cardiac rehabilitation program is also a primary indication according to the latest recommendations and repositories in Cardiology. Various studies show that "Interval Training" exercise program improves VO2 peak compared to a "continuous" program, which constitutes a major prognostic factor in the population of heart failure. However, it is sometimes a difficult program to offer to more deconditioned patients as it requires reaching powers around 80% - 95% of its maximum exertion capacity. So, a variant of the interval training is offered, called Progressive Interval Training (PIT), based on the same model as the conventional interval training (CIT), but with an increasing power and breathing threshold, so that the patient can adapt gradually. The hypothesis is that PIT could improve VO2 peak better than CIT in cardiac rehabilitation program. Therefore, study the benefits of PIT training to improve the conditioning and quality of life of patients with chronic heart failure will be studied.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• VO² peak in patients with cardiac heart failure

  Evaluate the effectiveness of endurance rehabilitation program with climbing of ladders (PIT) versus an endurance rehabilitation program with conventional interval training on improving VO² peak in patients with CHF

  Baseline

• VO² peak in patients with cardiac heart failure

  Evaluate the effectiveness of endurance rehabilitation program with climbing of ladders (PIT) versus an endurance rehabilitation program with conventional interval training on improving VO² peak in patients with CHF

  12 weeks

Secondary Outcomes (2)

• Questionnary Short Form Health Survey

  Baseline

• Questionnary Short Form Health Survey

  12 weeks

Study Arms (2)

Conventional Interval training

EXPERIMENTAL

It is a split-type workout that alternates periods of intensity between 60% -95% of the maximum effort (depending on the modality) and periods of passive or active rest between 20-30% of the maximum effort. The experimental group will follow conventional Interval Training

Other: Conventional Interval training

Progressive Interval training

EXPERIMENTAL

It is a split-type workout that alternates periods of intensity between 60% -95% of the maximum effort (depending on the modality) and periods of passive or active rest between 20-30% of the maximum effort. The experimental group will follow progressive Interval Training

Other: Progressive Interval training

Interventions

Progressive Interval training OTHER

heating up 7 minutes at 15 watt, then alternating 30% of the maximum power reached by the patient at Vo2 max for 3 minutes and first peak at 40% of max power, second at 45%, third at 50%, fourth at 55 % and fifth to 60%, then return to calm 3 minutes at 15 watt. Total duration of the endurance session: 30 minutes. The powers of the peak will be modeled according to the Borg (if \<6, increase by 5 watt the value of each peak at the next session).

Progressive Interval training

Conventional Interval training OTHER

warm up 7 minutes at 15 watt, then alternating between plateau at 30% of the max power reached by the patient at VO2 max for 3 minutes and peak at 60% for 1 minute, return to calm 3 minutes at 15 watts. Total duration of the endurance session: 30 minutes. The power of the peak will be modeled according to the Borg (if \<6, increase by 5 watt the value of each peak at the next session)

Conventional Interval training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic systolic heart failure (LVEF \<40%)
• men or women
• years patients or older
• Patients admitted on cardiac rehabilitative medical prescription
• Patients with a functional capacity of 6 Mets or less
• Patients having given their free and informed consent to the study.

You may not qualify if:

• Contraindication to rehabilitation,
• Refusal of the patient to participation in the study
• impaired comprehension
• inability to perform the cyclometer
• participation in another therapeutic protocol simultaneously

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: May 17, 2019
• Study Start: January 10, 2020
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

FR (1)