Clinical trial NCT02387411: High-intensity Interval Versus Combined Exercise Training in CHF
Official title: High-intensity Interval Versus Combined High-intensity Interval and Strength Exercise Training in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
aerobic exercise
strength training
cardiopulmonary rehabilitation
high-intensity exercise training
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic heart failure (CHF) is a clinical syndrome presented with central, cardiac deterioration as well as peripheral vascular and muscular abnormalities, resulting finally to reduced exercise tolerance, quality of life and mortality rates. Exercise training is a major component of rehabilitation / secondary prevention interventions, inducing significant beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity and quality of life, while a positive impact on hospitalization and mortality reduction should not be also excluded. There has been growing interest in the characteristics and modalities of exercise training able to induce optimal benefits. High intensity and interval mode have been shown to induce greater benefits than moderate intensity and continuous mode regimes. Additionally, there has been sound rationale for the inclusion of strength training, which has been also shown able to yield benefits in terms of exercise capacity and quality of life. However, there haven't been much data on the so called combined regimes, which include both aerobic exercise and strength training. This study aims at investigating the effects of combined high-intensity interval and strength training compared to high-intensity interval exercise alone in CHF.


Eligibility criteria: Inclusion Criteria:

* stable heart failure
* ejection fraction \<=45%
* optimal medical treatment
* NYHA class \<=III

Exclusion Criteria:

* contraindications for maximal cardiopulmonary exercise testing (CPET)
* moderate to severe COPD
* inability to follow exercise programs due to orthopaedic problems

Primary outcomes:
measure: aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
timeFrame: 3 months
Secondary outcomes:
measure: strength exercise capacity (assessed by 1-repetition maximum test)
timeFrame: 3 months
measure: quality of life (assessed by MLWHF questionnaire)
timeFrame: 3 months
measure: quadriceps local adaptations (assessed by muscle biopsies)
timeFrame: 3 months
measure: quadriceps cross sectional area (assessed by CT)
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens
Study officials:
affiliation: Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece
name: Serafim Nanas, MD, Prof.
role: STUDY_CHAIR
References:
citation: Tryfonos A, Tzanis G, Pitsolis T, Karatzanos E, Koutsilieris M, Nanas S, Philippou A. Exercise Training Enhances Angiogenesis-Related Gene Responses in Skeletal Muscle of Patients with Chronic Heart Failure. Cells. 2021 Jul 28;10(8):1915. doi: 10.3390/cells10081915.