High-intensity Interval Versus Combined Exercise Training in CHF

Heart Failure Clinical Trial

Official title:

High-intensity Interval Versus Combined High-intensity Interval and Strength Exercise Training in Chronic Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02387411
• Other study ID #: not applied
• Status: Active, not recruiting
• Phase: N/A
• First received: February 19, 2015
• Last updated: March 12, 2015
• Start date: May 2010
• Est. completion date: June 2015

Study information

• Verified date: March 2015
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• High-intensity interval exercise training
High-intensity interval exercise training [4 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)]
• Combined exercise training
High intensity [2 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)] and strength exercise training (2-4 sets, 10-12 reps, 60-65% 1RM, for quadriceps and hamstrings, 14 min in total)

Locations

Country	Name	City	State
Greece	Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aerobic exercise capacity (assessed by cardiopulmonary exercise testing)		3 months	No
Secondary	strength exercise capacity (assessed by 1-repetition maximum test)		3 months	No
Secondary	quality of life (assessed by MLWHF questionnaire)		3 months	No
Secondary	quadriceps local adaptations (assessed by muscle biopsies)		3 months	No
Secondary	quadriceps cross sectional area (assessed by CT)		3 months	No