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High-intensity Interval Versus Combined Exercise Training in CHF

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ClinicalTrials.gov Identifier: NCT02387411
Recruitment Status : Unknown
Verified March 2015 by Serafim Nanas, University of Athens.
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Serafim Nanas, University of Athens

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: High-intensity interval exercise training Other: Combined exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-intensity Interval Versus Combined High-intensity Interval and Strength Exercise Training in Chronic Heart Failure
Study Start Date : May 2010
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Interval group
high-intensity interval exercise training
Other: High-intensity interval exercise training
High-intensity interval exercise training [4 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)]

Active Comparator: Combined group
combined exercise training
Other: 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)




Primary Outcome Measures :
  1. aerobic exercise capacity (assessed by cardiopulmonary exercise testing) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. strength exercise capacity (assessed by 1-repetition maximum test) [ Time Frame: 3 months ]
  2. quality of life (assessed by MLWHF questionnaire) [ Time Frame: 3 months ]
  3. quadriceps local adaptations (assessed by muscle biopsies) [ Time Frame: 3 months ]
  4. quadriceps cross sectional area (assessed by CT) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387411


Locations
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Greece
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens
Athens, Greece, 10675
Sponsors and Collaborators
University of Athens
Investigators
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Study Chair: Serafim Nanas, MD, Prof. Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece

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Responsible Party: Serafim Nanas, Prof Critical Care Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT02387411     History of Changes
Other Study ID Numbers: not applied
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015

Keywords provided by Serafim Nanas, University of Athens:
heart failure
aerobic exercise
strength training
cardiopulmonary rehabilitation
high-intensity exercise training

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases