- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387411
High-intensity Interval Versus Combined Exercise Training in CHF
March 12, 2015 updated by: Serafim Nanas, University of Athens
High-intensity Interval Versus Combined High-intensity Interval and Strength Exercise Training in Chronic Heart Failure
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Athens, Greece, 10675
- Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interval group
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
strength exercise capacity (assessed by 1-repetition maximum test)
Time Frame: 3 months
|
3 months
|
|
quality of life (assessed by MLWHF questionnaire)
Time Frame: 3 months
|
3 months
|
|
quadriceps local adaptations (assessed by muscle biopsies)
Time Frame: 3 months
|
3 months
|
|
quadriceps cross sectional area (assessed by CT)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Serafim Nanas, MD, Prof., Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
February 19, 2015
First Submitted That Met QC Criteria
March 12, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Estimate)
March 13, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- not applied
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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