High-intensity Interval Versus Combined Exercise Training in CHF
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
High-intensity interval exercise training
Combined exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, aerobic exercise, strength training, cardiopulmonary rehabilitation, high-intensity exercise training
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
Sites / Locations
- Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Interval group
Combined group
Arm Description
high-intensity interval exercise training
combined exercise training
Outcomes
Primary Outcome Measures
aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
Secondary Outcome Measures
strength exercise capacity (assessed by 1-repetition maximum test)
quality of life (assessed by MLWHF questionnaire)
quadriceps local adaptations (assessed by muscle biopsies)
quadriceps cross sectional area (assessed by CT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387411
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, aerobic exercise, strength training, cardiopulmonary rehabilitation, high-intensity exercise training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interval group
Arm Type
Active Comparator
Arm Description
high-intensity interval exercise training
Arm Title
Combined group
Arm Type
Active Comparator
Arm Description
combined exercise training
Intervention Type
Other
Intervention Name(s)
High-intensity interval exercise training
Intervention Description
High-intensity interval exercise training [4 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)]
Intervention Type
Other
Intervention Name(s)
Combined exercise training
Intervention Description
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 Measure Information:
Title
aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
strength exercise capacity (assessed by 1-repetition maximum test)
Time Frame
3 months
Title
quality of life (assessed by MLWHF questionnaire)
Time Frame
3 months
Title
quadriceps local adaptations (assessed by muscle biopsies)
Time Frame
3 months
Title
quadriceps cross sectional area (assessed by CT)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serafim Nanas, MD, Prof.
Organizational Affiliation
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens
City
Athens
ZIP/Postal Code
10675
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
34440684
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.
Results Reference
derived
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High-intensity Interval Versus Combined Exercise Training in CHF
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