Heart FailureNCT02387411
High-intensity Interval Versus Combined Exercise Training in CHF
A study testing High-intensity interval exercise training and Combined exercise training in people with Heart Failure, run by University of Athens at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- High-intensity interval exercise training and Combined exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- May 2010to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable heart failure
- ejection fraction <=45%
- optimal medical treatment
- NYHA class <=III
Who cannot join
- contraindications for maximal cardiopulmonary exercise testing (CPET)
- moderate to severe COPD
- inability to follow exercise programs due to orthopaedic problems
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens
Athens, 10675
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- High-intensity interval exercise training, Combined exercise training
- Keywords
- heart failure, aerobic exercise, strength training, cardiopulmonary rehabilitation, high-intensity exercise training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval exercise trainingOther
High-intensity interval exercise training [4 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)]
Combined exercise trainingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Interval group | Active comparator | high-intensity interval exercise training Receives: Other: High-intensity interval exercise training |
| Combined group | Active comparator | combined exercise training Receives: Other: Combined exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
Measured: 3 months
Secondary outcomes (4)
strength exercise capacity (assessed by 1-repetition maximum test)
Measured: 3 months
quality of life (assessed by MLWHF questionnaire)
Measured: 3 months
quadriceps local adaptations (assessed by muscle biopsies)
Measured: 3 months
quadriceps cross sectional area (assessed by CT)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMay 2010
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafim Nanas, University of Athens
- Investigators
- Serafim Nanas, MD, Prof., Study chair, Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387411
- Sponsor's protocol ID
- not applied
- Status last verified
- Mar 2015
- First submitted
- 19 Feb 2015
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tryfonos A, Tzanis G, Karatzanos Epsilon, Koutsilieris M, Nanas S, Philippou A. Inflammation- and Tissue Remodeling-Related Gene Responses in Skeletal Muscle of Heart Failure Patients Following High-Intensity Interval Training. Rev Cardiovasc Med. 2023 Feb 6;24(2):46. doi: 10.31083/j.rcm2402046. eCollection 2023 Feb.
PubMed 39077398Alshamari M, Kourek C, Sanoudou D, Delis D, Dimopoulos S, Rovina N, Nanas S, Karatzanos E, Philippou A. Does the Addition of Strength Training to a High-Intensity Interval Training Program Benefit More the Patients with Chronic Heart Failure. Rev Cardiovasc Med. 2023 Jan 16;24(1):29. doi: 10.31083/j.rcm2401029. eCollection 2023 Jan.
PubMed 39076879Tryfonos 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.
PubMed 34440684
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Versus Combined High-intensity Interval and Strength Exercise Training in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02387411
- Acronym / sponsor ID
- not applied
- Conditions
- Heart Failure
- Keywords
- heart failure, aerobic exercise, strength training, cardiopulmonary rehabilitation, high-intensity exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval group | Active comparator | Other: High-intensity interval exercise traininghigh-intensity interval exercise training |
| Combined group | Active comparator | Other: Combined exercise trainingcombined exercise training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stable heart failure
- ejection fraction <=45%
- optimal medical treatment
- NYHA class <=III
Key exclusion criteria (3 listed)
- contraindications for maximal cardiopulmonary exercise testing (CPET)
- moderate to severe COPD
- inability to follow exercise programs due to orthopaedic problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval exercise trainingHigh-intensity interval exercise training [4 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)] | Other | Interval group |
| Combined exercise trainingHigh 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) | Other | Combined group |
Primary outcome
aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
Time frame: 3 months
4 secondary outcomes
strength exercise capacity (assessed by 1-repetition maximum test)
Time frame: 3 months
quality of life (assessed by MLWHF questionnaire)
Time frame: 3 months
quadriceps local adaptations (assessed by muscle biopsies)
Time frame: 3 months
quadriceps cross sectional area (assessed by CT)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Derived from this study: PubMed 39077398Tryfonos A, Tzanis G, Karatzanos Epsilon, Koutsilieris M, Nanas S, Philippou A. Inflammation- and Tissue Remodeling-Related Gene Responses in Skeletal Muscle of Heart Failure Patients Following High-Intensity Interval Training. Rev Cardiovasc Med. 2023 Feb 6;24(2):46. doi: 10.31083/j.rcm2402046. eCollection 2023 Feb.
- Derived from this study: PubMed 39076879Alshamari M, Kourek C, Sanoudou D, Delis D, Dimopoulos S, Rovina N, Nanas S, Karatzanos E, Philippou A. Does the Addition of Strength Training to a High-Intensity Interval Training Program Benefit More the Patients with Chronic Heart Failure. Rev Cardiovasc Med. 2023 Jan 16;24(1):29. doi: 10.31083/j.rcm2401029. eCollection 2023 Jan.
- Derived from this study: PubMed 34440684Tryfonos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serafim Nanas, MD, Prof. study chair
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval exercise training and Combined exercise training in people with Heart Failure, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aerobic exercise capacity (assessed by cardiopulmonary exercise testing) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387411, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.