Chronic Heart FailureNCT01071629
Exercise Training Effects in Patients With Heart Failure
A study testing Exercise training in people with Chronic Heart Failure, run by University of Athens at 1 site in Greece.
Trial summary
Chronic heart failure (CHF) is a common syndrome characterized by several central hemodynamic and peripheral vascular and muscle abnormalities including autonomic imbalance, neuro-hormonal over-activation and decreased oxidative status. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2004to Sep 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 systolic heart failure
- NYHA functional class ≤ III
- Optimal medical treatment
Who cannot join
- Contraindications for a maximal cardiopulmonary exercise testing (CPET) according to the American Thoracic Society/American College of Chest Physicians Statement
- Moderate to severe COPD
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, First Critical Care Unit, School of Medicine, National & Kapodistrian University of Athens
Athens, 10676
About this study
Official title: Aerobic Interval Training Versus Combined Aerobic Interval Training and Strength Training Effects in Patients With Heart Failure
Chronic heart failure (CHF) is a common syndrome characterized by several central hemodynamic and peripheral vascular and muscle abnormalities including autonomic imbalance, neuro-hormonal over-activation and decreased oxidative status.
In patients suffering from CHF, exercise confers several beneficial effects on the cardiovascular and peripheral systems, mainly by continuous aerobic training. However, interval aerobic training has also been validated as an alternate form of training that increases the exercise capacity of patients who are in CHF.
Read more
Recent studies have suggested that resistance training alone or as a complementary program besides the traditionally aerobic continuous training might exert favorable effects. However, little it is known about the combined effects of interval and strength training in CHF patients.
Aim of this prospective randomized controlled study was to investigate the effects of combined interval and strength training comparing to interval training alone in CHF patients.
- Conditions
- Chronic Heart Failure
- Being tested
- Exercise training
- Keywords
- interval training, strength training, exercise capacity, chronic heart failure, Cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Interval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 40 min in the interval training group
Exercise trainingOther
Interval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 20 min and Strength training of the quadriceps, hamstrings, muscles of the shoulder and biceps brachialis for 20 min 3 times per week for 36 sessions
| Study group | Role | What they receive |
|---|---|---|
| Combined interval and strength training | Active comparator | CHF Pts randomly designed at the combined interval and strength training group Receives: Other: Exercise training |
| Aerobic interval training | Active comparator | CHF Patients that randomly designed to participate at the interval training group Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic exercise capacity
Measured: 3 months
Secondary outcomes (1)
Endothelial function, oxygen kinetics, ventilatory drive
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 posted19 Feb 2010 (estimated)
- Study startNov 2004
- Primary completionApr 2010
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- 40 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, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071629
- Sponsor's protocol ID
- UOA-2010
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2010
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Anagnostakou V, Chatzimichail K, Dimopoulos S, Karatzanos E, Papazachou O, Tasoulis A, Anastasiou-Nana M, Roussos C, Nanas S. Effects of interval cycle training with or without strength training on vascular reactivity in heart failure patients. J Card Fail. 2011 Jul;17(7):585-91. doi: 10.1016/j.cardfail.2011.02.009. Epub 2011 Apr 22.
PubMed 21703531Tasoulis A, Papazachou O, Dimopoulos S, Gerovasili V, Karatzanos E, Kyprianou T, Drakos S, Anastasiou-Nana M, Roussos C, Nanas S. Effects of interval exercise training on respiratory drive in patients with chronic heart failure. Respir Med. 2010 Oct;104(10):1557-65. doi: 10.1016/j.rmed.2010.03.009.
PubMed 20663654Bouchla A, Karatzanos E, Dimopoulos S, Tasoulis A, Agapitou V, Diakos N, Tseliou E, Terrovitis J, Nanas S. The addition of strength training to aerobic interval training: effects on muscle strength and body composition in CHF patients. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):47-51. doi: 10.1097/HCR.0b013e3181e174d7.
PubMed 20562711Gerovasili V, Drakos S, Kravari M, Malliaras K, Karatzanos E, Dimopoulos S, Tasoulis A, Anastasiou-Nana M, Roussos C, Nanas S. Physical exercise improves the peripheral microcirculation of patients with chronic heart failure. J Cardiopulm Rehabil Prev. 2009 Nov-Dec;29(6):385-91. doi: 10.1097/HCR.0b013e3181b4ca4e.
PubMed 19770806M.Kravari, I. Vasileiadis, V. Gerovasili, E. Karatzanos, A. Tasoulis, K. Kalligras, S. Drakos, S. Dimopoulos, M. Anastasiou-Nana, S. Nanas. Effects of a 3-month rehabilitation program on muscle oxygenation in congestive heart failure patients as assessed by NIRS. International Journal of Industrial Ergonomics 40(2): 212-217, 2010
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
- Aerobic Interval Training Versus Combined Aerobic Interval Training and Strength Training Effects in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01071629
- Acronym / sponsor ID
- UOA-2010
- Conditions
- Chronic Heart Failure
- Keywords
- interval training, strength training, exercise capacity, chronic heart failure, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 19 Feb 2010 (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 common syndrome characterized by several central hemodynamic and peripheral vascular and muscle abnormalities including autonomic imbalance, neuro-hormonal over-activation and decreased oxidative status.
In patients suffering from CHF, exercise confers several beneficial effects on the cardiovascular and peripheral systems, mainly by continuous aerobic training. However, interval aerobic training has also been validated as an alternate form of training that increases the exercise capacity of patients who are in CHF.
Recent studies have suggested that resistance training alone or as a complementary program besides the traditionally aerobic continuous training might exert favorable effects. However, little it is known about the combined effects of interval and strength training in CHF patients.
Aim of this prospective randomized controlled study was to investigate the effects of combined interval and strength training comparing to interval training alone in CHF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined interval and strength training | Active comparator | Other: Exercise trainingCHF Pts randomly designed at the combined interval and strength training group |
| Aerobic interval training | Active comparator | Other: Exercise trainingCHF Patients that randomly designed to participate at the interval training group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable systolic heart failure
- NYHA functional class ≤ III
- Optimal medical treatment
Key exclusion criteria (2 listed)
- Contraindications for a maximal cardiopulmonary exercise testing (CPET) according to the American Thoracic Society/American College of Chest Physicians Statement
- Moderate to severe COPD
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 |
|---|---|---|
| Exercise trainingInterval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 40 min in the interval training group | Other | Aerobic interval training |
| Exercise trainingInterval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 20 min and Strength training of the quadriceps, hamstrings, muscles of the shoulder and biceps brachialis for 20 min 3 times per week for 36 sessions | Other | Combined interval and strength training |
Primary outcome
Aerobic exercise capacity
Time frame: 3 months
1 secondary outcome
Endothelial function, oxygen kinetics, ventilatory drive
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.
- Results publication: PubMed 21703531Anagnostakou V, Chatzimichail K, Dimopoulos S, Karatzanos E, Papazachou O, Tasoulis A, Anastasiou-Nana M, Roussos C, Nanas S. Effects of interval cycle training with or without strength training on vascular reactivity in heart failure patients. J Card Fail. 2011 Jul;17(7):585-91. doi: 10.1016/j.cardfail.2011.02.009. Epub 2011 Apr 22.
- Results publication: PubMed 20663654Tasoulis A, Papazachou O, Dimopoulos S, Gerovasili V, Karatzanos E, Kyprianou T, Drakos S, Anastasiou-Nana M, Roussos C, Nanas S. Effects of interval exercise training on respiratory drive in patients with chronic heart failure. Respir Med. 2010 Oct;104(10):1557-65. doi: 10.1016/j.rmed.2010.03.009.
- Results publication: PubMed 20562711Bouchla A, Karatzanos E, Dimopoulos S, Tasoulis A, Agapitou V, Diakos N, Tseliou E, Terrovitis J, Nanas S. The addition of strength training to aerobic interval training: effects on muscle strength and body composition in CHF patients. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):47-51. doi: 10.1097/HCR.0b013e3181e174d7.
- Results publication: PubMed 19770806Gerovasili V, Drakos S, Kravari M, Malliaras K, Karatzanos E, Dimopoulos S, Tasoulis A, Anastasiou-Nana M, Roussos C, Nanas S. Physical exercise improves the peripheral microcirculation of patients with chronic heart failure. J Cardiopulm Rehabil Prev. 2009 Nov-Dec;29(6):385-91. doi: 10.1097/HCR.0b013e3181b4ca4e.
- Results publicationM.Kravari, I. Vasileiadis, V. Gerovasili, E. Karatzanos, A. Tasoulis, K. Kalligras, S. Drakos, S. Dimopoulos, M. Anastasiou-Nana, S. Nanas. Effects of a 3-month rehabilitation program on muscle oxygenation in congestive heart failure patients as assessed by NIRS. International Journal of Industrial Ergonomics 40(2): 212-217, 2010
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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 principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Chronic 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 3 inclusion and 2 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 (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 NCT01071629, which also lists 5 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; AzTrials last refreshed its copy on 28 Oct 2026.