NCT01071629

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

5.4 years

First QC Date

February 18, 2010

Last Update Submit

March 12, 2015

Conditions

Keywords

interval trainingstrength trainingexercise capacitychronic heart failureCardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Aerobic exercise capacity

    3 months

Secondary Outcomes (1)

  • Endothelial function, oxygen kinetics, ventilatory drive

    3 months

Study Arms (2)

Combined interval and strength training

ACTIVE COMPARATOR

CHF Pts randomly designed at the combined interval and strength training group

Other: Exercise training

Aerobic interval training

ACTIVE COMPARATOR

CHF Patients that randomly designed to participate at the interval training group

Other: Exercise training

Interventions

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

Aerobic interval training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable systolic heart failure
  • NYHA functional class ≤ III
  • Optimal medical treatment

You may not qualify if:

  • Contraindications for a maximal cardiopulmonary exercise testing (CPET) according to the American Thoracic Society/American College of Chest Physicians Statement
  • Moderate to severe COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, First Critical Care Unit, School of Medicine, National & Kapodistrian University of Athens

Athens, 10676, Greece

Location

Related Publications (5)

  • 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.

  • Tasoulis 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.

  • Bouchla 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.

  • Gerovasili 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.

  • M.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

    RESULT

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Serafim Nanas, MD

    University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

November 1, 2004

Primary Completion

April 1, 2010

Study Completion

September 1, 2015

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations