Efficacy of Physical Exercise in Cardiac Rehabilitation

This study is currently recruiting participants.
Verified June 2012 by Aarhus University Hospital Skejby
Sponsor:
Collaborator:
Institute for Clinical and Experimental Medicine
Information provided by (Responsible Party):
Mette Krintel Petersen, Skejby Hospital
ClinicalTrials.gov Identifier:
NCT01617850
First received: June 6, 2012
Last updated: June 9, 2012
Last verified: June 2012
  Purpose

Physical rehabilitation is a key element in the treatment of patients with cardiovascular diseases, and recent evidence has shown that supervised exercise programmes can prevent cardiovascular events, improve physical function and quality of life. Individualized exercise prescription based on appropriate frequency, intensity and duration is recommended. Recent studies have shown that physical exercise can lower levels of biomarkers who can influence inflammation of the vessel wall and hence development of arteriosclerosis in coronary vessels. In the literature are divergent conclusions on appropriate frequency and duration of physical rehabilitation programmes.

The purpose of this study is to investigate the efficacy of an optimized physical rehabilitation programme compared to a conventional programme on physical fitness, health related quality of life and vascular inflammation.


Condition Intervention
Coronary Heart Disease
Heart Failure
Ischemic Heart Diseases
Other: Supervised physical exercise training x3 weekly for 12 weeks
Other: Supervised physical exercise training x2 weekly for 8 weeks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Aerobic capacity measured as maximal oxygen uptake (V02 max) [ Time Frame: Changes from baseline in aerobic capacity at end of intervention (8 respectively 12 weeks) ] [ Designated as safety issue: No ]

    Cardiopulmonary exercise testing (CPX) using breath by breath gasanalysis measures variables related to cardiorespiratory function, including expiratory ventilation and pulmonary gas exchange (oxygen uptake (VO2) and carbon dioxide (VCO2). Along with the ECG, heart rate and blood pressure these measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise. The standard expression of aerobic working capacity is the maximum VO2.

    VO2 max reached during a symptom-limited incremental CPX protocol is commonly expressed as O2 per kg-1 per min -1.


  • VCAM-(1pg/ml) [ Time Frame: Changes from baseline in VCAM-(1pg/ml) at end of intervention (8 respectively 12 weeks) ] [ Designated as safety issue: No ]
    VCAM-1 is an endothelial cell protein, which is gate, when leukocytes reside on the intima of the vessel wall. TNF-alpha stimulates endothelial cell to membrane expression of VCAM-1, where leukocytes can adhere to endothelial cell s and influence inflammation of the vessel wall. VCAM-1 is thus a specific inflammation marker in the vessel wall, and hence development of arteriosclerosis in coronary vessels.


Secondary Outcome Measures:
  • Muscle strength [ Time Frame: Changes from baseline in muscle strength at end of intervention (8 respectively 12 weeks) ] [ Designated as safety issue: No ]

    Isometric muscle strength and muscle power are essential determinants for physical performance. Maximal isometric muscle strength is defined as a maximal volunteer contraction at a specific range of motion, and muscle power as the ability to produce high force rapidly.

    Isometric volunteer knee extension is measured with the patients sitting in a adjustable dynamometer chair (Good Muscle Strength, Metittur®) and measurement of leg extensor power is measured using a Nottingham Power Rig ®



Estimated Enrollment: 70
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: optimized group Other: Supervised physical exercise training x3 weekly for 12 weeks
Physical exercise training 1 hour per session. The exercise rehabilitation programme is carried out as group training with individual supervision. At each exercise session two experienced physiotherapist are leading the physical exercise training. Standardized physical exercise guidelines for each training session is described and followed. It consists of the following interventions: Warm up, aerobe fitness, muscle strength training and individual education and instruction in life stills changes in relation to physical activity.
Active Comparator: conventional group Other: Supervised physical exercise training x2 weekly for 8 weeks
Physical exercise training is carried out for 1 hour per session. The exercise rehabilitation programme is carried out as group training with individual supervision. At each exercise session two-experienced physiotherapist are leading the physical exercise training. Standardized physical exercise guidelines for each training session is described and followed. It consists of the following interventions: Warm up, aerobe fitness, muscle strength training and individual education and instruction in life stills changes in relation to physical activity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients prescribed to physical exercise training at Skejby University Hospital with:

  • stable and unstable angina pectoris,
  • acute myocardial infarction with and without ECG changes
  • chronic heart failure

Exclusion Criteria:

  • patients with BMI>35
  • patients with musculoskeletal or neurological diseases that unable them to participate in physical exercise training programmes
  • patients who can not read or understand danish language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617850

Contacts
Contact: Mette K Petersen, M.Sc, Ph.d 78456719 ext 0045 annempte@rm.dk
Contact: Sussie Laustsen, MNS, Ph.D 78 459 030 ext 0045 sussie.laustsen@ki.au.dk

Locations
Denmark
Department of Physiotherapy and Occupational therapy, Aarhus University Hospital, Skejby Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Mette K Petersen, MsC, Ph.D    78456719 ext 0045    annempte@rm.dk   
Contact: Sussie Laustsen, MNS, Ph.D    78 459 030 ext 0045    sussie.laustsen@ki.au.dk   
Sponsors and Collaborators
Skejby Hospital
Institute for Clinical and Experimental Medicine
Investigators
Study Chair: Jens Christian Djuurhuus, professor,MD Institute of Clinical Medicine, Aarhus University, Department of Physio- and Occupationaltherapy, Aarhus University Hospital, Skejby
  More Information

No publications provided

Responsible Party: Mette Krintel Petersen, assistant professor,PT, Ph.D, Skejby Hospital
ClinicalTrials.gov Identifier: NCT01617850     History of Changes
Other Study ID Numbers: 20100297
Study First Received: June 6, 2012
Last Updated: June 9, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Failure
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014