Efficacy of Physical Exercise in Cardiac Rehabilitation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Institute for Clinical and Experimental Medicine
Information provided by (Responsible Party):
Mette Krintel Petersen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01617850
First received: June 6, 2012
Last updated: June 18, 2014
Last verified: June 2014
  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. Furthermore, recent studies have shown that physical cardiac exercise training can influence inflammation of the vessel wall and hence reduce development of arteriosclerosis in coronary vessels. In the literature are divergent conclusions on appropriate frequency and duration of physical rehabilitation programs in order to improve physical function and reduce arteriosclerosis.

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 in aerobic capacity between baseline and end of intervention (8 respectively 12 weeks). Follow-up data 6 and 12 month after end of intervention ] [ Designated as safety issue: No ]

    Cardiopulmonary exercise testing (CPX) using breath by breath gas-analysis 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.



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 ®


  • VCAM-1 [ Time Frame: Changes in VCAM-1(pg/ml) between baseline and end of intervention (8 respectively 12 weeks). Follow-up 6 and 12 month after end of intervention. ] [ 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.


Estimated Enrollment: 70
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: optimized physical exercise training
Intervention: Supervised physical exercise training x3 weekly for 12 weeks
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
Intervention: Supervised physical exercise training x2 weekly for 8 weeks
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.

Detailed Description:

Both trial groups carry out physical exercise training in groups. The exercise training is instructed by two physiotherapists with expertise in cardiac rehabilitation. Each training session takes 60 minutes and is based on current evidence for physical training for IHD and CHF patients. Exercise intensity progresses within the first week of the training program from moderate intensity (40-59% of VO2max), to high intensity (60-84% of VO2max). Exercise intensity of the individual training sessions is monitored by heart rate.

The training program includes the following:

Warm-up and stretching: Each training sessions starts 10 min. warm-up and ends with 5 min. stretching.

Aerobic exercise : Takes place on treadmill, stairs, ergometer bikes and interval training with different strength-endurance exercises.

Muscle strength: Is performed on machines with weight training equipment or by floor exercises. 10-15 repetitions are performed with a load equivalent to 50-60% of 1 RM.

The exercise programs for both groups are performed using a standardized exercise protocol.

All patients per a sub-maximal and a maximal exercise test prior to participation in the physical exercise training program.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617850

Locations
Denmark
Department of Physiotherapy and Occupational therapy, Aarhus University Hospital, Skejby
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
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, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01617850     History of Changes
Other Study ID Numbers: 20100297
Study First Received: June 6, 2012
Last Updated: June 18, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on October 20, 2014