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NCT Number: NCT01617850

Efficacy of Physical Exercise in Cardiac Rehabilitation

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Heart Failure Ischemic Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy and Occupational therapy, Aarhus University Hospital, Skejby

Aarhus, Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised physical exercise training x3 weekly for 12 weeks

Other

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.

Supervised physical exercise training x2 weekly for 8 weeks

Other

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.

Primary outcomes

  1. 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

    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 outcomes

  1. Muscle strength

    Time frame: Changes from baseline in muscle strength at end of intervention (8 respectively 12 weeks)

    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 ®

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Institute for Clinical and Experimental Medicine

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2012
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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