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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Coronary Heart Disease; Ischemic Heart Diseases
• Intervention / Treatment: Other: Supervised physical exercise training x3 weekly for 12 weeks; Other: Supervised physical exercise training x2 weekly for 8 weeks

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Department of Physiotherapy and Occupational therapy, Aarhus University Hospital, Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capacity measured as maximal oxygen uptake (V02 max)	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	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 ®	Changes from baseline in muscle strength at end of intervention (8 respectively 12 weeks)
VCAM-1	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.	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.

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 9, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 20100297