Clinical trial NCT01617850: Efficacy of Physical Exercise in Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Heart Failure
Ischemic Heart Diseases
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Institute for Clinical and Experimental Medicine
First posted: 2012-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Aerobic capacity measured as maximal oxygen uptake (V02 max)
timeFrame: 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 outcomes:
measure: Muscle strength
timeFrame: Changes from baseline in muscle strength at end of intervention (8 respectively 12 weeks)
measure: VCAM-1
timeFrame: 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.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Physiotherapy and Occupational therapy, Aarhus University Hospital, Skejby
state: Aarhus N
Study officials:
affiliation: Institute of Clinical Medicine, Aarhus University, Department of Physio- and Occupationaltherapy, Aarhus University Hospital, Skejby
name: Jens Christian Djuurhuus, professor,MD
role: STUDY_CHAIR
References: