Efficacy of Physical Exercise in Cardiac Rehabilitation

NCT01617850 | Completed

• 1 other identifier: 20100297
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Heart Failure; Ischemic Heart Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Muscle strength

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

• VCAM-1

  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.

Study Arms (2)

optimized physical exercise training

EXPERIMENTAL

Intervention: Supervised physical exercise training x3 weekly for 12 weeks

Other: Supervised physical exercise training x3 weekly for 12 weeks

conventional group

ACTIVE COMPARATOR

Intervention: Supervised physical exercise training x2 weekly for 8 weeks

Other: Supervised physical exercise training x2 weekly for 8 weeks

Interventions

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.

optimized physical exercise training

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.

conventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Institute for Clinical and Experimental Medicine: collaborator

Study Sites (1)

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

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Coronary Disease; Heart Failure; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jens Christian Djuurhuus, professor,MD

  Institute of Clinical Medicine, Aarhus University, Department of Physio- and Occupationaltherapy, Aarhus University Hospital, Skejby

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor,PT, Ph.D

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 12, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

DK (1)