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Efficacy of Physical Exercise in Cardiac Rehabilitation

Primary Purpose

Coronary Heart Disease, Heart Failure, Ischemic Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Supervised physical exercise training x3 weekly for 12 weeks
Supervised physical exercise training x2 weekly for 8 weeks
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

optimized physical exercise training

conventional group

Arm Description

Intervention: Supervised physical exercise training x3 weekly for 12 weeks

Intervention: Supervised physical exercise training x2 weekly for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 ®
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.

Full Information

First Posted
June 6, 2012
Last Updated
May 21, 2015
Sponsor
Aarhus University Hospital Skejby
Collaborators
Institute for Clinical and Experimental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01617850
Brief Title
Efficacy of Physical Exercise in Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Institute for Clinical and Experimental Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Heart Failure, Ischemic Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
optimized physical exercise training
Arm Type
Experimental
Arm Description
Intervention: Supervised physical exercise training x3 weekly for 12 weeks
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
Intervention: Supervised physical exercise training x2 weekly for 8 weeks
Intervention Type
Other
Intervention Name(s)
Supervised physical exercise training x3 weekly for 12 weeks
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised physical exercise training x2 weekly for 8 weeks
Intervention Description
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 Outcome Measure Information:
Title
Aerobic capacity measured as maximal oxygen uptake (V02 max)
Description
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.
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
Secondary Outcome Measure Information:
Title
Muscle strength
Description
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 ®
Time Frame
Changes from baseline in muscle strength at end of intervention (8 respectively 12 weeks)
Title
VCAM-1
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Christian Djuurhuus, professor,MD
Organizational Affiliation
Institute of Clinical Medicine, Aarhus University, Department of Physio- and Occupationaltherapy, Aarhus University Hospital, Skejby
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physiotherapy and Occupational therapy, Aarhus University Hospital, Skejby
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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Efficacy of Physical Exercise in Cardiac Rehabilitation

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