- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02493387
Supervised Exercise Compared to PAP in Patients With Permanent Atrial Fibrillation
Should Elderly Patients With Atrial Fibrillation be Offered Physiotherapist Group Exercise or Can Physical Activity on Prescription (PAP) be Used as an Alternative
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ninety consecutive patients aged 65-85 years, visiting the cardiology clinic at Alingsås Hospital, Sahlgrenska University Hospital and primary care in the western part of Sweden will be asked to participate in the study. Inclusion criteria are permanent atrial fibrillation verified with electrocardiogram (ECG), left ventricular ejection fraction (EF) ≥ 45% and no significant valvular lesions verified by ultrasound. Exclusion criteria: Coronary event or angina pectoris within 3 months prior to inclusion, stroke with residual symptoms, presence of pacemaker or not able to participate in functional tests due to other disabilities, or to read Swedish. Physical fitness will be measured by a symptom limited bicycle test and a muscle endurance test. Physical activity will be measured by accelerometer and the International Physical Activity Questionnaire (IPAQ),HR-QoL will be measured by Short form (SF-36).
After the tests and return of accelerometer the patients will be randomized either to physiotherapist led group-based exercise or motivated interviewing and physical activity on prescription (PAP). The group-based exercise program consists of 60-minute sessions twice a week for 3 months, including central circulatory exercise performed on an ergometer cycle and muscle training, and two occasions of home-based exercise. The exercise program are designed after the patients requirements and with the intensity 13-17 on the Borg RPE 6-20 scale. The patients randomized to PAP will receive a PAP prescription and a physical activity diary. The PAP and physical activity diary will be followed up at 6 and 12 weeks after the inclusion. After three months all patients will perform the same tests as in baseline. A written informed consent will be obtained by the patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Göteborg, Sweden
- Sahlgrenska university hospital and Alingsås hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- permanent atrial fibrillation verified with electrocardiogram (ECG),
- left ventricular ejection fraction (EF) ≥ 45% and
- no significant valvular lesions verified by echocardiography
Exclusion Criteria:
- Coronary event or angina pectoris within 3 months prior to inclusion,
- stroke with residual symptoms,
- presence of pacemaker or
- not able to participate in functional tests due to other disabilities, or
- to read Swedish.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group
The group-based exercise program consists of 60-minute sessions twice a week for 3 months, including central circulatory exercise performed on an ergometer cycle and muscle training, and one or two occasions of home-based exercise.
The exercise program are designed after the patients requirements and with the intensity 13-17 on the RPE 6-20 scale
|
The group-based exercise program consists of 60-minute sessions twice a week for 3 months, including central circulatory exercise performed on an ergometer cycle and muscle training, and one or two occasions of home-based exercise.
The exercise program are designed after the patients requirements and with the intensity 13-17 on the Borg RPE 6-20 scale
|
Active Comparator: PAP group
The patients randomized PAP will receive a PAP prescription and a physical activity diary.
The PAP and physical activity diary will be followed up at 6 and 12 weeks after the inclusion.
|
The patients randomized PAP will receive a PAP prescription and a physical activity diary.
The PAP and physical activity diary will be followed up at 6 and 12 weeks after the inclusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical fitness
Time Frame: 3 months
|
Working capacity in watt
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: 3 months
|
Physical activity measured by accelerometer and questionnaire
|
3 months
|
Health related quality of life
Time Frame: 3 months
|
questionnaire Short form SF-36
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Asa Cider, Phd RPT, Institute of Neuroscience and Physiology/Physiotherapy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Goteborg Flimmer
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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