Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02493387
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2015-07-06
Brief Title:
Supervised Exercise Compared to PAP in Patients With Permanent Atrial Fibrillation
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Should Elderly Patients With Atrial Fibrillation be Offered Physiotherapist Group Exercise or Can Physical Activity on Prescription PAP be Used as an Alternative
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atrial fibrillation is the most common arrhythmia and physical activity and exercise are sometimes avoided due to symptoms such as palpitations fatigue and anxiety Physiotherapist-led group based exercise as part of cardiac rehabilitation is rare for this group of patients the method physical activity on prescription is used to encourage the patient to increase their physical activity level in order to reduce the risk of premature morbidity and mortality However mostly in this method you do not know the patients ability to perform the prescribed amount of physical activity and its effect on physical fitness has not been studied in patients with heart disease neither has the effect of physiotherapist led group-based exercise in patients with atrial fibrillation The aim was to investigate the impact of physiotherapy led group-based exercise compared to physical activity on prescription in patients with atrial fibrillation regarding the level of physical fitness physical activity heart rate and health related quality of life HR-QoL
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 IPAQHR-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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None