Supervised Exercise Compared to PAP in Patients With Permanent Atrial Fibrillation

NCT ID: NCT02493387

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-11-30

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 patient's 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 (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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Physical activity

Intervention Type: OTHER

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.

Interventions

Exercise

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

Intervention Type: OTHER

Physical activity

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asa Cider, Phd RPT

Role: STUDY_DIRECTOR

Institute of Neuroscience and Physiology/Physiotherapy

Locations

Sahlgrenska University Hospital and Alingsås Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

Goteborg Flimmer

Identifier Type: -

Identifier Source: org_study_id