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OpenTrials
Completed

NCT Number: NCT02493387

Supervised Exercise Compared to PAP in Patients With Permanent Atrial Fibrillation

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital and Alingsås Hospital

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

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

Physical activity

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.

Primary outcomes

  1. Physical fitness

    Time frame: 3 months

    Working capacity in watt

Secondary outcomes

  1. Physical activity

    Time frame: 3 months

    Physical activity measured by accelerometer and questionnaire

  2. Health related quality of life

    Time frame: 3 months

    questionnaire Short form SF-36

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Should Elderly Patients With Atrial Fibrillation be Offered Physiotherapist Group Exercise or Can Physical Activity on Prescription (PAP) be Used as an Alternative

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2015
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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