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Supervised Exercise Compared to PAP in Patients With Permanent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise
Physical activity
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Physiotherapist led group-based exercise, Physical activity, Atrial fibrillation

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sahlgrenska University Hospital and Alingsås Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise group

PAP group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Physical fitness
Working capacity in watt

Secondary Outcome Measures

Physical activity
Physical activity measured by accelerometer and questionnaire
Health related quality of life
questionnaire Short form SF-36

Full Information

First Posted
July 6, 2015
Last Updated
November 9, 2018
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT02493387
Brief Title
Supervised Exercise Compared to PAP in Patients With Permanent Atrial Fibrillation
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Physiotherapist led group-based exercise, Physical activity, Atrial fibrillation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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
Arm Title
PAP group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Name(s)
Physical activity
Intervention Description
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 Outcome Measure Information:
Title
Physical fitness
Description
Working capacity in watt
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Physical activity
Description
Physical activity measured by accelerometer and questionnaire
Time Frame
3 months
Title
Health related quality of life
Description
questionnaire Short form SF-36
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asa Cider, Phd RPT
Organizational Affiliation
Institute of Neuroscience and Physiology/Physiotherapy
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital and Alingsås Hospital
City
Göteborg
Country
Sweden

12. IPD Sharing Statement

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Supervised Exercise Compared to PAP in Patients With Permanent Atrial Fibrillation

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