NCT02493387

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

5.4 years

First QC Date

July 6, 2015

Last Update Submit

November 9, 2018

Conditions

Atrial Fibrillation

Keywords

Physiotherapist led group-based exercisePhysical activityAtrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Physical fitness

    Working capacity in watt

    3 months

Secondary Outcomes (2)

  • Physical activity

    3 months

  • Health related quality of life

    3 months

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Other: Exercise

PAP group

ACTIVE COMPARATOR

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.

Other: Physical activity

Interventions

ExerciseOTHER

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

Exercise group
Physical activityOTHER

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.

PAP group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • permanent atrial fibrillation verified with electrocardiogram (ECG),
  • left ventricular ejection fraction (EF) ≥ 45% and
  • no significant valvular lesions verified by echocardiography

You may not qualify if:

  • stroke with residual symptoms,
  • presence of pacemaker or
  • not able to participate in functional tests due to other disabilities, or
  • to read Swedish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital and Alingsås Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Atrial FibrillationMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Asa Cider, Phd RPT

    Institute of Neuroscience and Physiology/Physiotherapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 9, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2018

Study Completion

November 1, 2018

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations

SE(1)