- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02493400
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription, a 3 Months Follow-up
February 18, 2019 updated by: Göteborg University
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription in Older Patients With Atrial Fibrillation, a 3 Months Follow-up
To investigate the effect of exercise or PAP prescription 3 months after completion of the study "Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative?"
regarding level of physical fitness, physical activity, heart rate and health related quality of life (HR-QoL).
Also if any of the investigated variables can predict the possible change in physical fitness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients who have completed study will be offered a follow-up after 3 months regarding physical fitness, physical activity, heart rate and HR-QoL.
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) and a physical activity diary, HR-QoL will be measured by short form (SF-36).
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Göteborg, Sweden
- Sahlgrenska university hospital and Alingsås hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have completed the primary study will be offered a follow-up after 3 months
Description
Inclusion Criteria:
- Completed the study "Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative?"
Exclusion Criteria:
- Not completed the above study or denied participation in follow up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Exercise group
A follow up from 3 months detraining from the exercise group.
Patients follows their earlier randomisation.
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Active Comparator: PAP group
A follow up from 3 months detraining from the active comparator group.
Patients follows their earlier randomisation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical fitness
Time Frame: 3 months follow up
|
Working capacity in watt
|
3 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: 3 months follow up
|
accelerometer and questionnaire
|
3 months follow up
|
|
Health related quality of life
Time Frame: 3 months follow up
|
questionnaire short form (SF-36)
|
3 months follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Asa Cider, Phd RPT, Institute of Neuroscience and Physiology/Physiotherapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
July 6, 2015
First Submitted That Met QC Criteria
July 8, 2015
First Posted (Estimate)
July 9, 2015
Study Record Updates
Last Update Posted (Actual)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Goteborg follow up flimmer
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