Atrial FibrillationNCT02493400
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription, a 3 Months Follow-up
An observational study of Atrial Fibrillation, run by Göteborg University at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 87 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2014to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who have completed the primary study will be offered a follow-up after 3 months
Who may be able to join
- 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?"
Who cannot join
- Not completed the above study or denied participation in follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- No intervention in the follow up study.
- Keywords
- Follow up, Exercise, Rehabilitation
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in the follow up study.Other
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | A follow up from 3 months detraining from the exercise group. Patients follows their earlier randomisation. Receives: Other: No intervention in the follow up study. | |
| Active Comparator: PAP group | A follow up from 3 months detraining from the active comparator group. Patients follows their earlier randomisation. Receives: Other: No intervention in the follow up study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fitness
Working capacity in watt
Measured: 3 months follow up
Secondary outcomes (2)
Physical activity
accelerometer and questionnaire
Measured: 3 months follow up
Health related quality of life
questionnaire short form (SF-36)
Measured: 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asa Cider, Phd RPT, Study director, Institute of Neuroscience and Physiology/Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493400
- Sponsor's protocol ID
- Goteborg follow up flimmer
- Status last verified
- Feb 2019
- First submitted
- 6 Jul 2015
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapist Led Group-exercise Compared Physical Activity on Prescription in Older Patients With Atrial Fibrillation, a 3 Months Follow-up
- ClinicalTrials.gov ID
- NCT02493400
- Acronym / sponsor ID
- Goteborg follow up flimmer
- Conditions
- Atrial Fibrillation
- Keywords
- Follow up, Exercise, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | – | Other: No intervention in the follow up study.A follow up from 3 months detraining from the exercise group. Patients follows their earlier randomisation. |
| Active Comparator: PAP group | – | Other: No intervention in the follow up study.A follow up from 3 months detraining from the active comparator group. Patients follows their earlier randomisation. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who have completed the primary study will be offered a follow-up after 3 months
Key inclusion criteria (1 listed)
- 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?"
Key exclusion criteria (1 listed)
- Not completed the above study or denied participation in follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention in the follow up study. | Other | Active Comparator: PAP group, Exercise group |
Primary outcome
Physical fitness
Time frame: 3 months follow up
Working capacity in watt
2 secondary outcomes
Physical activity
Time frame: 3 months follow up
Health related quality of life
Time frame: 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asa Cider, Phd RPT study director
Institute of Neuroscience and Physiology/Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical fitness (time frame: 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.