Physiotherapist Led Group-exercise Compared Physical Acti... | NCT02493400

Studies
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription, a 3 Months Follow-up

NCT02493400

Sponsor

Göteborg University

Status

Completed

Last Update Posted

Feb 20, 2019Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

No intervention in the follow up study.

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Aug 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Jul 6, 2015

First Submission Date that Met QC Criteria

Jul 8, 2015

First Posted Date

Jul 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2019

Last Update Posted Date

Feb 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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, 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise group		A follow up from 3 months detraining from the exercise group. Patients follows their earlier randomisation.	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.	Other: No intervention in the follow up study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention in the follow up study.	Other		Active Comparator: PAP group Exercise group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical fitness	Working capacity in watt	3 months follow up

Secondary Outcomes

Measure	Description	Time Frame
Physical activity	accelerometer and questionnaire	3 months follow up
Health related quality of life	questionnaire short form (SF-36)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Patients who have completed the primary study will be offered a follow-up after 3 months

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asa Cider, Phd RPT	Institute of Neuroscience and Physiology/Physiotherapy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska university hospital and Alingsås hospital		Gothenburg			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D009043	Motor Activity

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided