Physical Activity on Prescription and Enhanced Individual... | NCT04350983

Studies
Physical Activity on Prescription and Enhanced Individual Support by Physiotherapist

NCT04350983

Sponsor

Vastra Gotaland Region

Status

Completed

Last Update Posted

Apr 17, 2020Actual

Enrollment

331Actual

Phase

Not provided

Conditions

Physical Activity
Sedentary Behavior
Multimorbidity

Interventions

Increased physical activity

Countries

Not provided

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

Apr 2020

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

Jan 1, 2015Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Apr 1, 2020Actual

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 17, 2020Actual

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

Apr 16, 2020

Last Update Posted Date

Apr 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Multimorbidity is common, especially in the elderly population and is associated with a higher risk of mortality and disability, lower quality of life, polypharmacy, increased healthcare use and costs. Physical inactivity increases the risk of multimorbidity and individuals with multimorbidity are more likely to be physically inactive. Physical activity can prevent and treat several diseases. Physical Activity on Prescription (PAP) is an evidence-based method used in health care to increase physical activity. The aim of this study was to investigate whether self-reported physical activity level increase and sedentary time decreases in individuals who have received PAP in health care completed with enhanced individual support by physiotherapist at PAP-reception in wellness center for six months and to compare individuals with one diagnosis to individuals with multimorbidity.

The study population consisted of 331 adults who received PAP in health care and enhanced individual support by a physiotherapist at PAP-reception during six months. Data has been collected retrospectively from a local register with questionnaires from the PAP-reception. Self reported physical activity minutes/week and hours of sedentary time/day were measured at baseline and at six months. Differences in physical activity minutes and sedentary time from baseline to six months have been compared between individuals with one diagnosis and individuals with multimorbidity.

Detailed Description

Not provided

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

331Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Increased physical activity	Behavioral	PAP and enhanced individual support by physiotherapist to increase physical activity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical activity minutes/week	Self-assessment of two physical activity questions	Change between baseline and six months follow up.
Sedentary time hours/day	Self-assessment of one sedentary behaviour question	Change between baseline and six months follow up.

Secondary Outcomes

Measure	Description	Time Frame
Diagnoses	Type and number of diagnoses	Measured at baseline
Visits and telephone contacts	Number of visits and telephone contacts

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Received physical activity on prescription from health care
Contact with PAP-reception

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

93 Years

Standard Ages

AdultOlder Adult

Study Population

The study population consists of men and women aged 20-93 years who received PAP from health care and enhanced individual support by physiotherapist at PAP-reception in wellness centre in central and western Gothenburg in 2015-2016. The majority of the study population had a multimorbidity and the most common diagnosis was musculoskeletal disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Larsson, PhD	Sahlgrenska academy, University of Gothenburg	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data that supports the findings of this study are available from the corresponding author on reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D057185	Sedentary Behavior

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided