NCT03586011

Brief Summary

The aim of this study is to explore possible predicting factors associated with physical activity (PA) level change in a 6-month period of physical activity on prescription (PAP) treatment. This is done in order to highlight potential predictors important for increased PA-level and to identify which primary care patients who may benefit from the PAP-intervention. Four hundred forty four patients are included in the study, 27-85 years, physically inactive, having at least one component of the metabolic syndrome (MetS) present and receiving PAP-treatment. Possible predicting factors of PA change at baseline and PA-level at 6-month follow-up are analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
Last Updated

April 15, 2020

Status Verified

June 1, 2019

Enrollment Period

4.6 years

First QC Date

July 2, 2018

Last Update Submit

April 14, 2020

Conditions

Keywords

Physical activity on prescriptionCorrelate of physical activityPredicting factor

Outcome Measures

Primary Outcomes (1)

  • Change in self-assessed PA-level according to the public health recommendation.

    Self-assessment of PA-level according to American college of sports medicine (ACSM) and American heart association (AHA) public health recommendation 2007. The patient responds to two PA questions, where 30 minutes of moderate-intensity PA per day results in 1 point and 20 minutes of more vigorous-intensity PA per day results in 1.7 point during each specific day of the week. A value of \<5 points indicates an inadequate PA level.

    Change between baseline and 6-month follow-up. Association between PA-level at 6-month follow-up and baseline value of secondary outcome.

Secondary Outcomes (8)

  • Self-efficacy expectations - Self-Efficacy for Exercise Scale (SEE)

    Association between baseline value of secondary outcome and 6-month value of primary outcome.

  • Outcome expectations - Outcome Expectations for Exercise-2 Scale (OEE-2)

    Association between baseline value of secondary outcome and 6-month value of primary outcome.

  • Enjoyment - Physical Activity Enjoyment Scale (PACES)

    Association between baseline value of secondary outcome and 6-month value of primary outcome.

  • Social support - Social support for exercise scale (SSES)

    Association between baseline value of secondary outcome and 6-month value of primary outcome.

  • The readiness to change PA level

    Association between baseline value of secondary outcome and 6-month value of primary outcome.

  • +3 more secondary outcomes

Interventions

Eligibility Criteria

Age27 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The 444 patients included in the study, are selected from 15 primary health care centres in Gothenburg, Sweden and are 27-85 years, physically inactive, having at least one component of the MetS present and receiving PAP-treatment. The patients have to understand the Swedish language to fill in the questionnaires.

You may qualify if:

  • Physically inactive according to ACSM/AHA public health recommendation from 2007.
  • Having at least one component of the metS present according to the National Cholesterol Education Program (NCEP) classification.
  • Receiving PAP-treatment.
  • Understanding the Swedish language.

You may not qualify if:

  • The patient decline to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Närhälsan Göteborg centrum för fysisk aktivitet

Gothenburg, Region Västra Götaland, 421 44, Sweden

Location

Related Publications (30)

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  • Lundqvist S, Borjesson M, Larsson MEH, Cider A, Hagberg L. Which patients benefit from physical activity on prescription (PAP)? A prospective observational analysis of factors that predict increased physical activity. BMC Public Health. 2019 May 2;19(1):482. doi: 10.1186/s12889-019-6830-1.

MeSH Terms

Conditions

Health BehaviorMotor ActivityMetabolic Syndrome

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ă…sa Cider, PhD

    Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, , Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 13, 2018

Study Start

January 1, 2010

Primary Completion

August 1, 2014

Study Completion

May 2, 2019

Last Updated

April 15, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Unidentifiable patient data for all primary and secondary outcome measures will be made available in a source data file (XLSX) in published article.

Time Frame
A source data file will be available in section "Supporting information" in published article.

Locations