Clinical trial NCT03586011: Predictors of Increased Physical Activity in Patients Receiving Physical Activity on Prescription
Official title: Which Primary Care Patients Benefit From Physical Activity on Prescription? An Analysis of Factors Predicting Increased Physical Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Physical Activity
Metabolic Syndrome X
Primary Health Care
Keywords: Physical activity on prescription
Correlate of physical activity
Predicting factor
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-07-13
Enrollment: 444
Sex: ALL
Minimum age (years): 27
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: Aim:

To explore possible predicting factors associated with PA-level change in a 6-month period of 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.

Methods:

Study design:

This is a longitudinal prospective observational cohort study with a 6-month follow-up of PAP-treatment. The treatment is carried out as part of a daily clinical primary care practice.

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.

Intervention:

The PAP-treatment is offered by authorized personnel, educated in PA-effects and PAP-intervention and consists of an individual-based dialogue with the patient, an individually tailored recommendation of PA including a written prescription, and customized, structured support during 6 months. The patients health status, previous respectively current PA level, preferences for different physical activities, motivation, self-efficacy and readiness to change PA behavior are evaluated. An agreed individually dosed PA is written down and the support during the 6-month intervention is individually structured either by revisits or by telephone contacts.

Measurements:

The following measurements are conducted at baseline and the 6-month follow-up: PA-level, self-efficacy expectations, outcome expectations, enjoyment, social support, readiness to change PA, body mass index (BMI), and health related quality of life. Age, sex, social situation, economy, education, and smoking is also measured.

Statistical analysis:

A per-protocol analysis is used. In the predictor analysis, Spearman rank correlation and a univariate regression analysis is used, respectively, to examine the association between possible predicting factors at baseline and PA level at 6-month follow-up. Significant predictors from the regression analysis are dichotomized into positive and negative values, respectively, and a Chi-square test for independence is used in analysing the predictors at baseline to increased PA level at 6-month follow-up. Statistical significance is set at p ≤0.05.

Hypothesis:

It is possible finding predicting factors among the patient´s answers according to self-reported questionnaires for the purpose of identifying responders/non-responders to increased physical activity level at 6 month follow-up of PAP-treatment.

Clinical implication:

Highlighting possible predicting factors to increased PA in an early stage of PAP-intervention, offers the opportunity to support the patient in the behavioural change process and to individualize the PAP-treatment, with the aim to increase physical activity level.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* The patient decline to participate.

Primary outcomes:
measure: Change in self-assessed PA-level according to the public health recommendation.
timeFrame: 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:
measure: Self-efficacy expectations - Self-Efficacy for Exercise Scale (SEE)
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
measure: Outcome expectations - Outcome Expectations for Exercise-2 Scale (OEE-2)
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
measure: Enjoyment - Physical Activity Enjoyment Scale (PACES)
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
measure: Social support - Social support for exercise scale (SSES)
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
measure: The readiness to change PA level
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
measure: Body mass index - BMI
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
measure: Health related quality of life - the Swedish version of the Short Form 36 (SF-36 Standard Swedish Version 1.0)
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
measure: Socio demographic data.
timeFrame: Association between baseline value of secondary outcome and 6-month value of primary outcome.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Närhälsan Göteborg centrum för fysisk aktivitet
state: Region Västra Götaland
Study officials:
affiliation: Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, , Gothenburg, Sweden
name: Åsa Cider, PhD
role: PRINCIPAL_INVESTIGATOR
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