Predictors of Increased Physical Activity in Patients Receiving Physical Activity on Prescription

Physical Activity Clinical Trial

Official title:

Which Primary Care Patients Benefit From Physical Activity on Prescription? An Analysis of Factors Predicting Increased Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586011
• Other study ID #: Predictor study 206151
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: May 2, 2019

Study information

• Verified date: June 2019
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: May 2, 2019
• Est. primary completion date: August 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• Metabolic Syndrome
• Metabolic Syndrome X
• Physical Activity
• Primary Health Care

Intervention

Behavioral:
• Predicting factors for increased physical activity

Locations

Country	Name	City	State
Sweden	Närhälsan Göteborg centrum för fysisk aktivitet	Gothenburg	Region Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Self-efficacy expectations - Self-Efficacy for Exercise Scale (SEE)	Questionnaire focusing on the ability to exercise for 20 minutes, three times per week in the face of barriers to exercise. The questionnaire is culturally adopted, translated into Swedish, and includes nine items (e.g. "The weather was bothering you", "You had to exercise alone", "You felt depressed"), rated on an ordinal 10 point scale ranging from 1 (Not confident) to 10 (Very confident). The item scores are summarized and divided by the number of responses indicating the strength of self-efficacy expectations. The SEE has been tested for older adults and older women post-hip fracture displaying high internal consistency, acceptable reliability measured with squared multiple correlation coefficients and sufficient to strong evidence for construct- and criterion validity.	Association between baseline value of secondary outcome and 6-month value of primary outcome.
Secondary	Outcome expectations - Outcome Expectations for Exercise-2 Scale (OEE-2)	A 13-item measure with 9 positive worded items (e.g. "Helps me feel less tired") and 4 negatively worded items (e.g. "Is something I avoid because it causes me to be short of breath") divided into two subscales: positive OEE and negative OEE. The items are rated on a 5 point Likert scale ranging from 1 (Strongly agree) to 5 (Strongly disagree). The negative OEE items are reversed scored and the numerical ratings for each response are summarized and divided by the number of items. The OEE-2 questionnaire was revised in year 2005 to include 4 items concerning negative expectations with exercise based on qualitative findings and has shown some evidence for convergent validity, internal consistency and person-, item reliability.	Association between baseline value of secondary outcome and 6-month value of primary outcome.
Secondary	Enjoyment - Physical Activity Enjoyment Scale (PACES)	Consists of 16 items whereof 9 positively worded (e.g." I think it´s fun", "It gives me energy", "It is very pleasant") and 7 negatively worded (e.g. "I feel bored", "I don´t like it", "It´s frustrating for me"). Each item is rated on a 5 point Likert scale from 1 (Does not apply at all) to 5 (Truly applies), the negatively worded items are reversed scored and the responses are added to a score ranging from 16 to 80. The PACES has been tested for 18-24 year old students and adults with functional limitations showing acceptable test-retest reliability, internal consistency and criterion validity correlated to physical function.	Association between baseline value of secondary outcome and 6-month value of primary outcome.
Secondary	Social support - Social support for exercise scale (SSES)	Including 13 items, divided in a family and friends part and measured on a 5 point Likert scale. Eleven items are positively worded (participation and involvement) and two items negatively (rewards and punishments) describing social interactions possibly linked to exercise behaviour during the previous three months. Responses were ranged from 1 (none) to 5 (very often) and "not applicable" was given a score of 1. The item scores are summarized in three subgroups: Family support - positive, Friend support - positive and Family support - negative. The Friend support - negative subgroup scores were excluded by Sallis et al. because it did not emerge in the factor analysis. The SSES has shown acceptable test-retest reliability, high internal consistency and significant criterion validity correlated with a vigorous exercise measure.	Association between baseline value of secondary outcome and 6-month value of primary outcome.
Secondary	The readiness to change PA level	Measured at baseline including three questions estimated on a 100 mm visual analogue scale (VAS): How prepared are you? How important is it for you? How confident are you to succeed (self-efficacy)? The VAS line is anchored in each ends with words describing the minimal respectively maximal extremes of the dimension being measured. The questions derives from MI and behaviour change counselling according to Rollnick et al where a higher value on the VAS indicates increased readiness to change. VAS has been used in the social and behavior sciences both as a research and clinical tool and is considered to have acceptable reliability and validity.	Association between baseline value of secondary outcome and 6-month value of primary outcome.
Secondary	Body mass index - BMI	Calculated (kg/m2) from measured body weight, with light clothing and without shoes to the nearest 0.1 kg using an electric scale (Carl Lidén AFW D300, Jönköping, Sweden) and body height, measured in an upright position without shoes to the nearest 0.5 cm using a scale fixed to the wall (PEM 136, Hultafors, Sweden).	Association between baseline value of secondary outcome and 6-month value of primary outcome.
Secondary	Health related quality of life - the Swedish version of the Short Form 36 (SF-36 Standard Swedish Version 1.0)	Includes 36 questions and generates eight health concepts: physical functioning (PF), role physical functioning (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role emotional functioning (RE) and mental health (MH). The health concepts are converted to 0-100 points where higher values represents a better health-related quality of life. The different health concepts of SF-36 are also grouped into a physical component summary (PCS) and mental component summary (MCS) respectively. SF-36 has shown good to excellent internal consistency reliability and is validated in a representative sample of Swedish population.	Association between baseline value of secondary outcome and 6-month value of primary outcome.
Secondary	Socio demographic data.	Age (years), sex (female-male), social situation (single-married/cohabit-other), economy (good-neither nor-bad), education (elementary grade-upper secondary school-university college) and smoking (yes-previous-no) were also measured.	Association between baseline value of secondary outcome and 6-month value of primary outcome.