AzTrials
AzTrials

Health BehaviorNCT03586011

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

An observational study of Health Behavior and Physical Activity, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 27 to 85 years
What is being tested?
Predicting factors for increased physical activity
How many people
444 participants
Where
1 siteSweden
Study dates
1 Jan 2010to 2 May 2019
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 27 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • The patient decline to participate.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Närhälsan Göteborg centrum för fysisk aktivitet

    Gothenburg, Region Västra Götaland, 421 44

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Predicting factors for increased physical activity
Keywords
Physical activity on prescription, Correlate of physical activity, Predicting factor
Medical subject headings
Health Behavior, Motor Activity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Predicting factors for increased physical activityBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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).

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

  7. 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.

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

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2018
  2. Study start1 Jan 2010
  3. Primary completion1 Aug 2014
  4. Study completion2 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
444 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03586011
Sponsor's protocol ID
Predictor study 206151
Status last verified
Jun 2019
First submitted
2 Jul 2018
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unidentifiable patient data for all primary and secondary outcome measures will be made available in a source data file (XLSX) in published article.

Publications

  • Das P, Horton R. Rethinking our approach to physical activity. Lancet. 2012 Jul 21;380(9838):189-90. doi: 10.1016/S0140-6736(12)61024-1. No abstract available.

    PubMed 22818931

  • Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.

    PubMed 14744958

  • Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.

    PubMed 22818936

  • Wen CP, Wai JP, Tsai MK, Yang YC, Cheng TY, Lee MC, Chan HT, Tsao CK, Tsai SP, Wu X. Minimum amount of physical activity for reduced mortality and extended life expectancy: a prospective cohort study. Lancet. 2011 Oct 1;378(9798):1244-53. doi: 10.1016/S0140-6736(11)60749-6. Epub 2011 Aug 16.

    PubMed 21846575

  • Hagberg LA, Lindahl B, Nyberg L, Hellenius ML. Importance of enjoyment when promoting physical exercise. Scand J Med Sci Sports. 2009 Oct;19(5):740-7. doi: 10.1111/j.1600-0838.2008.00844.x. Epub 2008 Aug 5.

    PubMed 18694433

  • Joy EL, Blair SN, McBride P, Sallis R. Physical activity counselling in sports medicine: a call to action. Br J Sports Med. 2013 Jan;47(1):49-53. doi: 10.1136/bjsports-2012-091620. Epub 2012 Nov 13.

    PubMed 23149653

  • Persson G, Brorsson A, Ekvall Hansson E, Troein M, Strandberg EL. Physical activity on prescription (PAP) from the general practitioner's perspective - a qualitative study. BMC Fam Pract. 2013 Aug 29;14:128. doi: 10.1186/1471-2296-14-128.

    PubMed 23987804

  • Sallis R, Franklin B, Joy L, Ross R, Sabgir D, Stone J. Strategies for promoting physical activity in clinical practice. Prog Cardiovasc Dis. 2015 Jan-Feb;57(4):375-86. doi: 10.1016/j.pcad.2014.10.003. Epub 2014 Oct 22.

    PubMed 25459975

  • Bauman AE, Sallis JF, Dzewaltowski DA, Owen N. Toward a better understanding of the influences on physical activity: the role of determinants, correlates, causal variables, mediators, moderators, and confounders. Am J Prev Med. 2002 Aug;23(2 Suppl):5-14. doi: 10.1016/s0749-3797(02)00469-5.

    PubMed 12133733

  • Baranowski T, Anderson C, Carmack C. Mediating variable framework in physical activity interventions. How are we doing? How might we do better? Am J Prev Med. 1998 Nov;15(4):266-97. doi: 10.1016/s0749-3797(98)00080-4.

    PubMed 9838973

  • Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.

    PubMed 3806354

  • Bauman AE, Reis RS, Sallis JF, Wells JC, Loos RJ, Martin BW; Lancet Physical Activity Series Working Group. Correlates of physical activity: why are some people physically active and others not? Lancet. 2012 Jul 21;380(9838):258-71. doi: 10.1016/S0140-6736(12)60735-1.

    PubMed 22818938

  • Stott NC, Rollnick S, Rees MR, Pill RM. Innovation in clinical method: diabetes care and negotiating skills. Fam Pract. 1995 Dec;12(4):413-8. doi: 10.1093/fampra/12.4.413.

    PubMed 8826057

  • Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.

    PubMed 10882320

  • Resnick B. Reliability and validity of the Outcome Expectations for Exercise Scale-2. J Aging Phys Act. 2005 Oct;13(4):382-94. doi: 10.1123/japa.13.4.382.

    PubMed 16301750

Questions about this trial

What is this clinical trial studying?

An observational study of Health Behavior and Physical Activity, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-assessed PA-level according to the public health recommendation. (time frame: Change between baseline and 6-month follow-up. Association between PA-level at 6-month follow-up and baseline value of secondary outcome.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03586011, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.

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