Physical Activity on Prescription in Patients With Metabolic Risk Factors.

NCT03012516 | Completed

• 1 other identifier: PAP-study RCT 206261
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate a one year intervention with physical activity on prescription (PAP) treatment for patients in a primary health care center setting versus an enhanced PAP-support with physiotherapist regarding physical activity (PA) level, metabolic health effects and health-related quality of life. One hundred ninety patients, 27-85 years, physically inactive, having at least one component of the metabolic syndrome and not responding with increased PA level after a 6-months PAP-treatment in primary health care centre are randomized to either enhanced support by physiotherapist (Intervention group) or continued ordinary PAP-treatment at the health care centre (Control group).

Conditions

Health Behavior; Activities of Daily Living; Metabolic Syndrome X; Quality of Life

Keywords

Physical Therapy Specialty; Exercise Test; Prescriptions; Counseling; Primary Health Care; Exercise

Outcome Measures

Primary Outcomes (4)

• 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 one year follow-up.

• Change in self-assessed PA-level - IPAQ

  The International physical activity questionnaire (IPAQ) assessing the level of PA during the last seven days. The instrument is extensively tested and translated into Swedish and vigorous-, moderate-intensity PA, walking and sitting time can be assessed.

  Change between baseline and one year follow-up.

• Change in self-assessed PA-level - SGPALS

  The Saltin-Grimby physical activity level scale (SGPALS) assessing leisure time PA during the past year in four different levels, from sedentary/physically inactive to vigorous physically active. The levels has been validated against e.g. metabolic risk factors and has been published in an updated Swedish form.

  Change between baseline and one year follow-up.

• Change in self-assessed PA-level - a six grade PA scale

  A six-grade PA scale is a further development of the SGPALS (Frändin/Grimby), and includes household activities. This scale correlates with physical performance and self-assessed fitness and is used to classify PA among elderly

  Change between baseline and one year follow-up.

Secondary Outcomes (10)

• Change in anthropometrics - Body mass index (BMI)

  Change between baseline and one year follow-up.

• Change in anthropometrics - Waist circumference (WC)

  Change between baseline and one year follow-up.

• Change in systolic blood pressure (SBP)

  Change between baseline and one year follow-up.

• Change in diastolic blood pressure (DBP)

  Change between baseline and one year follow-up.

• Change in blood samples - Plasma glucose after an overnight fast (FPG).

  Change between baseline and one year follow-up.

Study Arms (2)

PAP-treatment by physiotherapist.

EXPERIMENTAL

Enhanced PAP-support by physiotherapist including fitness test, individualized dialogue concerning PA, prescribed PAP and a 7 times follow-up during the one year intervention..

Behavioral: PAP-treatment by physiotherapist

Ordinary PAP-treatment at the health care centre.

ACTIVE COMPARATOR

Ordinary PAP-treatment at the health care centre including individualized dialogue concerning PA, prescribed PAP and an individually adjusted follow-up.

Behavioral: Ordinary PAP-treatment at the health care center

Interventions

PAP-treatment by physiotherapist BEHAVIORAL

PAP-treatment by physiotherapist.

Ordinary PAP-treatment at the health care center BEHAVIORAL

Ordinary PAP-treatment at the health care centre.

Eligibility Criteria

• Age: 27 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 NCEP classification.
• Receiving PAP-treatment.
• Understanding the Swedish language.

You may not qualify if:

• The patient decline to participate.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Närhälsan FaR-teamet centrala och västra Göteborg

Gothenburg, Region Västra Götaland, 421 44, Sweden

Location

Related Publications (19)

• Blair SN. Physical inactivity: the biggest public health problem of the 21st century. Br J Sports Med. 2009 Jan;43(1):1-2. No abstract available.

  PMID: 19136507 BACKGROUND

• Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.

  PMID: 3920711 BACKGROUND

• Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.

  PMID: 17762377 BACKGROUND

• Pavey TG, Taylor AH, Fox KR, Hillsdon M, Anokye N, Campbell JL, Foster C, Green C, Moxham T, Mutrie N, Searle J, Trueman P, Taylor RS. Effect of exercise referral schemes in primary care on physical activity and improving health outcomes: systematic review and meta-analysis. BMJ. 2011 Nov 4;343:d6462. doi: 10.1136/bmj.d6462.

  PMID: 22058134 BACKGROUND

• Orrow G, Kinmonth AL, Sanderson S, Sutton S. Effectiveness of physical activity promotion based in primary care: systematic review and meta-analysis of randomised controlled trials. BMJ. 2012 Mar 26;344:e1389. doi: 10.1136/bmj.e1389.

  PMID: 22451477 BACKGROUND

• Hallal PC, Lee IM. Prescription of physical activity: an undervalued intervention. Lancet. 2013 Feb 2;381(9864):356-7. doi: 10.1016/S0140-6736(12)61804-2. Epub 2012 Nov 28. No abstract available.

  PMID: 23199848 BACKGROUND

• Kallings LV, Sierra Johnson J, Fisher RM, Faire Ud, Stahle A, Hemmingsson E, Hellenius ML. Beneficial effects of individualized physical activity on prescription on body composition and cardiometabolic risk factors: results from a randomized controlled trial. Eur J Cardiovasc Prev Rehabil. 2009 Feb;16(1):80-4. doi: 10.1097/HJR.0b013e32831e953a.

  PMID: 19237997 BACKGROUND

• Leijon ME, Bendtsen P, Nilsen P, Festin K, Stahle A. Does a physical activity referral scheme improve the physical activity among routine primary health care patients? Scand J Med Sci Sports. 2009 Oct;19(5):627-36. doi: 10.1111/j.1600-0838.2008.00820.x. Epub 2008 Jul 8.

  PMID: 18627557 BACKGROUND

• Olsson SJ, Borjesson M, Ekblom-Bak E, Hemmingsson E, Hellenius ML, Kallings LV. Effects of the Swedish physical activity on prescription model on health-related quality of life in overweight older adults: a randomised controlled trial. BMC Public Health. 2015 Jul 21;15:687. doi: 10.1186/s12889-015-2036-3.

  PMID: 26193882 BACKGROUND

• Persson G, Ovhed I, Hansson EE. Simplified routines in prescribing physical activity can increase the amount of prescriptions by doctors, more than economic incentives only: an observational intervention study. BMC Res Notes. 2010 Nov 15;3:304. doi: 10.1186/1756-0500-3-304.

  PMID: 21078135 BACKGROUND

• 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.

  PMID: 25459975 BACKGROUND

• Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.

  PMID: 1329589 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Grimby G, Borjesson M, Jonsdottir IH, Schnohr P, Thelle DS, Saltin B. The "Saltin-Grimby Physical Activity Level Scale" and its application to health research. Scand J Med Sci Sports. 2015 Dec;25 Suppl 4:119-25. doi: 10.1111/sms.12611.

  PMID: 26589125 BACKGROUND

• Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.

  PMID: 11368702 BACKGROUND

• Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995 Nov;41(10):1349-58. doi: 10.1016/0277-9536(95)00125-q.

  PMID: 8560302 BACKGROUND

• Grimby G. Physical activity and muscle training in the elderly. Acta Med Scand Suppl. 1986;711:233-7. doi: 10.1111/j.0954-6820.1986.tb08956.x.

  PMID: 3535411 BACKGROUND

• Ryen L, Lundqvist S, Cider A, Borjesson M, Larsson MEH, Hagberg L. Cost-Effectiveness of Prolonged Physical Activity on Prescription in Previously Non-Complying Patients: Impact of Physical Activity Mediators. Int J Environ Res Public Health. 2023 Feb 21;20(5):3801. doi: 10.3390/ijerph20053801.

  PMID: 36900811 DERIVED

• Lundqvist S, Borjesson M, Cider A, Hagberg L, Ottehall CB, Sjostrom J, Larsson MEH. Long-term physical activity on prescription intervention for patients with insufficient physical activity level-a randomized controlled trial. Trials. 2020 Sep 15;21(1):793. doi: 10.1186/s13063-020-04727-y.

  PMID: 32933577 DERIVED

MeSH Terms

Conditions

Health Behavior; Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Åsa 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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 6, 2017
• Study Start: January 1, 2010
• Primary Completion: June 1, 2018
• Study Completion: September 15, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)