Health BehaviorNCT03012516

Physical Activity on Prescription in Patients With Metabolic Risk Factors.

A study testing PAP-treatment by physiotherapist and Ordinary PAP-treatment at the health care center in people with Health Behavior and Activities of Daily Living, 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

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 27 to 85 years
Conditions the study is for: Health Behavior, Activities of Daily Living, Metabolic Syndrome X
What is being tested?: PAP-treatment by physiotherapist and Ordinary PAP-treatment at the health care center
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 190 participants
Where: 1 siteSweden
Study dates: Jan 2010to 15 Sep 2020
Phase: Interventional
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

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 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 FaR-teamet centrala och västra Göteborg
Gothenburg, Region Västra Götaland, 421 44

Other trials in Sweden

About this study

Official title: Physical Activity on Prescription With Two Different Strategies. One Year Follow-up Regarding Physical Activity Level, Metabolic Health and Health-related Quality of Life. A Randomized Controlled Trial.

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).

Read the detailed description

Aim:

The aim is to evaluate whether an enhanced support with physiotherapist for patients who are non-responders to PAP-treatment at 6 months follow-up in a primary health care centre setting influences physical activity level, metabolic health effects and health-related quality of life.

Methods:

Study design:

This is a randomized controlled trial (RCT) with two arms: one intervention group and one control group. The present study is part of an ongoing study including 444 patients with a 5 years follow-up.

Study population:

The study population includes 190 patients, 27-85 years, having at least on component of the metabolic syndrome (metS) and non-responding to PAP-treatment initiated at health care centre. The patients randomizes to either enhanced PAP-support by physiotherapist (Intervention group n = 98) or continued ordinary PAP-treatment at the health care centre (Control group n = 92).

Intervention:

In the control group, PAP-treatment is offered by authorized personnel, mainly nurses and includes an individualized dialogue concerning PA, prescribed PAP and an individually adjusted follow-up. The intervention by physiotherapist includes fitness test using an ergometer bicycle. The result from the ergometer bicycle test forms the basis for a continuing motivating dialogue concerning physical activity and an individually dosed physical activity regarding frequence, duration and intensity with a prescribed PAP. The patient is supported by physiotherapist 7 times during the one year intervention.

Measurements:

For both groups, the patients PA-level, metabolic health and health related quality of life is measured at baseline and one-year follow-up, at the health care centre. In the intervention group, the ergometer bicycle test is conducted by the physiotherapist.

Statistical analysis:

The size of the study is calculated based on a power of 90%, to detect a difference of 20% in physical activity level between the intervention (40% responders) and control (20% responders) groups referred to physical activity level ≥5 points, at a significance level of 0.05. Intention-to-treat analysis will be used. Data will be processed using Paired samples t-test or Wilcoxon sign-rank test based on data level in within group analyses. Analyses between intervention and control group will be performed using Independent samples t-test or Mann Whitney U-test. Statistical significance is set at p ≤ 0.05.

Hypothesis:

An enhanced PAP-support by physiotherapist gives room for enlarged effects on physical activity level with an opportunity to influence cardiorespiratory fitness, metabolic health and health related quality of life.

Clinical implication:

An increased physical activity level in the non-responder group via an individually designed PAP-support by physiotherapist will increase the possibility to save time and resources for both the patients and health care system. Evaluating effects on cardiorespiratory fitness in addition to metabolic health and health related quality of life gives an immersed understanding of the health effects due to this intervention.

Conditions: Health Behavior, Activities of Daily Living, Metabolic Syndrome X, Quality of Life
Being tested: PAP-treatment by physiotherapist, Ordinary PAP-treatment at the health care center
Keywords: Physical Therapy Specialty, Exercise Test, Prescriptions, Counseling, Primary Health Care, Exercise
Medical subject headings: Health Behavior, Metabolic Syndrome, Motor Activity

What participants receive

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

PAP-treatment by physiotherapistBehavioural
Ordinary PAP-treatment at the health care centerBehavioural

Study groups in NCT03012516
Study group	Role	What they receive
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.. Receives: 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. Receives: Behavioral: Ordinary PAP-treatment at the health care center

What is being measured

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

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 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.
Measured: 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.
Measured: 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
Measured: Change between baseline and one year follow-up.

Secondary outcomes (10)

Change in anthropometrics - Body mass index (BMI)
Body weight is measured with light clothing and without shoes to the nearest 0.1 kg using an electric scale (Carl Lidén AFW D300, Jönköping, Sweden). Body height is measured in an upright position without shoes to the nearest 0.5 cm using a scale fixed to the wall (Personmått PEM 136, Hultafors, Sweden) and BMI in kg/m^2 is calculated.
Measured: Change between baseline and one year follow-up.
Change in anthropometrics - Waist circumference (WC)
WC, to the nearest 0.5 cm, is measured in a standing exhaled position, with a measuring-tape (Kirchner Wilhelm, Aspberg, Germany) placed on the patients skin between the lower rib and the iliac crest. The cut-off values of metS components according to The National Cholesterol Education Program (NCEP) classification includes WC > 88 cm for women, >102 cm for men.
Measured: Change between baseline and one year follow-up.
Change in systolic blood pressure (SBP)
SBP is measured in mmHg according to guidelines, after 5 minutes rest, with the patient seated, having a blood pressure sphygmomanometer (Omron HEM-907, Kyoto, Japan) attached to the right upper arm at the level of the heart. The cut-off values of metS components according to The National Cholesterol Education Program (NCEP) classification includes SBP ≥ 130 mmHg
Measured: Change between baseline and one year follow-up.
Change in diastolic blood pressure (DBP)
DBP is measured in mmHg according to guidelines, after 5 minutes rest, with the patient seated, having a blood pressure sphygmomanometer (Omron HEM-907, Kyoto, Japan) attached to the right upper arm at the level of the heart. The cut-off values of metS components according to The National Cholesterol Education Program (NCEP) classification includes DBP ≥ 85 mmHg
Measured: Change between baseline and one year follow-up.
Change in blood samples - Plasma glucose after an overnight fast (FPG).
FPG measured in mmol/l and analyzed according to the European Accreditation system. The cut-off values of metS components according to The National Cholesterol Education Program (NCEP) classification includes FPG ≥ 6.1.
Measured: Change between baseline and one year follow-up.
Change in blood samples - Triglycerides (TG).
TG measured in mmol/l and analyzed according to the European Accreditation system. The cut-off values of metS components according to The National Cholesterol Education Program (NCEP) classification includes TG ≥ 1.7 mmol/l.
Measured: Change between baseline and one year follow-up.
Change in blood samples - Cholesterol.
Cholesterol measured in mmol/l and analyzed according to the European Accreditation system.
Measured: Change between baseline and one year follow-up.
Change in blood samples - High Density Lipoprotein (HDL).
HDL measured in mmol/l and analyzed according to the European Accreditation system.The cut-off values of metS components according to The National Cholesterol Education Program (NCEP) classification includes HDL < 1.3 mmol/l for women, < 1.0 mmol/l for men.
Measured: Change between baseline and one year follow-up.
Change in blood samples - Low Density Lipoprotein (LDL).
LDL measured in mmol/l and analyzed according to the European Accreditation system.
Measured: Change between baseline and one year follow-up.
Change in health related quality of life - Short Form 36 (SF-36)
Assessed with the Swedish version of the Short Form 36 (SF-36 Standard Swedish Version 1.0) which includes 36 questions. It 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: Change between baseline and one year follow-up.

Timeline

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

Jan 201015 Sep 2020

First posted6 Jan 2017 (estimated)
Study startJan 2010
Primary completionJun 2018
Study completion15 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Health BehaviorStudies of the same condition, open and under way.
More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03012516
Sponsor's protocol ID: PAP-study RCT 206261
Status last verified: Dec 2020
First submitted: 30 Dec 2016
Last updated: 16 Dec 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 19136507
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.
PubMed 3920711
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.
PubMed 17762377
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.
PubMed 22058134
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.
PubMed 22451477
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.
PubMed 23199848
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.
PubMed 19237997
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.
PubMed 18627557
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.
PubMed 26193882
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.
PubMed 21078135
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
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.
PubMed 1329589
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.
PubMed 12900694
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.
PubMed 26589125
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.
PubMed 11368702

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care

All Health Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical Activity on Prescription With Two Different Strategies. One Year Follow-up Regarding Physical Activity Level, Metabolic Health and Health-related Quality of Life. A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT03012516
Acronym / sponsor ID: PAP-study RCT 206261
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Vastra Gotaland RegionOther government
Study start: Jan 2010 (actual)
Primary completion: Jun 2018 (actual)
Study completion: 15 Sep 2020 (actual)
First posted: 6 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim:

Methods:

Study design:

This is a randomized controlled trial (RCT) with two arms: one intervention group and one control group. The present study is part of an ongoing study including 444 patients with a 5 years follow-up.

Study population:

Intervention:

Measurements:

Statistical analysis:

Hypothesis:

Clinical implication:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PAP-treatment by physiotherapist.	Experimental	Behavioral: PAP-treatment by physiotherapistEnhanced PAP-support by physiotherapist including fitness test, individualized dialogue concerning PA, prescribed PAP and a 7 times follow-up during the one year intervention..
Ordinary PAP-treatment at the health care centre.	Active comparator	Behavioral: Ordinary PAP-treatment at the health care centerOrdinary PAP-treatment at the health care centre including individualized dialogue concerning PA, prescribed PAP and an individually adjusted follow-up.

Who may qualify

Ages: 27 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

The patient decline to participate.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PAP-treatment by physiotherapist	Behavioural	PAP-treatment by physiotherapist.
Ordinary PAP-treatment at the health care center	Behavioural	Ordinary PAP-treatment at the health care centre.

Primary outcome

Change in self-assessed PA-level according to the public health recommendation.
Time frame: Change between baseline and one year follow-up.
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 in self-assessed PA-level - IPAQ
Time frame: Change between baseline and one year follow-up.
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 in self-assessed PA-level - SGPALS
Time frame: Change between baseline and one year follow-up.
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 in self-assessed PA-level - a six grade PA scale
Time frame: Change between baseline and one year follow-up.
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

10 secondary outcomes

Change in anthropometrics - Body mass index (BMI)
Time frame: Change between baseline and one year follow-up.
Change in anthropometrics - Waist circumference (WC)
Time frame: Change between baseline and one year follow-up.
Change in systolic blood pressure (SBP)
Time frame: Change between baseline and one year follow-up.
Change in diastolic blood pressure (DBP)
Time frame: Change between baseline and one year follow-up.
Change in blood samples - Plasma glucose after an overnight fast (FPG).
Time frame: Change between baseline and one year follow-up.
Change in blood samples - Triglycerides (TG).
Time frame: Change between baseline and one year follow-up.
Change in blood samples - Cholesterol.
Time frame: Change between baseline and one year follow-up.
Change in blood samples - High Density Lipoprotein (HDL).
Time frame: Change between baseline and one year follow-up.
Change in blood samples - Low Density Lipoprotein (LDL).
Time frame: Change between baseline and one year follow-up.
Change in health related quality of life - Short Form 36 (SF-36)
Time frame: Change between baseline and one year follow-up.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Background: PubMed 19136507Blair 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.
Background: PubMed 3920711Caspersen 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.
Background: PubMed 17762377Haskell 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.
Background: PubMed 22058134Pavey 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.
Background: PubMed 22451477Orrow 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.
Background: PubMed 23199848Hallal 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.
Background: PubMed 19237997Kallings 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.
Background: PubMed 18627557Leijon 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.
Background: PubMed 26193882Olsson 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.
Background: PubMed 21078135Persson 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.
Background: PubMed 25459975Sallis 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.
Background: PubMed 1329589Prochaska 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.
Individual participant dataSharing planned: No

Related trials for Health Behavior

Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Åsa Cider, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 Dec 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 one year follow-up.). The study lists 4 primary outcomes in all. 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 NCT03012516, which also lists 19 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 16 Dec 2020.