Physical Activity on Prescription in Patients With Metabolic Risk Factors.

December 13, 2020 updated by: Vastra Gotaland Region

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • The patient decline to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAP-treatment by physiotherapist.
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
Active Comparator: Ordinary PAP-treatment at the health care centre.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 between baseline and one year follow-up.
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 between baseline and one year follow-up.
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 between baseline and one year follow-up.
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
Change between baseline and one year follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anthropometrics - Body mass index (BMI)
Time Frame: Change between baseline and one year follow-up.
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.
Change between baseline and one year follow-up.
Change in anthropometrics - Waist circumference (WC)
Time Frame: Change between baseline and one year follow-up.
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.
Change between baseline and one year follow-up.
Change in systolic blood pressure (SBP)
Time Frame: Change between baseline and one year follow-up.
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
Change between baseline and one year follow-up.
Change in diastolic blood pressure (DBP)
Time Frame: Change between baseline and one year follow-up.
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
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.
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.
Change between baseline and one year follow-up.
Change in blood samples - Triglycerides (TG).
Time Frame: Change between baseline and one year follow-up.
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.
Change between baseline and one year follow-up.
Change in blood samples - Cholesterol.
Time Frame: Change between baseline and one year follow-up.
Cholesterol measured in mmol/l and analyzed according to the European Accreditation system.
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.
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.
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.
LDL measured in mmol/l and analyzed according to the European Accreditation system.
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.
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.
Change between baseline and one year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Åsa Cider, PhD, Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, , Gothenburg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 15, 2020

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 13, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAP-study RCT 206261

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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