Clinical trial NCT03012516: Physical Activity on Prescription in Patients With Metabolic Risk Factors.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2017-01-06
Enrollment: 190
Sex: ALL
Minimum age (years): 27
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in self-assessed PA-level according to the public health recommendation.
timeFrame: Change between baseline and one year follow-up.
measure: Change in self-assessed PA-level - IPAQ
timeFrame: Change between baseline and one year follow-up.
measure: Change in self-assessed PA-level - SGPALS
timeFrame: Change between baseline and one year follow-up.
measure: Change in self-assessed PA-level - a six grade PA scale
timeFrame: Change between baseline and one year follow-up.
Secondary outcomes:
measure: Change in anthropometrics - Body mass index (BMI)
timeFrame: Change between baseline and one year follow-up.
measure: Change in anthropometrics - Waist circumference (WC)
timeFrame: Change between baseline and one year follow-up.
measure: Change in systolic blood pressure (SBP)
timeFrame: Change between baseline and one year follow-up.
measure: Change in diastolic blood pressure (DBP)
timeFrame: Change between baseline and one year follow-up.
measure: Change in blood samples - Plasma glucose after an overnight fast (FPG).
timeFrame: Change between baseline and one year follow-up.
measure: Change in blood samples - Triglycerides (TG).
timeFrame: Change between baseline and one year follow-up.
measure: Change in blood samples - Cholesterol.
timeFrame: Change between baseline and one year follow-up.
measure: Change in blood samples - High Density Lipoprotein (HDL).
timeFrame: Change between baseline and one year follow-up.
measure: Change in blood samples - Low Density Lipoprotein (LDL).
timeFrame: Change between baseline and one year follow-up.
measure: Change in health related quality of life - Short Form 36 (SF-36)
timeFrame: Change between baseline and one year follow-up.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Närhälsan FaR-teamet centrala och västra Göteborg
state: Region Västra Götaland
Study officials:
affiliation: Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, , Gothenburg, Sweden
name: Åsa Cider, PhD
role: PRINCIPAL_INVESTIGATOR
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