Physical Activity on Prescription in Patients With Metabolic Risk Factors.

Study Overview
=================
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.

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.

Conditions
-----------------
Health Behavior, Activities of Daily Living, Metabolic Syndrome X, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: PAP-treatment by physiotherapist
* Behavioral: Ordinary PAP-treatment at the health care center


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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. | 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Therapy Specialty, Exercise Test, Prescriptions, Counseling, Primary Health Care, Exercise