Physical Activity on Prescription in Patients With Metabolic Risk Factors.
Condition: Health Behavior; Activities of Daily Living; Metabolic Syndrome X; Quality of Life
MeSH terms: Metabolic Syndrome
Study type: Interventional

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.
    

Intervention name(s): PAP-treatment by physiotherapist; Ordinary PAP-treatment at the health care center
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Therapy Specialty; Exercise Test; Prescriptions; Counseling; Primary Health Care; Exercise