Physical Activity on Prescription in Patients With Metabolic Risk Factors.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03012516
• Date of registration: 30/12/2016
• Prospective Registration: No
• Primary sponsor: Vastra Gotaland Region
• Public title: Physical Activity on Prescription in Patients With Metabolic Risk Factors.
• Scientific 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.
• Date of first enrolment: January 2010
• Target sample size: 190
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03012516
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

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

Key inclusion & exclusion 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.



Age minimum: 27 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Quality of Life

Metabolic Syndrome X

Health Behavior

Activities of Daily Living

Intervention(s)

Behavioral: PAP-treatment by physiotherapist

Behavioral: Ordinary PAP-treatment at the health care center

Primary Outcome(s)

Change in self-assessed PA-level - SGPALS [Time Frame: 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.]

Change in self-assessed PA-level according to the public health recommendation. [Time Frame: 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.]

Secondary Outcome(s)

Change in blood samples - High Density Lipoprotein (HDL). [Time Frame: Change between baseline and one year follow-up.]

Change in anthropometrics - Body mass index (BMI) [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 - 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 anthropometrics - Waist circumference (WC) [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 diastolic blood pressure (DBP) [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.]

Change in systolic blood pressure (SBP) [Time Frame: Change between baseline and one year follow-up.]

Secondary ID(s)

PAP-study RCT 206261

Source(s) of Monetary Support

Please refer to primary and secondary sponsors