Chronic Pain Clinical Trial
Official title:
Effectiveness of a Physical Activity Intervention in the Quality of Life of Pre-frail Older Adults Aged 65 Years or Over With Chronic Pain. Randomized Controlled, Multicenter and Pragmatic Trial in Primary Care.
The purpose of this investigation is to evaluate the effectiveness of a multicomponent structured physical exercise program for adults aged 65 years or more, classified as pre-frail and with chronic pain to improve the Perceived Health Related Quality of Life, compared with usual care.
Design: Randomized controlled, pragmatic clinical trial with two groups and 3 months
follow-up.
Unit of randomization: Patient. Unit of analysis: Patient. Setting: A Primary Health Care
Center in the Spanish Autonomous Community of Madrid.
Population: Pre-frail patients aged 65 years or more with chronic pain. Intervention:
Multicomponent structured physical exercise program. Control group: Usual care. Variables:
Perceived Health Related Quality of Life (EuroQol 5D-5L), Pain Intensity (Visual Analogue
Scale), Frailty (SHARE-Frailty Index), Physical Performance (Short Physical Performance
Battery, SPPB), Depression (Yesavage).
Analysis: Mean change differences after 3 months in EQ5D dimensions between groups with CI
95%. Mean differences or proportion differences will be calculated according to variable
characteristics between groups with appropriate statistical test.
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