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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.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
Gerencia de Atención Primaria, Madrid
Madrid, Madrid, Spain
Start Date
June 6, 2018
Primary Completion Date
July 2, 2019
Completion Date
July 2, 2019
Last Updated
August 7, 2019
44
ACTUAL participants
Physical Activity Program
OTHER
Usual care
OTHER
Lead Sponsor
Gerencia de Atención Primaria, Madrid
NCT07469761
NCT04379115
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT06587607