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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- Gerencia de Atención Primaria, Madrid
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Perceived Health Related Quality of Life
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Pedro Otones Reyes
Principal Investigator. Cinical nurse
Gerencia de Atención Primaria, Madrid
Eligibility Criteria
Inclusion Criteria
- •Clinical record of Chronic Pain by International Classification of Primary Care (ICPC) Code A
- •Being classified as pre-frail by SHARE-FI questionnaire.
- •Informed consent
Exclusion Criteria
- •Housebound patients
- •Institutionalized patients
- •Not living in the area of the investigation
- •Dependence for bADL
- •Not being fluent in Spanish
- •Severe mental illness or cognitive disorder
Outcomes
Primary Outcomes
Perceived Health Related Quality of Life
Time Frame: Change from baseline at 2 and 5 months
Quality of life assessed by EuroQol 5 Dimen (EQ5D-5L) Scale. It consist on a Quality Index (Range 0-1) calculated from scores of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with value for Spain set and a Visual Analog Scale (Range 0: Worst possible health-100: Best possible health).
Secondary Outcomes
- Frailty Status(Change from baseline at 2 and 5 months)
- Physical Performance(Change from baseline at 2 and 5 months)
- Satisfaction with the intervention(At 2 months)
- Pain Intensity(Change from baseline at 2 and 5 months)
- Basic Activities of Daily Living (bADL)(Change from baseline at 2 and 5 months)
- Depression(Change from baseline at 2 and 5 months)
- Number of meetings attended(At 2 months)
- Falls(At 2 months and at 5 months)