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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Perceived Health Related Quality of Life
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
Intervention with nurse and patients
Intervention: Physical Activity Program (Other)
Intervention group
Intervention with nurse and patients
Intervention: Usual care (Other)
Usual care
Usual clinical care based on current clinical practice guidelines.
Intervention: Usual care (Other)
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)
Investigators
Pedro Otones Reyes
Principal Investigator. Cinical nurse
Gerencia de Atención Primaria, Madrid