Effectiveness of a Physical Activity Intervention for Pre-frail Older Adults With Chronic Pain.

Gerencia de Atención Primaria, Madrid

Status: Completed

Conditions: Chronic Pain; Frailty; Old Age; Debility

Treatments: Other: Usual care; Other: Physical Activity Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04045535

CT180719

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical record of Chronic Pain by International Classification of Primary Care (ICPC) Code A01.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intervention with nurse and patients

Treatment:

Other: Usual care

Other: Physical Activity Program

Usual care

Active Comparator group

Description:

Usual clinical care based on current clinical practice guidelines.

Treatment:

Other: Usual care