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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2019-07-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Frailty Chronic Pain Old Age; Debility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.

Study Groups

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Intervention group

Intervention with nurse and patients

Group Type EXPERIMENTAL

Physical Activity Program

Intervention Type OTHER

Usual Care and a nurse-led physical activity program once a week for 8 weeks. Each session last for 60 minutes, 15 for warming-up and 45 for different exercises.

Usual care

Intervention Type OTHER

Usual clinical care based on current clinical practice guidelines.

Usual care

Usual clinical care based on current clinical practice guidelines.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual clinical care based on current clinical practice guidelines.

Interventions

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Physical Activity Program

Usual Care and a nurse-led physical activity program once a week for 8 weeks. Each session last for 60 minutes, 15 for warming-up and 45 for different exercises.

Intervention Type OTHER

Usual care

Usual clinical care based on current clinical practice guidelines.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No