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

Study Overview
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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.

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.

Official Title
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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.

Conditions
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Frailty, Chronic Pain, Old Age; Debility

Intervention / Treatment
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* Other: Physical Activity Program
* Other: Usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention with nurse and patients | Other: Physical Activity Program<br>* 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.<br>Other: Usual care<br>* Usual clinical care based on current clinical practice guidelines.<br>|
| Active Comparator: Usual care<br>Usual clinical care based on current clinical practice guidelines. | Other: Usual care<br>* Usual clinical care based on current clinical practice guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Health Related Quality of Life | 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). | Change from baseline at 2 and 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain Intensity was assessed by McGill Pain Questionnaire's Visual Analog Scale (VAS). It consists on a 100mm horizontal line in which patient points the intensity of his pain. It is measured from left to right. Left side of the line (0 millimeters, mm) means no pain and it is the minimum score and right side of the line (100mm) means pain as worst as you can imagine and it is maximum score. Lower punctuation meana better outcomes. | Change from baseline at 2 and 5 months | 
| Frailty Status | Frailty Status assessed by SHARE-FI (Survey of Health, Ageing and Retirement Frailty Index). It consists on summarizing the response to 5 criteria (exhaustion, weight loss, weakness, slowness and low active) in a discreet factor (DFS). Scores are different for men and women. Women: If predicted DFS < 0.31, NON-FRAIL; If predicted DFS < 2.13, PRE-FRAIL; If predicted DFS < 6, FRAIL Men: If predicted DFS < 1.21, NON-FRAIL; If predicted DFS < 3.00, PRE-FRAIL; If predicted DFS < 7, FRAIL | Change from baseline at 2 and 5 months | 
| Physical Performance | Assessed by Short Physical Performance Battery (SPPB). It evaluates balance, walk speed and sitting and standing in a chair. Each Item is scored 0-4 points. Yielding a total between 0 (worst physical performance ) and 12 (best physical performance). | Change from baseline at 2 and 5 months | 
| Falls | Number of falls during the follow-up process | At 2 months and at 5 months | 
| Depression | Assessed by ultra-short Yesavage Scale (Geriatric Depression Scale, GDS-5). It consist on 5 questions of the GDS-15 questionnaire (Range:0-5. Cutpoint for depression: 2). | Change from baseline at 2 and 5 months | 
| Basic Activities of Daily Living (bADL) | Assessed by Barthel Scale. It assesses the help needed with ten variables: feeding, bathing, grooming, dressing, urinary incontinence, faecal incontinence, toilet use, transfers bed to chair, mobility and climbing stairs. (Range: 0: Full Dependence - 100: Independence for bADL). | Change from baseline at 2 and 5 months | 
| Number of meetings attended | Number of meetings attended by the participants from intervention group. | At 2 months | 
| Satisfaction with the intervention | Assessed with Client Satisfaction Questionnaire (CSQ-8). It consist on 8 questions (four ranged 4: most satisfaction-1: least satisfaction and four ranged 1: most satisfaction -4 least satisfaction) | At 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Health Care, Nursing Intervention, Physical Activity