Effectiveness of a Physical Activity Intervention for Pre-frail Older Adults With Chronic Pain.
- Conditions
- Chronic PainFrailtyOld Age; Debility
- Interventions
- Other: Usual careOther: Physical Activity Program
- Registration Number
- NCT04045535
- Lead Sponsor
- Gerencia de Atención Primaria, Madrid
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care Usual clinical care based on current clinical practice guidelines. Intervention group Physical Activity Program Intervention with nurse and patients Intervention group Usual care Intervention with nurse and patients
- Primary Outcome Measures
Name Time Method Perceived Health Related Quality of Life 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 Outcome Measures
Name Time Method Frailty Status Change from baseline at 2 and 5 months 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, FRAILPhysical Performance Change from baseline at 2 and 5 months 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).
Satisfaction with the intervention At 2 months 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)
Pain Intensity Change from baseline at 2 and 5 months 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.
Basic Activities of Daily Living (bADL) Change from baseline at 2 and 5 months 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).
Depression Change from baseline at 2 and 5 months 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).
Number of meetings attended At 2 months Number of meetings attended by the participants from intervention group.
Falls At 2 months and at 5 months Number of falls during the follow-up process
Trial Locations
- Locations (1)
Gerencia de Atención Primaria, Madrid
🇪🇸Madrid, Comunidad De Madrid, Spain