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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intervention with nurse and patients |
|
| Usual care | Active Comparator | Usual clinical care based on current clinical practice guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Program | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Otones Reyes, RN, PhDc | Gerencia de Atención Primaria, Madrid | Principal Investigator |
| Eva GarcÃa Perea, RN, PhD | Universidad Autonoma de Madrid | Study Director |
| Azucena Pedraz Marcos, RN, PhD | Universidad Autonoma de Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerencia de Atención Primaria, Madrid | Madrid | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33032532 | Derived | Otones P, Garcia E, Sanz T, Pedraz A. A physical activity program versus usual care in the management of quality of life for pre-frail older adults with chronic pain: randomized controlled trial. BMC Geriatr. 2020 Oct 8;20(1):396. doi: 10.1186/s12877-020-01805-3. |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
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| Usual care | Other | Usual clinical care based on current clinical practice guidelines. |
|
| 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 |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |