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

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Frailty; Old Age; Debility
• Intervention / Treatment: Other: Physical Activity Program; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Comunidad De Madrid
    • Madrid, Comunidad De Madrid, Spain
      • Gerencia de Atención Primaria, Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention with nurse and patients	Other: 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.; Other: Usual care; Usual clinical care based on current clinical practice guidelines.
Active Comparator: Usual care; Usual clinical care based on current clinical practice guidelines.	Other: Usual care; Usual clinical care based on current clinical practice guidelines.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Investigators: Principal Investigator: Pedro Otones Reyes, RN, PhDc, Gerencia de Atención Primaria, Madrid; Study Director: Eva García Perea, RN, PhD, Universidad Autónoma de Madrid; Study Director: Azucena Pedraz Marcos, RN, PhD, Universidad Autónoma de Madrid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): July 2, 2019

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 4, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Primary Health Care; Nursing Intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Chronic Pain; Frailty
• Other Study ID Numbers: CT180719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No