Effectiveness of a Physical Activity Intervention for Pre-frail Older Adults With Chronic Pain.
Primary Purpose
Frailty, Chronic Pain, Old Age; Debility
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Activity Program
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring Primary Health Care, Nursing Intervention, Physical Activity
Eligibility Criteria
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
Sites / Locations
- Gerencia de Atención Primaria, Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Usual care
Arm Description
Intervention with nurse and patients
Usual clinical care based on current clinical practice guidelines.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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
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).
Falls
Number of falls during the follow-up process
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).
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).
Number of meetings attended
Number of meetings attended by the participants from intervention group.
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)
Full Information
NCT ID
NCT04045535
First Posted
July 30, 2019
Last Updated
August 4, 2019
Sponsor
Gerencia de Atención Primaria, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04045535
Brief Title
Effectiveness of a Physical Activity Intervention for Pre-frail Older Adults With Chronic Pain.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gerencia de Atención Primaria, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Chronic Pain, Old Age; Debility
Keywords
Primary Health Care, Nursing Intervention, Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention with nurse and patients
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual clinical care based on current clinical practice guidelines.
Intervention Type
Other
Intervention Name(s)
Physical Activity Program
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Usual clinical care based on current clinical practice guidelines.
Primary Outcome Measure Information:
Title
Perceived Health Related Quality of Life
Description
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).
Time Frame
Change from baseline at 2 and 5 months
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
Change from baseline at 2 and 5 months
Title
Frailty Status
Description
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
Time Frame
Change from baseline at 2 and 5 months
Title
Physical Performance
Description
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).
Time Frame
Change from baseline at 2 and 5 months
Title
Falls
Description
Number of falls during the follow-up process
Time Frame
At 2 months and at 5 months
Title
Depression
Description
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).
Time Frame
Change from baseline at 2 and 5 months
Title
Basic Activities of Daily Living (bADL)
Description
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).
Time Frame
Change from baseline at 2 and 5 months
Title
Number of meetings attended
Description
Number of meetings attended by the participants from intervention group.
Time Frame
At 2 months
Title
Satisfaction with the intervention
Description
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)
Time Frame
At 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Otones Reyes, RN, PhDc
Organizational Affiliation
Gerencia de Atención Primaria, Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva García Perea, RN, PhD
Organizational Affiliation
Universidad Autonoma de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Azucena Pedraz Marcos, RN, PhD
Organizational Affiliation
Universidad Autonoma de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Gerencia de Atención Primaria, Madrid
City
Madrid
State/Province
Comunidad De Madrid
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33032532
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of a Physical Activity Intervention for Pre-frail Older Adults With Chronic Pain.
We'll reach out to this number within 24 hrs