Clinical trial NCT04045535: 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
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Chronic Pain
Old Age; Debility
Keywords: Primary Health Care
Nursing Intervention
Physical Activity
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
First posted: 2019-08-05
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perceived Health Related Quality of Life
timeFrame: Change from baseline at 2 and 5 months
Secondary outcomes:
measure: Pain Intensity
timeFrame: Change from baseline at 2 and 5 months
measure: Frailty Status
timeFrame: Change from baseline at 2 and 5 months
measure: Physical Performance
timeFrame: Change from baseline at 2 and 5 months
measure: Falls
timeFrame: At 2 months and at 5 months
measure: Depression
timeFrame: Change from baseline at 2 and 5 months
measure: Basic Activities of Daily Living (bADL)
timeFrame: Change from baseline at 2 and 5 months
measure: Number of meetings attended
timeFrame: At 2 months
measure: Satisfaction with the intervention
timeFrame: At 2 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria, Madrid
state: Comunidad De Madrid
Study officials:
affiliation: Gerencia de Atención Primaria, Madrid
name: Pedro Otones Reyes, RN, PhDc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma de Madrid
name: Eva García Perea, RN, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Autonoma de Madrid
name: Azucena Pedraz Marcos, RN, PhD
role: STUDY_DIRECTOR
References:
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.