Clinical trial NCT04490395: Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention
Official title: Increasing Physical Resilience in Older Adults With Osteoarthritis Pain: Feasibility and Acceptability of a Brief Behavioral Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Engage PA
treatment as usual
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-07-29
Enrollment: 40
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 study is to evaluate how older adults might benefit from sessions that teach behavioral coping skills for increasing physical activity and reducing interference from arthritis pain. This study will randomize individuals to receive Engage-PA, or continue to receive treatment as usual. Engage-PA involves two sessions (about 45 minutes each) with a study therapist that teaches individuals behavioral skills for increasing daily steps. These behavioral skills include identifying their personal values and instructions on how to pace their daily physical activity to avoid creating severe pain when walking. All participants in the study will wear small devices that track physical activity such as daily steps throughout the study, which also allow participants to see their daily step counts and overall level of activity. All participants will answer a set of questions about how much arthritis gets the way of many important life activities, their success at living in line with their personal values, and how much thoughts, feelings and body sensations get in the way of living a satisfying life. These questions will be asked at the beginning of the study and 6 weeks into the study.


Eligibility criteria: Inclusion Criteria:

* Age 65 or older
* English speaking
* Diagnosis of osteoarthritis in knee or hip
* Able to ambulate even if assisted with ambulatory device such as walker or cane
* Endorse worst pain and pain interference as ≥ 3 out of 10 within the last week

Exclusion Criteria:

* Planned surgery during study duration that would limit mobility (e.g., due to recommended rehabilitation or recovery period) for more than 3 weeks
* Current enrollment in cardiac rehabilitation
* Myocardial infarction in the past 3 months
* Major surgery requiring limited movement or mobility for recovery within the past 3 months
* Presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating medical provider or other staff, or study staff interactions that would contraindicate safe study participation
* Medical provider indicating that exercise (even walking) should only be medically supervised; as determined by medical record review or patient reported
* Fall or falls within the last 3 months that led to immediate medical treatment/hospitalization
* Reported or suspected moderate or severe cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of \<19

Primary outcomes:
measure: Number of Participants Enrolled in the Study
timeFrame: 9 months
measure: Number of Participants Who Completed the Entire Program
timeFrame: 6 weeks
measure: Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention
timeFrame: Post treatment (6 weeks)
Secondary outcomes:
measure: Arthritis Pain (AIMS 2 Symptom Subscale)
timeFrame: Baseline, post-treatment (6 weeks)
measure: Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)
timeFrame: Baseline, post-treatment (6 weeks)
measure: Psychological Distress (AIMS 2 Affect Subscale)
timeFrame: Baseline, post-treatment (6 weeks)
measure: Daily Step Count in 7 Day Period
timeFrame: Baseline, post-treatment (6 weeks)
measure: Rapid Assessment of Physical Activity
timeFrame: Baseline, post-treatment (6 weeks)
measure: Psychological Flexibility
timeFrame: Baseline, post-treatment (6 weeks)
measure: Valued Living - Health Domain
timeFrame: Baseline, post-treatment (6 weeks)
measure: Valued Living - Leisure Domain
timeFrame: Baseline, post-treatment (6 weeks)
measure: Valued Living - Relationship Domain
timeFrame: Baseline, post-treatment (6 weeks)
measure: Valued-Living - Work/Community Domain
timeFrame: Baseline, post-treatment (6 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Jennifer Plumb Vilardaga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plumb Vilardaga JC, Kelleher SA, Diachina A, Riley J, Somers TJ. Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain. Pilot Feasibility Stud. 2022 Aug 1;8(1):164. doi: 10.1186/s40814-022-01121-0.
citation: Vilardaga JCP, Kelleher S, Diachina A, Riley J, Somers T. Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain. Res Sq [Preprint]. 2022 Jan 3:rs.3.rs-1182374. doi: 10.21203/rs.3.rs-1182374/v1.