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Clinical Trials/NCT04490395
NCT04490395
Completed
N/A

Increasing Physical Resilience in Older Adults With Osteoarthritis Pain: Feasibility and Acceptability of a Brief Behavioral Physical Activity Intervention

Duke University1 site in 1 country40 target enrollmentJanuary 5, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Duke University
Enrollment
40
Locations
1
Primary Endpoint
Number of Participants Enrolled in the Study
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2021
End Date
October 6, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of Participants Enrolled in the Study

Time Frame: 9 months

How many participants, up to the expected 40 participants, enroll in the study within the study period

Number of Participants Who Completed the Entire Program

Time Frame: 6 weeks

Participants who complete all assessments and required study sessions

Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention

Time Frame: Post treatment (6 weeks)

Client Satisfaction Questionnaire asks 12 questions related to patient satisfaction on a Likert scale of 1 = very satisfied to 7 = very dissatisfied. There is one item assessing overall satisfaction with the intervention, and the percentage of participants responding to this item with "mostly" or "very" satisfied is reported below.

Secondary Outcomes

  • Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)(Baseline, post-treatment (6 weeks))
  • Daily Step Count in 7 Day Period(Baseline, post-treatment (6 weeks))
  • Rapid Assessment of Physical Activity(Baseline, post-treatment (6 weeks))
  • Valued Living - Health Domain(Baseline, post-treatment (6 weeks))
  • Valued Living - Leisure Domain(Baseline, post-treatment (6 weeks))
  • Arthritis Pain (AIMS 2 Symptom Subscale)(Baseline, post-treatment (6 weeks))
  • Psychological Distress (AIMS 2 Affect Subscale)(Baseline, post-treatment (6 weeks))
  • Psychological Flexibility(Baseline, post-treatment (6 weeks))
  • Valued Living - Relationship Domain(Baseline, post-treatment (6 weeks))
  • Valued-Living - Work/Community Domain(Baseline, post-treatment (6 weeks))

Study Sites (1)

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