Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Interventions: Other: Treatment as Usual plus (TAU+); Behavioral: Engage PA

• Registration Number: NCT04490395
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-29
• Study Start: 2021-01-05
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-06
• Results First Submitted: 2022-10-05
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Results First Posted: 2023-01-05
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual plus fitness tracker	Treatment as Usual plus (TAU+)	-
Engage PA	Engage PA	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Enrolled in the Study	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	6 weeks	Participants who complete all assessments and required study sessions
Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention	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 Outcome Measures

Name	Time	Method
Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)	Baseline, post-treatment (6 weeks)	The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Physical functioning subscale includes items assessing mobility level, walking and bending, self-care and household tasks. Range is 5-25 where higher scores indicate worse functioning.
Daily Step Count in 7 Day Period	Baseline, post-treatment (6 weeks)	Daily step counts as reported to study staff, after participants recorded them from wearable fitness trackers at end of day. Each assessment period consisted of 7 continuous days of wear. Summed totals of steps in the 7 day period were calculated, and then means calculated between groups of these summed step counts for the 7 day assessment period.
Rapid Assessment of Physical Activity	Baseline, post-treatment (6 weeks)	The RAPA is a self-reported measure that assesses participants engagement in a variety of activities, such as light movement, moderate activity, vigorous activity, and other activities such as strength-training or yoga. Scores range from 0 - 7, where higher scores indicate greater involvement in physical activity overall.
Valued Living - Health Domain	Baseline, post-treatment (6 weeks)	The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.
Valued Living - Leisure Domain	Baseline, post-treatment (6 weeks)	The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.
Arthritis Pain (AIMS 2 Symptom Subscale)	Baseline, post-treatment (6 weeks)	The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living both with a total score and on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Symptom subscale includes items assessing pain severity, stiffness, and physical discomfort. Range is 5 to 25 where higher scores indicate worse functioning.
Psychological Distress (AIMS 2 Affect Subscale)	Baseline, post-treatment (6 weeks)	The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Psychological distress subscale includes items assessing mood and anxiety/tension. Range is 5-25 where higher scores indicate worse functioning.
Psychological Flexibility	Baseline, post-treatment (6 weeks)	The Acceptance and Action Questionnaire-II asks about psychological flexibility, defined as how often thoughts, feelings and body sensations get in the way of living a fulfilling life. Responses are on a 1 to 7 Likert scale with 1 indicating that these issues never get in the way, and 7 indicating that these issues always get in the way. Range is 7 - 49, with lower scores indicating better outcomes.
Valued Living - Relationship Domain	Baseline, post-treatment (6 weeks)	The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful.
Valued-Living - Work/Community Domain	Baseline, post-treatment (6 weeks)	The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States