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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490395
• Other study ID #: Pro00105573
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: October 6, 2021

Study information

• Verified date: December 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Behavioral:
• Engage PA
Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.

Other:
• Treatment as Usual plus (TAU+)
The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Enrolled in the Study	How many participants, up to the expected 40 participants, enroll in the study within the study period	9 months
Primary	Number of Participants Who Completed the Entire Program	Participants who complete all assessments and required study sessions	6 weeks
Primary	Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention	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.	Post treatment (6 weeks)
Secondary	Arthritis Pain (AIMS 2 Symptom Subscale)	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.	Baseline, post-treatment (6 weeks)
Secondary	Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)	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.	Baseline, post-treatment (6 weeks)
Secondary	Psychological Distress (AIMS 2 Affect Subscale)	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.	Baseline, post-treatment (6 weeks)
Secondary	Daily Step Count in 7 Day Period	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.	Baseline, post-treatment (6 weeks)
Secondary	Rapid Assessment of Physical Activity	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.	Baseline, post-treatment (6 weeks)
Secondary	Psychological Flexibility	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.	Baseline, post-treatment (6 weeks)
Secondary	Valued Living - Health Domain	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.	Baseline, post-treatment (6 weeks)
Secondary	Valued Living - Leisure Domain	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.	Baseline, post-treatment (6 weeks)
Secondary	Valued Living - Relationship Domain	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.	Baseline, post-treatment (6 weeks)
Secondary	Valued-Living - Work/Community Domain	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.	Baseline, post-treatment (6 weeks)