NCT04490395

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

Completed NA Results posted Last updated 5 January 2023

What this trial tests

NA trial testing Engage PA in Osteoarthritis, Knee in 40 participants. Completed in 6 October 2021.

Timeline

5 January 2021

Primary endpoint
6 October 2021

6 October 2021

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	5 January 2021
Primary completion	6 October 2021
Estimated completion	6 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Engage PA
• Treatment as Usual plus (TAU+)

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
• Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →

Sponsor

Duke University

Who can join

65 and older, any sex, with Osteoarthritis, Knee or Osteoarthritis, Hip. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Enrolled in the Study Primary · 9 months

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

Group	Value	95% CI
Engage PA	19
Treatment as Usual Plus Fitness Tracker	20

Number of Participants Who Completed the Entire Program Primary · 6 weeks

Participants who complete all assessments and required study sessions

Group	Value	95% CI
Engage PA	19
Treatment as Usual Plus Fitness Tracker	20

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

Group	Value	95% CI
Engage PA	89

Arthritis Pain (AIMS 2 Symptom Subscale) Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	13.72	± 3.80
Treatment as Usual Plus Fitness Tracker	14.90	± 4.16

Post-Treatment

Group	Value	95% CI
Engage PA	11.78	± 3.69
Treatment as Usual Plus Fitness Tracker	14.58	± 4.50

Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	6.38	± 1.89
Treatment as Usual Plus Fitness Tracker	7.44	± 2.00

Post-Treatment

Group	Value	95% CI
Engage PA	6.64	± 1.38
Treatment as Usual Plus Fitness Tracker	7.51	± 2.09

Psychological Distress (AIMS 2 Affect Subscale) Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	10.36	± 3.12
Treatment as Usual Plus Fitness Tracker	10.37	± 2.85

Post-treatment

Group	Value	95% CI
Engage PA	10.59	± 4.15
Treatment as Usual Plus Fitness Tracker	10.33	± 2.18

Daily Step Count in 7 Day Period Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	35712.55	± 27441.78
Treatment as Usual Plus Fitness Tracker	28165.89	± 20916.05

Post-treatment

Group	Value	95% CI
Engage PA	38268.56	± 28154.68
Treatment as Usual Plus Fitness Tracker	28154.67	± 29183.00

Rapid Assessment of Physical Activity Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	3.25	± 1.22
Treatment as Usual Plus Fitness Tracker	3.16	± 1.50

Post-treatment

Group	Value	95% CI
Engage PA	3.47	± 1.73
Treatment as Usual Plus Fitness Tracker	2.31	± 1.19

Psychological Flexibility Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	13.95	± 8.20
Treatment as Usual Plus Fitness Tracker	16.21	± 7.45

Post-Treatment

Group	Value	95% CI
Engage PA	14.72	± 8.37
Treatment as Usual Plus Fitness Tracker	13.05	± 6.31

Valued Living - Health Domain Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	4.11	± 2.26
Treatment as Usual Plus Fitness Tracker	4.05	± 1.99

Post-treatment

Group	Value	95% CI
Engage PA	3.76	± 1.44
Treatment as Usual Plus Fitness Tracker	4.88	± 1.73

Valued Living - Leisure Domain Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	4.26	± 2.26
Treatment as Usual Plus Fitness Tracker	4.60	± 4.18

Post-treatment

Group	Value	95% CI
Engage PA	4.12	± 1.87
Treatment as Usual Plus Fitness Tracker	4.18	± 2.01

Valued Living - Relationship Domain Secondary · 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.

Baseline

Group	Value	95% CI
Engage PA	3.68	± 2.11
Treatment as Usual Plus Fitness Tracker	4.29	± 2.29

Post-treatment

Group	Value	95% CI
Engage PA	4.00	± 2.10
Treatment as Usual Plus Fitness Tracker	4.35	± 2.15

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain.
   Plumb Vilardaga JC, Kelleher SA, Diachina A, Riley J, et al · · 2022 · cited 7× · PMID 35915512 · DOI 10.1186/s40814-022-01121-0
2. Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain
   Vilardaga JCP, Kelleher S, Diachina A, Riley J, et al · · 2022 · DOI 10.21203/rs.3.rs-1182374/v1