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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Engage PA

Treatment as Usual plus (TAU+)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Engage PA, treatment as usual

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Engage PA

Treatment as usual plus fitness tracker

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Enrolled in the Study

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

Participants who complete all assessments and required study sessions

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04490395

First Posted

July 24, 2020

Last Updated

December 12, 2022

Sponsor

Duke University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04490395

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 5, 2021 (Actual)

Primary Completion Date

October 6, 2021 (Actual)

Study Completion Date

October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Osteoarthritis, Hip

Keywords

Engage PA, treatment as usual

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Engage PA

Arm Type

Experimental

Arm Title

Treatment as usual plus fitness tracker

Arm Type

Other

Intervention Type

Behavioral

Intervention Name(s)

Engage PA

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Treatment as Usual plus (TAU+)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants Enrolled in the Study

Description

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

Time Frame

9 months

Title

Number of Participants Who Completed the Entire Program

Description

Participants who complete all assessments and required study sessions

Time Frame

6 weeks

Title

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

Description

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.

Time Frame

Post treatment (6 weeks)

Secondary Outcome Measure Information:

Title

Arthritis Pain (AIMS 2 Symptom Subscale)

Description

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.

Time Frame