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

NCT04490395 | Completed Results

• 1 other identifier: Pro00105573
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Engage PA; treatment as usual

Outcome Measures

Primary Outcomes (3)

• 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

• Number of Participants Who Completed the Entire Program

  Participants who complete all assessments and required study sessions

  6 weeks

• 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 Outcomes (10)

• Arthritis Pain (AIMS 2 Symptom Subscale)

  Baseline, post-treatment (6 weeks)

• Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)

  Baseline, post-treatment (6 weeks)

• Psychological Distress (AIMS 2 Affect 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)

Study Arms (2)

Engage PA

EXPERIMENTAL

Behavioral: Engage PA

Treatment as usual plus fitness tracker

OTHER

Other: Treatment as Usual plus (TAU+)

Interventions

Engage PA BEHAVIORAL

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.

Engage PA

Treatment as Usual plus (TAU+) OTHER

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.

Treatment as usual plus fitness tracker

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Plumb Vilardaga JC, Kelleher SA, Diachina A, Riley J, Somers TJ. Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain. Pilot Feasibility Stud. 2022 Aug 1;8(1):164. doi: 10.1186/s40814-022-01121-0.

  PMID: 35915512 DERIVED

• Vilardaga JCP, Kelleher S, Diachina A, Riley J, Somers T. Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain. Res Sq [Preprint]. 2022 Jan 3:rs.3.rs-1182374. doi: 10.21203/rs.3.rs-1182374/v1.

  PMID: 35018370 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Changes to measurement type during trial due to pandemic-related challenges (no objective daily steps data available despite intention to collect this data).

Results Point of Contact

• Title: Jennifer Plumb Vilardaga, PhD
• Organization: Duke University

jennifer.plumb.vilardaga@duke.edu

919-668-6123

Study Officials

• Jennifer Plumb Vilardaga, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: January 5, 2021
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)