Osteoarthritis, KneeNCT04490395
Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention
A study testing Engage PA and Treatment as Usual plus (TAU+) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Engage PA and Treatment as Usual plus (TAU+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 6 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Physical Resilience in Older Adults With Osteoarthritis Pain: Feasibility and Acceptability of a Brief Behavioral Physical Activity Intervention
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
- Being tested
- Engage PA, Treatment as Usual plus (TAU+)
- Keywords
- Engage PA, treatment as usual
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engage PABehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Engage PA | Experimental | Not described Receives: Behavioral: Engage PA |
| Treatment as usual plus fitness tracker | Other | Not described Receives: Other: Treatment as Usual plus (TAU+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled in the Study
How many participants, up to the expected 40 participants, enroll in the study within the study period
Measured: 9 months
Number of Participants Who Completed the Entire Program
Participants who complete all assessments and required study sessions
Measured: 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.
Measured: Post treatment (6 weeks)
Secondary outcomes (10)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
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.
Measured: Baseline, post-treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start5 Jan 2021
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jennifer Plumb Vilardaga, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490395
- Sponsor's protocol ID
- Pro00105573
- Status last verified
- Dec 2022
- First submitted
- 24 Jul 2020
- Last updated
- 5 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35915512Vilardaga 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.
PubMed 35018370
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Resilience in Older Adults With Osteoarthritis Pain: Feasibility and Acceptability of a Brief Behavioral Physical Activity Intervention
- ClinicalTrials.gov ID
- NCT04490395
- Acronym / sponsor ID
- Pro00105573
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Engage PA, treatment as usual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Posted 5 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engage PA | Experimental | Behavioral: Engage PA |
| Treatment as usual plus fitness tracker | Other | Other: Treatment as Usual plus (TAU+) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engage PAEngage 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. | Behavioural | Engage PA |
| 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. | Other | Treatment as usual plus fitness tracker |
Primary outcome
Number of Participants Enrolled in the Study
Time frame: 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
Time frame: 6 weeks
Participants who complete all assessments and required study sessions
Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention
Time frame: 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.
10 secondary outcomes
Arthritis Pain (AIMS 2 Symptom Subscale)
Time frame: Baseline, post-treatment (6 weeks)
Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)
Time frame: Baseline, post-treatment (6 weeks)
Psychological Distress (AIMS 2 Affect Subscale)
Time frame: Baseline, post-treatment (6 weeks)
Daily Step Count in 7 Day Period
Time frame: Baseline, post-treatment (6 weeks)
Rapid Assessment of Physical Activity
Time frame: Baseline, post-treatment (6 weeks)
Psychological Flexibility
Time frame: Baseline, post-treatment (6 weeks)
Valued Living - Health Domain
Time frame: Baseline, post-treatment (6 weeks)
Valued Living - Leisure Domain
Time frame: Baseline, post-treatment (6 weeks)
Valued Living - Relationship Domain
Time frame: Baseline, post-treatment (6 weeks)
Valued-Living - Work/Community Domain
Time frame: Baseline, post-treatment (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35915512Plumb 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.
- Derived from this study: PubMed 35018370Vilardaga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Plumb Vilardaga, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engage PA and Treatment as Usual plus (TAU+) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Enrolled in the Study (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490395, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.