Increasing Physical Resilience in Older Adults With Osteoarthritis Pain: Feasibility and Acceptability of a Brief Behavioral Physical Activity Intervention
Phase: NA
Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
Just In Time: Increasing physical resilience in older adults with osteoarthritis pain: Feasibility 
and acceptability of a brief behavioral physical activity intervention 
 
Document Date: 07/19/2022 
 
NCT04490395 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
The pilot feasibility study is a small randomized trial (N=50) with an intervention group 
receiving a brief Engage protocol that focuses on physical activity (Engage-PA; n=25) as 
compared to treatment as usual plus personal fitness-tracker control (TAU+; n=25) for older 
adults with OA-pain. The intervention group will receive two 45 minute sessions over the 
course of three  weeks, receiving a novel combination of three theoretically critical elements: 1) 
personal feedback from physical activity monitoring using wearable fitness-tracker device, 2) 
increasing motivation through linking physical activity goals to deeply held personal values for 
living a meaningful life, and 3) a form of pacing called the Activity Rest Cycle which involves 
setting physical activity goals using strategic cycles of timed activity and ever-shortening rest 
periods designed to prevent episodes of severe pain while also increasing stamina. Physical 
activity will be measured by personal fitness tracker, Garmin VivoFit 4.0 for all participants 
throughout the study.  
 
Aim1: Examine the feasibility and acceptability of Engage-PA in a sample (N=50) of 
adults ≥ 65 with OA-related pain. Feasibility will be measured by meeting ≥75% study accrual 
(H1a) and ≤ 20% attrition (H1b), and adherence will be measured by use of fitness-tracker for 
75% of days participating in the study (H1c). Acceptability will be measured by ≥ 80% 
participant satisfaction (H1d) on a standardized self-report measure utilizing both qualitative 
and quantitative assessment (i.e., Client Satisfaction Questionnaire-8).  
 
Aim 2: Examine indicators of improvement over time (baseline and post-treatment) and 
between groups via patterns of daily steps (H2a), self-reported pain-related disability (H2b) and 
psychological well-being (H2c). We anticipate that Engage-PA participants will show patterns of 
improvement at follow up as compared to those in the TAU+ group (H2a-c). 
 
Background & Significance 
 
Osteoarthritis (OA) is one of the most common age-related problems facing older 
adults, often leading to reductions in recommended physical activity. Physical activity has been 
shown to prevent disability across large samples of older adults and is safe for even vulnerable 
older adults. Yet, there are often significant barriers to regular physical activity for older adults 
with OA, including persistent pain and numerous psychosocial factors. For older adults, OA is 
often a progressive, degenerative condition, and as such physical functioning is often on a 
trajectory of decline. Older adults with persistent OA-related pain are at particular risk for more 
complications and poorer functional outcomes from joint replacement surgery, and the rate of 
complications and mortality from problematic opioid therapy (e.g., chronic, high dose) in older 
adults is increasing. 
 

Physical resilience can slow the concomitant decline in function and activity related to 
OA. Physical resilience for older adults with OA pain can be defined as increasing physical 
mobility and decreasing pain-related disability.  A trajectory of physical resilience is critical for 
ongoing independence in older adults with OA because decreased mobility and persistent pain 
are associated with worse outcomes for living independently and lack of exercise can 
exacerbate other common health conditions. Given the prevalence of OA, the often 
degenerative course of OA, and the specific risks with medical treatment approaches for older 
adults, there is much enthusiasm for the development and testing of innovative behavioral 
approaches to improving physical resilience in this population.  
 
Our team has developed an enhanced pain coping skills protocol (i.e., Engage) to better 
meet the needs of older adult populations. Engage is brief, and counselors teach participants 
behavioral pain coping skills (such as strategic use of activity pacing for increasing physical 
activity) along with additional psychological coping skills such as linking behavior change to 
deeply held personal values. Previous work testing the Engage protocol demonstrated 
improvements in pain-related disability for patients with advanced cancer, many of whom were 
older adults. We propose to extend previous work by increasing our focus on physical activity 
within the Engage protocol for adults ≥ 65 with persistent OA-related pain. Specifically, we will 
integrate the behavioral physical activity component of Engage with physical activity 
monitoring using wearable technology and tailor it for older adults with OA. This critical step 
will provide important data to support the testing of a brief, adapted protocol for this 
population. 
 
Engage-PA will leverage technology, strategic activity pacing and goal setting, and 
linking physical activity goals (i.e., average daily steps walked) to meaningful personal values 
clarification (e.g., enhancing the quality of time spent with grandchildren) to increase physical 
resilience via physical activity in older adults. The integration of these particular physical activity 
components for this population is novel. While existing protocols for enhancing physical activity 
in this population may utilize activity pacing types of interventions along with other 
psychological coping strategies, none to date have incorporated such a strategic focus on 
deepening personally meaningful values as a means of increasing motivation with those 
methods. Further, we are integrating these behavioral strategies while also providing 
participants with ongoing direct feedback on their physical activity from their personal fitness 
tracker that can be discussed with a provider as an additional source of positive accountability 
for physical activity goal setting. Such technology extends the intervention by bringing it into 
participants’ daily life, maximizing the potential for positive behavior change from even brief 
counseling support. 
 
Both qualitative and quantitative data will assist us in learning about the acceptability of 
this brief Engage-PA protocol that is designed in a way that is likely highly implementable. This 
critical step will provide important data to support further testing of an optimized Engage-PA 

protocol for improving physical resilience via increases in physical activity and decreases in 
pain-related disability in older adults with OA-pain. The current study is in line with our long 
term goal of disseminating brief, accessible, evidence-based interventions to improve physical 
resilience in older adults through increases in physical activity, reduced pain-related disability, 
and reduce reliance on opioid pain medications. 
 
Design & Procedures 
 
This small randomized study will assess the feasibility and acceptability of a brief 
intervention to increase physical resilience in older adults with OA pain. Participants will engage 
in baseline and post-treatment assessments.  
 
Measures. Age, race/ethnicity, marital status, medical comorbidities, exercise patterns, 
medical care utilization, height and weight, use of pain medications, and COVID-19 impact will 
be collected via self-report and electronic medical record review. Screening: Recruitment 
Screening phone script uses items from the Physical Activity Readiness Questionnaire Plus 
(January, 2020 version) tailored for this study to assist in assessing for eligibility and safe 
participation, and assist staff in determining if participants need to discuss exercise with their 
medical team prior to enrolling in the study. Folstein Mini-Mental Status Exam will be utilized to 
determine if participants have more than mild cognitive impairment that could prevent safe 
participation in the study. A cut off score of 19 will be used, which is the lower bound of mild 
cognitive impairment. Clinical Tool: Rating of Perceived Exertion scale. This is a 0-10 scale with 
anchors for personally-determined exertion levels as participants engage in activity. Primary 
Outcomes. Feasibility will be measured by recruitment rate, at least 75% accrual (N=50), 
retention (≤ 20% attrition), and adherence as measured by use of fitness-tracker for ≥ 75% of 
days participating in the study. Acceptability will be measured by ≥ 80% of participants 
reporting being “very satisfied” with the program using a standardized measure, the Client 
Satisfaction Questionnaire. Secondary outcomes will be collected at baseline, post-treatment, 
and 1 month follow up. Physical resilience will be measured via Garmin fitness tracker daily 
steps tracked for 7 consecutive days at each timepoint and continuously throughout the study. 
Pain-related disability will be assessed with the self-reported Arthritis Impact Measurement 
Scale (AIMS) which assesses functioning across several areas such as physical mobility, social 
activity, and activities of daily living. Psychological well-being will be measured by 1) the AIMS 
Mood and Tension subscales, which measure depression and anxiety, 2) Bulls-Eye Values 
Survey where participants are asked to rate how successful they have been in living consistent 
with personal values across life domains of health, relationships, work/community, and leisure, 
and 3) The Acceptance and Action Questionnaire-II, which is a 7-item questionnaire assessing 
psychological flexibility, which is a common measure used to assess psychological well-being. 
The Coronavirus Impact Scale will rate the impact of the COVID-19 pandemic, and was 
developed to widely cover types of adversities individuals’ experienced secondary to the 
pandemic. The scale is used commonly in numerous large studies in response to clinical and 

research needs from the COVID-19 pandemic. The COVID changes to exercise and sitting 
questionnaire contains 3 items to assess changes of individuals’ activity levels from COVID-19. 
 
Screening procedures. After DEDUCE query identifying older adults with osteoarthritis 
diagnosis served in Duke Clinics, potential participants will be a) emailed a link to take the Pre-
Screen Survey in Redcap and research staff will follow up by phone using Recruitment Phone 
Script to finalize eligibility, or b) mailed a Recruitment Letter and interest and eligibility will be 
confirmed in a follow up phone call by study staff using the Recruitment Phone Script. The 
Recruitment Phone Script reviews inclusion and exclusion criteria, and also asks several 
questions about unmanaged medical conditions that might contraindicate safe participation; in 
which case study members will directly contact potential participants’ medical teams for 
confirmation that their patient’s health is managed and gain approval to enroll in the study that 
would require the physical activity of walking. Potential participants will be encouraged to 
discuss walking and/or other exercise with their medical team prior to enrolling in the study as 
well.  
 
Enrollment and assessment procedures. Interested participants will meet with study 
staff to conduct informed consent and complete the baseline assessment, and then be 
randomized to either Engage-PA or TAU+. All participants will complete self-report 
questionnaires at baseline and post-treatment. Self-report data using measures as listed above 
will be collected online using RedCAP or paper/pencil. All participants will be given a personal 
fitness-tracker (ie., Garmin ViVoFit) at baseline for use throughout the study, with instructions 
on how to write down daily steps for 7 consecutive days at baseline and post-treaatment 
assessments, as well as continuous measures of daily steps in the intervening period. Number 
of daily steps as read by the Garmin will be collected via paper and pencil and sent to study 
staff via telephone, text, email or participants can come to the research staff offices for syncing 
and daily steps data will be recorded directly from the Garmin devices and devices then 
returned to participants. All daily steps data will be de-identified and coded using a Study ID. 
Data will be collected on Duke servers and managed by Duke study staff. This data will be 
collected and stored using a unique Study ID, and will not include PHI.  Participants will be 
compensated for their time completing both assessments ($30 each, for up to $60).  
 
Engage-PA Intervention. Engage-PA participants will attend two 45-minute sessions with 
a study therapist two weeks apart.  Session 1. Participants will learn to apply the Activity-Rest 
Cycle for strategic pacing of physical activity while also avoiding extreme pain, and this practice 
is graded to increase stamina over time. Participants will select a physical activity (e.g., 
walking), and set a specific physical activity goal (e.g., walk for 10 minutes two times per day) 
for practice between sessions. Participants may choose to walk or exercise in their homes or 
communities at times and places of their choosing. Participants will be coached on the use of 
the Rating of Perceived Exertion Scale for rating how intense they experience walking or other 
exercise. Participants will be encouraged to keep their perceived exertion level at or below 5 on 

a 10 point scale (10 being the max exertion), unless they had previously engaged in a vigorous 
activity program or have discussed initiating a new physical activity (other than walking) with 
their doctor. They will also be encouraged to continue monitoring any medical conditions using 
at-home monitoring devices as recommended by their treating medical team (e.g., blood 
pressure cuff, glucose monitors) if they had previously been using those monitoring devices. 
They will also identify and clarify deeply meaningful personal values (e.g., connection with 
loved ones) as motivation for increasing physical activity. Participants will link their personal 
values to their physical activity goals either directly (e.g., playing with grandchildren, walking 
the dog) or indirectly (e.g., being healthier furthers such activities as helping others, spending 
quality time with friends, being less dependent on others and increased financial stability, etc.). 
Session 2. Participants will review their personal exercise goal using their personal fitness 
monitor data with the study therapist, troubleshoot issues using the Activity-Rest Cycle, further 
clarify personal values for increasing physical activity, and set longer term physical activity 
goals. Participants may choose to walk or exercise in their homes or communities at times and 
places of their choosing. Study sessions will be audio recorded using a Duke issued tablet 
device.  
 
TAU Plus Personal Fitness Tracker condition.  The treatment as usual group will be 
monitoring only. They will continue to receive standard care throughout the study, and there 
will be no intervention. They will be given a personal fitness monitor as a continuous 
monitoring device for the steps walked. They will be given basic instructions on the device's use 
and data from the device will be collected (only during the study period). They will not be asked 
to engage in any particular form of exercise, or specifically be asked to increase their walking. 
However, they will be given the Ratings of Perceived Exertion Scale, and informed that study 
members will contact their medical team before they initiate a new exercise program to gain 
permission of enrolling in a study that will increase or start physical activity, and participants 
will be encouraged to talk to their doctor if they plan to engage in activity above a 5/10 on the 
RPE Scale. They will also be encouraged to continue monitoring any medical conditions using at-
home monitoring devices as recommended by their treating medical team (e.g., blood pressure 
cuff, glucose monitors) if they had previously been using those monitoring devices. They will 
not receive the 2 session intervention protocol, and no specific goals for steps or other activity 
will be set by the study staff. 
 
Selection of Subjects 
  
We plan to enroll a maximum of 50 adults age 65 or older with a diagnosis of OA in the 
knee or hip who are currently served by Duke clinics. Letters will be mailed to potentially 
eligible patients identified through electronic health records (i.e., DEDUCE) and follow up phone 
calls will assess participant interest and conduct eligibility screening. Our study team has 
successfully recruited using these methods in large, NIH funded behavioral pain management 
trials. 

 
Eligible participants:  
• age 65 or older 
• English speaking 
• diagnosis of osteoarthritis in knee or hip (as verified by medical record review) 
• able to ambulate even if assisted with 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 (i.e., due to dementia) 
subsequently informed by a Folstein Mini-Mental Status Examination of <19 
 
Subject Recruitment and Compensation 
 
We plan to enroll a maximum of 50 adults age 65 or older with a diagnosis of OA in the 
knee or hip who are currently served by Duke clinics. Potential participants will be identified 
using electronic medical record from the PACE-DEDUCE query. Duke clinics will be included as a 
search variable along with other inclusion criteria per protocol. Once identified, potential 
participants will be emailed to inform them of the study and sent a REDCap Pre-Screening link 
to the study Pre-Screening survey and asked to provide their contact information if eligible and 
interested in learning more. The Pre-Screening Redcap Survey asks potential participants items 
1-9 from the Recruitment Phone Script (dated 6/10/2020). Study staff will follow up with 
potentially eligible participants via email, telephone, or postal mail, and they will be invited to 
enroll if they are interested and fully eligible based on the Recruitment Phone Script questions. 
Depending on recruitment response, we will also send Recruitment Letters via USPS, and 
finalize eligibility with the Recruitment Phone Script. Responses to unmanaged health 
conditions assessed from the Recruitment Phone Script, may result in study members 

contacting potential participants' medical teams for confirmation that their patient’s health is 
managed and gain approval to enroll in the study that would require the physical activity of 
walking.  Primary care teams will be contacted first, and if needed, specialty care providers will 
be contacted. DEDUCE pulls organized by Duke Primary Care clinics will be used to identify 
potential participants with OA, and as such, all potential participants shall have seen a Duke 
PCP. If a provider requests a release of information, patients will be provided one to sign to 
permit the discussion of their health information solely for the purpose of determining 
eligibility if they so choose. 
 
Informed consent procedures will be conducted either in person, online using REDCap 
or via phone. Once informed consent has been received, participants will be scheduled for a 
study appointment either to happen at that time or a time convenient for them in the future. A 
member of the study team will conduct the appointment. If a participant declines study 
participation at any point during these procedures, the information provided to the study team 
through DSR/DEDUCE/Maestro will be immediately de-identified. At this first study 
appointment, the study team member will explain all study procedures and administer the 
baseline assessment. After the patient has consented and completed the baseline assessment, 
they will be randomized to either receive: 1) Engage-PA or  2) Treatment As Usual plus use of 
personal fitness tracker.  
 
Based on previous work with this population, we expect that approximately 50% of the 
sample to be male and 50% female. Based on the ethnic make-up of patients coming to Duke 
clinics, we anticipate that the ethnic make-up of the sample will likely include Caucasian (75%), 
African-American (15%), Asian (5%) and Hispanic (5%). Recruitment efforts will focus on actively 
seeking to attract an ethnically diverse sample representative of demographics of the local 
recruitment area. 
 
Participants will be compensated $30 for their time when they participate in baseline 
and post-treatment assessments, for a total of up to $60 per participant.  
 
Risk/Benefit Assessment 
 
Include a thorough description of how risks and discomforts will be minimized (per 45 
CFR 46.111(a) (1 and 2)). Consider physical, psychological, legal, economic and social risks as 
applicable. If vulnerable populations are to be included (such as children, pregnant women, 
prisoners or cognitively impaired adults), what special precautions will be used to minimize 
risks to these subjects? Also identify what available alternatives the person has if he/she 
chooses not to participate in the study. Describe the possible benefits to the subject. What is 
the importance of the knowledge expected to result from the research? 
 

Potential medical risks and discomforts: We do not anticipate any significant medical 
risks or discomforts for participants in the study. Older adults with OA-related pain are 
frequently encouraged to increase their exercise and physical mobility (e.g., walking) as a 
means of improving health and wellness; physical activity is recommended for all older adults 
by the World Health Association (WHO, 2020) and is associated with positive health outcomes 
such as pain reduction and improved overall health and wellbeing in OA populations (Kanavaki 
et al, 2017; Pahor et al 2014; Singh, 2002). The addition of behavioral pacing strategies in the 
protocol is aimed at providing participants with a way to strategically increase walking/exercise 
without creating severe pain, though some pain may be present with physical movement. There 
is some minimal risk of exercise-related injuries or falls if participants choose to walk or exercise 
at home or in their own community environments. The potential benefits of increased walking 
or other forms of exercise for older adults outweigh such risks. Participants may choose not to 
walk at any time, and may cease participating at any time for any reason. All participants will 
continue to receive standard health care throughout the study. No participant will be asked to 
change or decline any strategies for pain management based on their participation in this study. 
 
Psychological risk and discomfort: The study is not targeting treatment of psychiatric 
illnesses, and as such we do not anticipate that the participants will be at increased risk of 
suicidality, self-harm, or harm to others. The PI is a licensed clinical psychologist and supervisor 
currently in practice here at Duke with the expertise to manage clinical issues related to 
imminent safety if they arose. A situation in which a study participant is at imminent risk of 
harming him/herself or others may necessitate involuntary reporting and intervention. This risk 
of loss of confidentiality will be discussed and disclosed to potential participants at the time of 
consenting.  Some of the questions asked during the assessments or issues addressed during 
the intervention may make some participants uncomfortable. Participants will be told that they 
may refuse to answer any of the questions and that they may stop participation in this study at 
any time.  If a participant reports high levels of emotional distress or psychological symptoms 
(depression, anxiety), a licensed clinical psychologist (Dr. Plumb Vilardaga) will provide patient 
consultation and referral for appropriate treatment.  
 
Other risks: The other risks of this study are those associated with confidentiality. In any 
research project of this type, there is some risk attendant to confidentiality of self-report data. 
To ensure confidentiality of data, all records will be identified by the participant's identification 
number, not by name. All raw data will be kept in a locked file cabinet. Protocols and 
completed measures will be coded by number only, for the purpose of data tabulation and 
analysis. Data will be stored in protected research computer servers /systems at Duke which 
employ strict procedures to ensure subject confidentiality. All data will be entered into the 
computer by study staff only, utilizing code numbers only for subject identification. All 
information given by the participants will be kept confidential unless otherwise required by law 
to disclose such information.  
 

Potential Benefits of Proposed Research to Human Subjects and Others.  
Participants may gain strategies and skills to help them improve their physical resilience 
(defined as increased physical mobility and decreased pain-related interference) and 
psychological wellbeing as a result of participating in the intervention. The information gained 
from this study will provide much needed information for future work disseminating brief, 
accessible protocols for improving physical resilience in response to a chronic health condition 
such as persistent pain from OA in older adult populations.  
 
Data Analysis & Statistical Considerations 
 
Sample Size and Power: Sample size of N=50 has been chosen based on effect sizes 
estimated from previous studies using similar behavioral approaches for these outcome 
variables, and after accounting for a maximum 20% attrition rate, resulting in N=40 effective 
number of participants.  
 
Analysis: Descriptive statistics will be used to characterize the primary feasibility and 
acceptability outcomes.  To identify types of physical activity are trending toward change, 
mixed model analyses or functional data analysis in line with current data analytic 
recommendations will be used to assess changes average daily steps over time. Missingness of 
data will be examined and accounted for using recommended models, including intent-to-treat, 
where appropriate for secondary outcomes such as the self-report psychological outcome 
variables.