Energize! Internet-Delivered Physical Activity Program for Adults With Knee Replacement
Phase: NA
Conditions: Knee Arthroplasty
Sponsor: University of South Carolina

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Study Title: Energize! Internet-Delivered Physical Activity Program for Adults with Knee 
Replacement 
 
Principal Investigator Name:  Christine A. Pellegrini, PhD 
 
Funding: This work was supported by an ASPIRE grant from the Office of the Vice President 
for Research at the University of South Carolina.  
 
Clinical Trials Identifier: NCT06096727 
Date: 9/4/2023 
 
 
 

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A. SPECIFIC AIMS  
 
Aim 1: Examine the effects of an internet-based physical activity program on moderate to 
vigorous intensity physical activity (MVPA), pain, self-reported physical function, sleep 
disturbance, cognitive function, and psychosocial constructs in adults with TKR at 3 months 
(post-intervention) and 6 months (maintenance).   
Hypothesis: Participants randomized to Energize! will engage in more MVPA, have 
less pain and sleep disturbance, better physical and cognitive function at 3 months as 
compared to those in Delayed Energize!.   
Aim 2: Examine the acceptability of the Energize! Exercise Program by assessing adherence 
to the intervention (number of video lessons viewed, planning and reporting of exercise 
minutes, completion of homework assignments) and participant satisfaction ratings. 
Aim 3: Explore the maintenance effects of an internet-based physical activity program on 
moderate to vigorous intensity physical activity (MVPA), pain, self-reported physical function, 
sleep disturbance, and cognitive function in adults with TKR at 6 months (maintenance) among 
those randomized to the immediate Energize! condition.   
 
B. BACKGROUND AND SIGNIFICANCE 
 
 
More than 4 million adults ≥50 years are living with a total knee replacement (TKR).1 TKR 
utilization in the US continues to increase dramatically across all ages, with over 615,000 TKR 
completed annually.2 The number of new TKR’s is expected to approach 3.48 million by 2030.3 
TKR substantially increases lifetime medical costs and accounts for 61% of osteoarthritis-
related direct medical costs.4 Hospital-based costs of TKR exceed $16 billion.5 With the 
dramatic expected rise of TKR utilization over the next 20 years3 and substantial burden on the 
economy, it is imperative to identify approaches to maximize the benefits of this costly 
treatment.   
While TKR can improve health-related quality of life,6 pain,7 and physical function8, less than 
5% of adults with TKR reach recommended physical activity guidelines after surgery, and 
physical activity levels at 1 year post-surgery remain similar to pre-operative levels.9,10 The 
continued low levels of physical activity are concerning because inactivity is associated with 
increased risk of mortality11 and chronic disease,12,13 as well as lower quality of life14 and 
poorer physical function.15,16 Further, while undergoing TKR initially reduces overall mortality, 
within the decade following surgery, adults with TKR are at higher risk for death from 
dementia17 and cardiovascular disease18 as compared to adults without TKR. In particular, 
~70% of deaths that occurred ≥10 years after TKR are due to cardiovascular diseases, 
Alzheimer’s disease, and dementia.19 Although exact reasons for the excess mortality in this 
population are unknown,19 increased physical activity after TKR may help prevent or delay the 
development of cardiovascular disease,20,21 dementia,20,21 and Alzheimer’s disease.20  
As a result, there has been an increase in the number of interventions targeting increased 
physical activity after TKR, but increases in physical activity have been small to modest (e.g., 
increase of 1,164 to 1,808 steps or 39-73 minutes of moderate intensity activity).22–24 It has 
been hypothesized that many of these programs have had limited success because they were 
implemented too soon after surgery (this includes our ASPIRE-I trial),25 as evidence suggests 
that physical impairments, activity limitations, and social participation restrictions continue to 

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occur throughout the first 12 months post-TKR.26 Further, it is estimated that at least 20% of 
adults after TKR still experience significant pain beyond this period.27 Prior research also 
suggests that interventions which have had the greatest impact on physical activity have been 
too costly or burdensome to implement within clinical care.22,23 Therefore, low-cost physical 
activity programs that could be implemented when adults with TKR are completely recovered 
from surgery are critical for addressing the low levels of physical activity observed in this 
population and reducing their increased risk for cardiovascular disease and dementia. 
The Energize! Exercise Program is 3-month fully-automated internet-based physical activity 
program, which is guided by the Multi-Process Action Control (M-PAC) framework,28 and 
represents a low-cost and highly disseminable approach for targeting physical activity in TKR 
patients, particularly given that over 91% of adults have access to the internet.29 Preliminary 
results suggest high feasibility, acceptability, and initial efficacy of this program for increasing 
activity among inactive adults; however, it has not been tested in adults with TKR. Due to 
potential physical limitations and comorbidities, those with TKR are often excluded from 
physical activity programs, despite being a growing and high-risk population.  
 
C. RESEARCH DESIGN AND METHODS AND DATA ANALYSIS  
 
Study Design: The proposed project is a pilot randomized controlled trial examining the 
acceptability and preliminary effects of an internet-based physical activity program on MVPA 
following TKR. A total of 50 adults will be recruited and randomized to either start the Energize! 
internet-based physical activity program immediately or at 3 months.  
 
Procedures: 
 
Screening: Participants will be screened by an online REDCap survey to ensure they meet 
study criteria. Interested and eligible participants will be scheduled for a telephone call with a 
study staff member to review study details and answer any questions participants may have 
about participation in this study.   
 
Informed Consent: Following telephone discussion with a study staff member, participants 
will be emailed a link to complete the online informed consent. To ensure the consent form is 
understandable to the study population, the consent form will be written using short sentences 
and non-technical terms, with a reading level at or below an eighth-grade level. Interested 
participants will type their name in the online approved informed consent document.  
 
Randomization: After completing the baseline assessment, participants will be randomized in 
a 1:1 ratio to either: (1) Energize! or (2) Delayed Energize!. Participants will be notified of their 
randomization and the start date of when they will start Energize!.  
 
Randomized Conditions: 
 
1.) Energize!. Prior to the start of the program, participants will attend a 30-minute webinar 
where they will be taught how to navigate the study website and given the opportunity to 
ask questions. Each week, participants will be prescribed a MVPA goal, starting at 75 
min/wk and gradually progressing to 200 min/wk by month 3.  
Participants will learn how to monitor exercise intensity and encouraged to engage in 
TKR appropriate moderate-intensity aerobic activity (e.g., brisk walking, cycling). To 

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promote a regular habit of exercise, participants will be encouraged to engage in activity 
5 days/week. 
 
Participants will watch a 10-15 minute video lesson weekly during the 3-month program. 
Topics of the lessons include exercise planning, problem solving around exercise 
barriers, exercise motivation, and thinking like an exerciser. In addition, participants will 
be encouraged to make a plan of when they will exercise and the type and duration of 
their intended activity. Action planning is predictive of health behavior change in many 
domains30 and helps to bridge the intention-behavior gap often seen with exercise.31 
Participants will report their actual activity performed daily on the study website (e.g., 
minutes/day, time of day, and type of activity) and will receive computer-generated 
personalized feedback based upon the data that was input from the previous week. 
Feedback algorithms take into account the amount of exercise performed, whether or 
not the homework assignment was completed, and whether it was an atypical week in 
terms of injury, illness or vacation. Feedback messages are designed to be encouraging 
and motivational, praising individuals for meeting goals. When goals are not met, 
support and encouragement are provided along with specific recommendations for 
behavioral strategies to implement. If participants do not report their exercise on the 
study website in a given week, an automated email reminder will be sent. 
To help participants apply the intervention content, they will be asked to complete 
homework assignments corresponding to each video lesson (~10 minutes to complete). 
Example assignments include creating routines around activity to promote habit 
formation, journaling about the value of activity in their own lives, journaling about 
positive feelings associated with activity, evaluating their progress, problem solving 
around activity barriers, and answering prompts to help them identify with being an 
‘exerciser’. 
 
2.) Delayed Energize!. Participants randomized to Delayed Energize! will receive the 
Energize! Program following the completion of the 3-month assessment.  
 
Measures: 
Assessments will be completed at baseline, 3, and 6 months. Participants will be emailed a link 
to complete surveys administered via REDCap. Additionally, participants will be mailed an 
activity monitor, activity log, and prepaid padded envelope to return the monitor following 
completion of the 7-day wear period. Participants will receive a $25 electronic gift card for 
completing each assessment. 
 
1. Physical Activity. MVPA assessed using Actigraph GT9X Link accelerometers will be 
the primary outcome. Participants will be asked to wear the monitor on their waist for 7 
days. Non-wear time will be defined as ≥90 minutes with zero activity counts, allowing 
for up to 2 minutes of <100 counts/min.32 Participants must have ≥4 days of valid wear 
time (≥10 hours/day) to be included in analyses. Participants will also be asked to 
complete a log indicating times the monitor was worn and taken off. Physical activity will 
be categorized as sedentary (<100 counts/min), light (100-2019 counts/min), and MVPA 
(≥2020 counts/min).33 Total MVPA/week will be calculated. The average number of 
steps/day will also be obtained and calculated. 
2. PROMIS. Pain intensity, pain interference, physical function/mobility, sleep disturbance, 
and cognitive function will be assessed using PROMIS computer-adaptive tests on 

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REDCap.34 These measures are commonly used, have demonstrated test-retest 
reliability, and are sensitive to change in adults with TKR.35,36 
3. EXERCISE BENEFITS/BARRIERS SCALE. Perceived exercise benefits and barriers 
will be assessed using a 43-item survey. Participants will respond to each question with 
strongly agree, agree, disagree, strongly disagree.  
4. Self-Determination Theory Constructs. Exercise Self-Identity will be assessed using 
the 9-item Self-Reported Exercise Identity Scale.37 Participants will rate on a scale from 
1 (strongly disagree) to 5 (strongly agree) their feelings relating to exercise identity. 
Examples include, “I would feel a real loss if I were forced to give up exercising” and “I 
need exercise to feel good about myself.”  Intrinsic Motivation Inventory38 assesses 
participants’ interest/enjoyment, perceived competence, effort, value/usefulness, felt 
pressure and tension, and perceived choice while performing a given activity.39 This will 
only be assessed at either 3 or 6 months, depending on randomization to Immediate or 
Delayed. Perceived Competence40 will be assessed using a 4-item survey assessing 
confidence in your ability to exercise regularly. 
5. Process Measures & Program Satisfaction. Adherence to Energize! will be 
examined over the 3-month program, including the number of video lessons viewed, 
planning and reporting exercise minutes, and completion of the homework 
assignments. Participants will complete a program evaluation to rate usefulness and 
satisfaction of program features, and their overall satisfaction with the program. 
Participants will also have an opportunity to provide an open-ended response to 
features they liked, disliked, or would want to change. These results will be used to 
inform additional future adaptations to the program. 
 
Data Analysis: Descriptive statistics will be used to describe baseline characteristics, process 
measures, and program satisfaction. Mixed ANOVA or ANCOVAs, if appropriate adjustments 
are required based on baseline characteristics, will examine the changes in physical activity 
levels (MVPA/week, steps/day) and patient-reported outcomes (PROMIS pain intensity, pain 
interference, mobility, and cognitive function) across time between Energize! and Delayed 
Energize! conditions. Although the proposed study may not be powered to detect significant 
differences, the results will allow us to collect preliminary efficacy and acceptability data, refine 
the intervention, if necessary, and determine effect sizes for future grant submissions. 
 
Data Management: All surveys will be administered online via REDCap (secure, web 
application for building and managing online surveys and database – managed by Health 
Sciences South Carolina). Any paper documents will be stored in a locked filing cabinet at the 
TecHealth Center at University of South Carolina. All computer files will be password 
protected. Only the study team will have access to the data. 
 
D. PROTECTION OF HUMAN SUBJECTS 
1.  TARGET POPULATION: 
A total of 50 adults will be recruited to participate. Participate eligibility criteria includes:  
Inclusion Criteria: The target population will include having a partial or complete TKR 
surgery ≥12 months ago, regular access to the internet, completion of baseline 
assessment measures (surveys, ≥4 days valid of activity monitoring), willingness to 
wear the accelerometer for 7 days at baseline, 3-, and 6-months, and engage in less 
than 60 minutes/week of self-reported moderate intensity exercise.  
 

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Exclusion Criteria: Participants will be excluded if they are non-english speaking, 
planning to have another surgery that limits mobility in the next 6 months, or if they have 
any other medical conditions which limits their activity.  
 
2.  RECRUITMENT PLANS:  
Participants will be recruited through numerous methods including flyers and postcards at 
physical therapy clinics and orthopedic surgeon offices in the Columbia, SC area, Research 
Match, SCresearch.org, and online and social media outlets (e.g., Facebook) that have been 
successful for recruiting older adults with arthritis. 
 
3. EXISTING DATA/SAMPLES:  
N/A 
 
4.  CONSENT/ASSENT: 
Following telephone discussion with a study staff member, participants will be emailed a link to 
complete the online informed consent. To ensure the consent form is understandable to the 
study population, the consent form will be written using short sentences and non-technical 
terms, with a reading level at or below an eighth-grade level. Interested participants will type 
their name in the online approved informed consent document and a copy of the consent can 
be emailed to participants for their records. 
 
5.  POTENTIAL RISKS: 
The risks of participating in this study are minimal; however, potential risks that participants 
may experience include: 
• 
Muscle soreness or pain from increasing physical activity after knee replacement.  
• 
An injury as a result of their physical activity. Participants are encouraged to stop exercising 
immediately if at any time they are injured or are encouraged to stop engaging in physical 
activity from their physical therapist/physician/medical professional.  
• A loss of balance and fall during exercise. 
 
6.  POTENTIAL BENEFITS: 
By taking part in this study, you may or may not experience any benefits. You may experience 
positive changes to health and mood.  Additionally, this research may be valuable for learning 
better ways to aid individuals in making healthy behavior changes after knee replacement. 
 
7.  CONFIDENTIALITY 
To ensure participants information is confidential, all participants will be assigned a study ID, 
which will be used on all paper or electronic forms. All study files will be stored in locked 
cabinets or on password-protected computer data files or secure-websites that only authorized 
study personnel can access. All results will be presented in aggregate form and participants 
will not be identified personally in any scientific report or presentation.  
 
8. COMPENSATION: 
Participants will receive $25 in the form of an electronic gift card for completing each 
assessment, which will be conducted at baseline, 3-month, and 6-month. 
 
9.  WITHDRAWAL: 
 

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Participants will be informed they can leave the research at any time without penalty. If a 
participant decides to withdraw, no more information will be collected. The participants will be 
made aware of this during the consent process. 
 
Any data collected during their participation may be used by the investigators for the purposes 
described above. Choosing not to be in the study will not result in any penalty or loss of benefit 
to which participants are entitled. Specifically, the choice not to be in this study will not 
negatively affect a participant’s right to any present or future medical treatment or his/her 
present or future employment. 
 
 

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G. APPENDIX 
Attach any additional information pertinent to the application, such as surveys or 
questionnaires, etc.