Knee ArthroplastyNCT04482400
Technology Interventions to Improve Outcomes After Knee Replacement
A study testing NEAT!2 and MyKneeGuide in people with Knee Arthroplasty, run by University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months . Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- NEAT!2 and MyKneeGuide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 25 Oct 2024
- 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 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 40-79 years of age
- Had unilateral knee replacement within last 12 months
- Have an Android or iOS smartphone that is accessible and near them the majority of the day
- Be willing to download the study applications on their smartphone
- Spend at least 7 hours/day sitting
- Be English speaking
Who cannot join
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
- Do not have ≥4 days of valid accelerometer (>=10 hours) wear at baseline.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients
The purpose of this study is to examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months .
Read the detailed description
Two 8 week technology interventions will be examined and consist of the use of an app and/or website and regular calls. Assessments to examine outcomes will be completed at baseline, as well as at 2 and 5 months.
- Conditions
- Knee Arthroplasty
- Being tested
- NEAT!2, MyKneeGuide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAT!2Behavioural
8 week sedentary reduction program
MyKneeGuideBehavioural
8 week surgery recovery education program
| Study group | Role | What they receive |
|---|---|---|
| NEAT!2 | Experimental | Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5. Receives: Behavioral: NEAT!2 |
| MyKneeGuide | Active comparator | Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5. Receives: Behavioral: MyKneeGuide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively Measured (Actigraph) Sedentary Behavior at 2 Months
sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months
Measured: 2 months
Objectively Measured (Actigraph) Sedentary Behavior at 5 Months
sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months
Measured: 5 months
Secondary outcomes (7)
Physical Function
Six minute walk test - the number of feet an individual can walk in 6 minutes.
Measured: 5 months after surgery
WOMAC Pain Subscale
WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)
Measured: 5 months after surgery
Total Physical Activity Measured by Actigraph Accelerometers
objectively measured light, moderate and vigorous activity (>= 100 counts/min) by Actigraph accelerometers
Measured: 5 months after surgery
Adherence to Calls
Number of calls completed
Measured: 2 months
Adherence to NEAT!2 App
total days NEAT! app was used
Measured: 2 months
Response to NEAT!2 Prompts
percentage of notifications in which a transition from sitting to standing was detected
Measured: 2 months
Physical Function Via Chair Stand Test
Chair stand test - how many times a participant can stand up and sit down in 30 seconds
Measured: 5 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Aug 2020
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
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 (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Prisma Health-Midlands
- Responsible party
- Principal investigator, Christine A Pellegrini, PhD, University of South Carolina
- Investigators
- Christine Pellegrini, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482400
- Sponsor's protocol ID
- Pro00092132
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2020
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be made available 12 months after the primary manuscript is published.
Publications
Pellegrini CA, Kennerley CL, Wilcox S, Lee J, DeVivo K, Horn K, Jamieson S, Hopkins J, Davis HT, Jackson Iii JB. Reducing Sedentary Time After Knee Replacement Using a Multicomponent mHealth Intervention: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 May 26;14:e83148. doi: 10.2196/83148.
PubMed 42190239
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients
- ClinicalTrials.gov ID
- NCT04482400
- Acronym / sponsor ID
- Pro00092132
- Conditions
- Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Northwestern University, Prisma Health-Midlands
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 27 Mar 2026
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 examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months .
Detailed description
Two 8 week technology interventions will be examined and consist of the use of an app and/or website and regular calls. Assessments to examine outcomes will be completed at baseline, as well as at 2 and 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEAT!2 | Experimental | Behavioral: NEAT!2Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5. |
| MyKneeGuide | Active comparator | Behavioral: MyKneeGuideParticipants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 40-79 years of age
- Had unilateral knee replacement within last 12 months
- Have an Android or iOS smartphone that is accessible and near them the majority of the day
- Be willing to download the study applications on their smartphone
- Spend at least 7 hours/day sitting
Key exclusion criteria (4 listed)
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
- Do not have ≥4 days of valid accelerometer (>=10 hours) wear at baseline.
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 |
|---|---|---|
| NEAT!28 week sedentary reduction program | Behavioural | NEAT!2 |
| MyKneeGuide8 week surgery recovery education program | Behavioural | MyKneeGuide |
Primary outcome
Objectively Measured (Actigraph) Sedentary Behavior at 2 Months
Time frame: 2 months
sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months
Objectively Measured (Actigraph) Sedentary Behavior at 5 Months
Time frame: 5 months
sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months
7 secondary outcomes
Physical Function
Time frame: 5 months after surgery
WOMAC Pain Subscale
Time frame: 5 months after surgery
Total Physical Activity Measured by Actigraph Accelerometers
Time frame: 5 months after surgery
Adherence to Calls
Time frame: 2 months
Adherence to NEAT!2 App
Time frame: 2 months
Response to NEAT!2 Prompts
Time frame: 2 months
Physical Function Via Chair Stand Test
Time frame: 5 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42190239Pellegrini CA, Kennerley CL, Wilcox S, Lee J, DeVivo K, Horn K, Jamieson S, Hopkins J, Davis HT, Jackson Iii JB. Reducing Sedentary Time After Knee Replacement Using a Multicomponent mHealth Intervention: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 May 26;14:e83148. doi: 10.2196/83148.
- Individual participant dataSharing planned: Yes. De-identified study data will be made available 12 months after the primary manuscript is published.
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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.
Christine Pellegrini, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAT!2 and MyKneeGuide in people with Knee Arthroplasty, run by University of South Carolina 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 6 inclusion and 4 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 27 Mar 2026. 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 27 Mar 2026). 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?
Objectively Measured (Actigraph) Sedentary Behavior at 2 Months (time frame: 2 months). The study lists 2 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 NCT04482400, which also lists 1 linked publication.
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 27 Mar 2026.