Physical ActivityNCT03228719
A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement
A study testing Standardize PT after TKR with a Physical Activity Intervention and Standardized PT after TKR in people with Physical Activity, run by University of Delaware at 1 site in United States.
Trial summary
Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Standardize PT after TKR with a Physical Activity Intervention and Standardized PT after TKR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2017to 21 Apr 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 45
- Seeking outpatient physical therapy for a unilateral TKR
Who cannot join
- Not interested in increasing physical activity
- Any other medical conditions that limit your physical activity
- Have had or are planning on having another leg surgery within 6 months that is unrelated to your TKR surgery
- Previously enrolled in a physical activity intervention study at this clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial
Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. This randomized clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist administered physical activity intervention for people after TKR.
Methods/Design: One hundred and twenty individuals, over the age of 45, who seek outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control and intervention group. The intervention group will receive a weekly physical activity intervention during PT, which includes a FitbitTM monitor, individualized step goals, and face-to-face feedback provided by the physical therapist. Efficacy of the intervention will be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge from PT. The association of self-efficacy for exercise and kinesiophobia with physical activity will also be measured at the same time points. Fidelity and safety of the intervention will be assessed during outpatient PT.
Discussion: This study is designed to fill a critical clinical need to increase physical activity after TKR. The primary objective of the study is to evaluate the efficacy of a physical therapist administered physical activity intervention for people after TKR. The secondary objectives are to evaluate the fidelity and safety of a physical therapist administered physical activity intervention for people after TKR and to investigate changes in self-reported and performance-based physical function after a physical therapist administered physical activity intervention for people after TKR. The tertiary objective is to explore the association of psychosocial factors with physical activity 6 and 12 months after discharge from a physical therapist administered physical activity intervention for people after TKR. The findings will be used to support a large multi-site clinical trial to test the effectiveness, implementation, and cost of this intervention.
- Conditions
- Physical Activity
- Being tested
- Standardize PT after TKR with a Physical Activity Intervention, Standardized PT after TKR
- Keywords
- Total Knee Replacement, Physical Therapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardize PT after TKR with a Physical Activity InterventionBehavioural
Standardized PT and a physical activity intervention. Participants will be provided a FitbitTM Zip within one week after enrolling in the study. Participants will self-track their steps/day using their FitbitTM Zip. Participants ≤ 3 weeks' post-operative TKR are expected to maintain and not increase steps/day. Beyond 3 weeks after surgery, step goals will be initiated and evaluated on a weekly basis. Progression of weekly steps/day goal will be a joint decision between the participant and physical therapist. As a guide, a 10-20% increase in steps/day until at least 6,000 steps/day is achieved. Each week the physical therapist will review the participant's steps/day goal and if at least 4 of the 7 previous days per week were at or above the prior week's steps/day goal, then next week's steps/day goal will increase. The physical therapist will discuss current steps/day with the participant using the Fitbit TM Zip and set a personalized steps/day goal each week during PT.
Standardized PT after TKROther
Participants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standardized Outpatient Physical Therapy after TKR Receives: Other: Standardized PT after TKR |
| Intervention Group | Experimental | Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention Receives: Behavioral: Standardize PT after TKR with a Physical Activity Intervention; Other: Standardized PT after TKR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Measured by an Actigraph GT3X Monitor
Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week
Measured: Baseline, discharge from PT, and 6 months after PT discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start24 Jul 2017
- Primary completion4 Oct 2021
- Study completion21 Apr 2022
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 Physical ActivityStudies 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel K. White, University of Delaware
- Investigators
- Daniel K White, PT, ScD, MSc, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228719
- Sponsor's protocol ID
- 946165-97
- Status last verified
- May 2025
- First submitted
- 20 Jul 2017
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christiansen MB, Thoma LM, Master H, Schmitt LA, Pohlig R, White DK. A Physical Therapist-Administered Physical Activity Intervention After Total Knee Replacement: Protocol for a Randomized Controlled Trial. Phys Ther. 2018 Jul 1;98(7):578-584. doi: 10.1093/ptj/pzy037.
PubMed 29608733
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03228719
- Acronym / sponsor ID
- 946165-97
- Conditions
- Physical Activity
- Keywords
- Total Knee Replacement, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. This randomized clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist administered physical activity intervention for people after TKR.
Methods/Design: One hundred and twenty individuals, over the age of 45, who seek outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control and intervention group. The intervention group will receive a weekly physical activity intervention during PT, which includes a FitbitTM monitor, individualized step goals, and face-to-face feedback provided by the physical therapist. Efficacy of the intervention will be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge from PT. The association of self-efficacy for exercise and kinesiophobia with physical activity will also be measured at the same time points. Fidelity and safety of the intervention will be assessed during outpatient PT.
Discussion: This study is designed to fill a critical clinical need to increase physical activity after TKR. The primary objective of the study is to evaluate the efficacy of a physical therapist administered physical activity intervention for people after TKR. The secondary objectives are to evaluate the fidelity and safety of a physical therapist administered physical activity intervention for people after TKR and to investigate changes in self-reported and performance-based physical function after a physical therapist administered physical activity intervention for people after TKR. The tertiary objective is to explore the association of psychosocial factors with physical activity 6 and 12 months after discharge from a physical therapist administered physical activity intervention for people after TKR. The findings will be used to support a large multi-site clinical trial to test the effectiveness, implementation, and cost of this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standardized PT after TKRStandardized Outpatient Physical Therapy after TKR |
| Intervention Group | Experimental | Behavioral: Standardize PT after TKR with a Physical Activity Intervention, Other: Standardized PT after TKRStandardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 45
- Seeking outpatient physical therapy for a unilateral TKR
Key exclusion criteria (4 listed)
- Not interested in increasing physical activity
- Any other medical conditions that limit your physical activity
- Have had or are planning on having another leg surgery within 6 months that is unrelated to your TKR surgery
- Previously enrolled in a physical activity intervention study at this clinic
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 |
|---|---|---|
| Standardize PT after TKR with a Physical Activity InterventionStandardized PT and a physical activity intervention. Participants will be provided a FitbitTM Zip within one week after enrolling in the study. Participants will self-track their steps/day using their FitbitTM Zip. Participants ≤ 3 weeks' post-operative TKR are expected to maintain and not increase steps/day. Beyond 3 weeks after surgery, step goals will be initiated and evaluated on a weekly basis. Progression of weekly steps/day goal will be a joint decision between the participant and physical therapist. As a guide, a 10-20% increase in steps/day until at least 6,000 steps/day is achieved. Each week the physical therapist will review the participant's steps/day goal and if at least 4 of the 7 previous days per week were at or above the prior week's steps/day goal, then next week's steps/day goal will increase. The physical therapist will discuss current steps/day with the participant using the Fitbit TM Zip and set a personalized steps/day goal each week during PT. | Behavioural | Intervention Group |
| Standardized PT after TKRParticipants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks. | Other | Control Group, Intervention Group |
Primary outcome
Physical Activity Measured by an Actigraph GT3X Monitor
Time frame: Baseline, discharge from PT, and 6 months after PT discharge
Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29608733Christiansen MB, Thoma LM, Master H, Schmitt LA, Pohlig R, White DK. A Physical Therapist-Administered Physical Activity Intervention After Total Knee Replacement: Protocol for a Randomized Controlled Trial. Phys Ther. 2018 Jul 1;98(7):578-584. doi: 10.1093/ptj/pzy037.
- 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.
Daniel K White, PT, ScD, MSc principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardize PT after TKR with a Physical Activity Intervention and Standardized PT after TKR in people with Physical Activity, run by University of Delaware 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 2 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 11 May 2025. 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 11 May 2025). 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?
Physical Activity Measured by an Actigraph GT3X Monitor (time frame: Baseline, discharge from PT, and 6 months after PT discharge). 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 NCT03228719, 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 11 May 2025.