Knee ArthroplastyNCT03768206
The PATH Study to Promote Physical Activity After Knee Replacement
A study testing Standard Physical Therapy, Physical therapist discuss aerobic physical activity and Physical activity session in people with Knee Arthroplasty, run by University of South Carolina at 2 sites in United States.
Trial summary
The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility. 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?
- Standard Physical Therapy, Physical therapist discuss aerobic physical activity and Physical activity session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jan 2019to 15 Jun 2020
- 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
- Have had a knee replacement in the last 2 months
- Be willing to wear and accelerometer for 7 days during assessments
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palmetto Health- USC Orthopedic Center
Columbia, South Carolina, 29203
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Promoting Physical Activity Via Physical Therapist Following Knee Replacement- The PATH Study
The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.
Read the detailed description
Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.
- Conditions
- Knee Arthroplasty
- Being tested
- Standard Physical Therapy, Physical therapist discuss aerobic physical activity, Physical activity session
- Keywords
- knee arthroplasty, behavioral intervention, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical TherapyBehavioural
Participants will receive standard outpatient physical therapy that is typical following knee replacement
Physical therapist discuss aerobic physical activityBehavioural
Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.
Physical activity sessionBehavioural
Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
| Study group | Role | What they receive |
|---|---|---|
| PATH | Experimental | PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity \& assist with goal setting during therapy sessions. Receives: Behavioral: Standard Physical Therapy; Behavioral: Physical therapist discuss aerobic physical activity |
| PATH-12 | Active comparator | PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Receives: Behavioral: Standard Physical Therapy; Behavioral: Physical activity session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled
Feasibility will be determined based on the number of participants enrolled vs. the number approached
Measured: Baseline
Percentage of Participants Who Complete the 12 Week Assessment
Acceptability will be determined by the percentage of participants completing the 12 week assessment.
Measured: 12 weeks
Secondary outcomes (1)
Moderate-Vigorous Intensity Physical Activity
Total number of minutes of objectively-measured moderate-vigorous intensity (>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start14 Jan 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT03768206
- Sponsor's protocol ID
- Pro00081254
- Status last verified
- Jul 2021
- First submitted
- 5 Dec 2018
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the preliminary nature of the study and small sample size, we do not plan to share data with others, unless requested to do so.
Publications
Pellegrini CA, Brown D, DeVivo KE, Lee J, Wilcox S. Promoting physical activity via physical therapist following knee replacement: A pilot randomized controlled trial. PM R. 2023 Aug;15(8):965-975. doi: 10.1002/pmrj.12895. Epub 2022 Dec 15.
PubMed 36106651
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity Via Physical Therapist Following Knee Replacement- The PATH Study
- ClinicalTrials.gov ID
- NCT03768206
- Acronym / sponsor ID
- Pro00081254
- Conditions
- Knee Arthroplasty
- Keywords
- knee arthroplasty, behavioral intervention, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Prisma Health-Midlands
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 19 Jul 2021
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 feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.
Detailed description
Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATH | Experimental | Behavioral: Standard Physical Therapy, Behavioral: Physical therapist discuss aerobic physical activityPATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity \& assist with goal setting during therapy sessions. |
| PATH-12 | Active comparator | Behavioral: Standard Physical Therapy, Behavioral: Physical activity sessionPATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 40-79 years of age
- Have had a knee replacement in the last 2 months
- Be willing to wear and accelerometer for 7 days during assessments
- Be English speaking
Key exclusion criteria (3 listed)
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
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 |
|---|---|---|
| Standard Physical TherapyParticipants will receive standard outpatient physical therapy that is typical following knee replacement | Behavioural | PATH, PATH-12 |
| Physical therapist discuss aerobic physical activityPhysical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement. | Behavioural | PATH |
| Physical activity sessionParticipants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement. | Behavioural | PATH-12 |
Primary outcome
Number of Participants Enrolled
Time frame: Baseline
Feasibility will be determined based on the number of participants enrolled vs. the number approached
Percentage of Participants Who Complete the 12 Week Assessment
Time frame: 12 weeks
Acceptability will be determined by the percentage of participants completing the 12 week assessment.
1 secondary outcome
Moderate-Vigorous Intensity Physical Activity
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36106651Pellegrini CA, Brown D, DeVivo KE, Lee J, Wilcox S. Promoting physical activity via physical therapist following knee replacement: A pilot randomized controlled trial. PM R. 2023 Aug;15(8):965-975. doi: 10.1002/pmrj.12895. Epub 2022 Dec 15.
- Individual participant dataSharing planned: No. Given the preliminary nature of the study and small sample size, we do not plan to share data with others, unless requested to do so.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physical Therapy, Physical therapist discuss aerobic physical activity and Physical activity session in people with Knee Arthroplasty, run by University of South Carolina at 2 sites 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 4 inclusion and 3 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 19 Jul 2021). 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 (time frame: Baseline). 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 NCT03768206, 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 21 Jul 2021.