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Trial record 3 of 3089 for:    Recruiting, Not yet recruiting, Available Studies | Physical

A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT03228719
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel K. White, University of Delaware

Brief 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. 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-five 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.


Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Standardize PT after TKR with a Physical Activity Intervention Other: Standardized PT after TKR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Standardized Outpatient Physical Therapy after TKR
Other: Standardized PT after TKR
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.

Experimental: Intervention Group
Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention
Behavioral: Standardize PT after TKR with a Physical Activity Intervention
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.

Other: Standardized PT after TKR
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.




Primary Outcome Measures :
  1. Physical Activity measured by an Actigraph GT3X Monitor [ Time Frame: Change from baseline physical activity (initial PT evaluation), to discharge from PT (proximately 6-8 weeks after starting PT), to 6 months from PT discharge and to 12 months from PT discharge ]
    Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week. Hypothesize intervention group will spend 30 minutes or more in MVPA minutes/week than the control group and each of the follow-up time points


Secondary Outcome Measures :
  1. Fidelity of the Physical Activity Intervention [ Time Frame: At enrollment (initial physical therapy evaluation) to discharge from physical therapy (proximately 6-8 weeks after starting physical therapy) ]
    Intervention fidelity will measure the adherence of implementing the physical activity intervention in PT practice. This will be measured by reviewing the participant's home exercise program. We will check if the physical therapist documented that they reviewed the participant's physical activity using the FitbitTM and to see if they reviewed the individualized step goal with the participant in the home exercise program log.

  2. Safety of the Physical Activity Intervention [ Time Frame: AE that occur from enrollment to 12-months will document the safety of the intervention. ]
    Safety will be measured by documenting Adverse Events (AE). An AE is defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study which may or may not be related to the intervention. In the case of a major AE the principal investigator (PI) and the University of Delaware Internal Review Board (IRB) will be notified immediately. Pre-enrollment AEs will not be included in the safety assessment.

  3. Self-Reported Physical Function on the Knee Outcome Survey [ Time Frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy), ]
    Self-reported physical function will be measured on the Knee Outcome Survey (KOS). These measures will be collected via medical chart review by a research assistant.

  4. Self-Reported Physical Function on the Physical Component Summary of the Short Form Survey SF-36 [ Time Frame: At enrollment (initial physical therapy evaluation), 6 months from discharging from PT, and 12 months from discharging from PT ]
    Self-reported physical function will be measured Physical Component Summary of the Short Form Survey SF-36. These measures will be collected via medical chart review by a research assistant.

  5. Objective Measure of Physical Function on the 6 Minute Walk Test [ Time Frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy), ]
    Objective physical function will be measured using walking endurance on the 6 minute walk test (6MWT). These measures will be collected via medical chart review by a research assistant.


Other Outcome Measures:
  1. Self-reported kinesiophobia on the Fear of Movement Scale for Osteoarthritis (FMSO) [ Time Frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy), ]
    Measure of kinesiophobia for activity on the FMSO

  2. Self-reported self-efficacy using the Self-Efficacy for Exercise (SEE) [ Time Frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy), ]
    Measure self-efficacy for exercise on the SEE



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over the age of 45
  2. Seeking outpatient physical therapy for a unilateral TKR

Exclusion Criteria:

  1. Not interested in increasing physical activity
  2. Any other medical conditions that limit your physical activity
  3. Have had or are planning on having another leg surgery within 6 months that is unrelated to your TKR surgery
  4. Previously enrolled in a physical activity intervention study at this clinic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228719


Contacts
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Contact: Daniel K White, PT, ScD, MSc 3028317607 dkw@udel.edu
Contact: Tara J Manal, DPT 302-831-8893 tarajo@udel.edu

Locations
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United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19713
Contact: Daniel K White, PT, ScD, MSc    302-831-7607    dkw@udel.edu   
Sponsors and Collaborators
University of Delaware

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel K. White, Assistant Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT03228719     History of Changes
Other Study ID Numbers: 946165-4
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel K. White, University of Delaware:
Total Knee Replacement
Physical Therapy