- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799772
The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA
The Feasibility of a Comprehensive Behavioral Intervention in Patient Post Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Unilateral TKA at least three months prior to, but no longer than six months prior to study participation;
- Surgical technique was a minimally invasive (quadriceps sparing) TKA performed by the same experienced surgeon;
- Provide a written medical clearance to participate in the study;
- Speak fluent English;
- Are older than 50 years.
Exclusion Criteria:
- Have bilateral or TKA revision;
- Have hip or ankle joint replacement;
- Are unable to comfortably bear weight on the surgical knee;
- Had 2 or more falls within past year;
- Have uncontrolled medical condition that would prevent safe participation in the study (uncontrolled blood pressure, dyspnea at rest, cardiovascular disease, absolute contraindications to exercise, and diabetes);
- Participating in regular exercise during prior 6 months;
- Use beta blockers,
- Have a neurological condition that affects locomotion;
- Have had a malignancy, life-threatening illness or surgery in the past six months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comprehensive behavioral intervention
It will involve regular contacts over 6 month period. It will include 2 weekly contacts for weeks 1-6, weekly contacts for weeks 7-8, bi-weekly contact for months 3-4, and monthly contact for months 5-6. There is a combination of 20 individual and group-based sessions. It is a combination of 4 components: a) Evidence-based exercise program, b) Physical activity promotion, c) Healthy nutrition guidance, and d) Self-management. |
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Active Comparator: Standard of Care Exercise Program (SCE)
The SCE will be delivered by a physical therapist.
It represents the typical rehabilitation after TKA surgery.
It is expected to provide small and short-lived functional improvement.
Subjects will participate in 12 supervised sessions (2 x/week, for 6 weeks).
The SCE consists of: a) lower extremity range of motion and stretching exercises, b) lower extremity strengthening exercises of moderate intensity, and d) endurance exercises using treadmill.
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Typical rehabilitation after TKA surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Self-reported physical function
Time Frame: 6 months
|
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index - Physical Function scale (WOMAC-PF) at 6 months.
|
6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Performance-based physical function
Time Frame: 6 months
|
Change from Baseline in Self-selected gait speed at 6 months.
|
6 months
|
Change from Baseline in Performance-based Physical Function
Time Frame: 6 months
|
Change from Baseline in Timed 5 chair rise at 6 months.
|
6 months
|
Change from Baseline in Performance-based Physical Function
Time Frame: 6 months
|
Change from Baseline in single leg balance time at 6 months.
|
6 months
|
Change from Baseline in Performance-based Physical Function
Time Frame: 6 months
|
Change from Baseline in timed ascend/descend stair test at 6 months.
|
6 months
|
Change from Baseline in Performance-based Physical Test
Time Frame: 6 months
|
Change from Baseline in 6 minutes walk test at 6 months.
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6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in measures of physical activity
Time Frame: 6 months
|
Change from Baseline in measures of physical activity taken by a portable activity monitor at 6 months.
|
6 months
|
Change from Baseline in measures of General Health Status
Time Frame: 6 months
|
Change from Baseline in the Medical Outcomes Survey 36-Item Short-Form Health Survey at 6 months.
|
6 months
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Change from Baseline in measures of physical activity
Time Frame: 6 months
|
Change from Baseline in measures of physical activity taken by a self-reported questionnaire (CHAMPS) at 6 months.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara R Piva, PT, PhD, University of Pittsburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PRO11030404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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