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NCT01799772 · ClinicalTrials.gov registry record · Phase 1
The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01799772 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 50 participants.
The verdict
NCT01799772, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Patients who undergo a replacement of their knees are generally older adults who have dealt with severe knee pain and joint degeneration for a long time. The majority of them are sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and helps patients to live a better life. However, after the surgery, some patients have difficulty performing basic activities such as walking, or going up-down stairs, and the majority remains sedentary and gain weight. These combined problems leave patients at risk of worsening their health. Therefore, a treatment that takes care of all these combined problems is needed. We propose an all-inclusive treatment, called comprehensive behavioral intervention (CBI) that intends to improve the long-term effects of exercise programs. The CBI combines exercise program with promotion of physical activity, orientation on healthy nutrition, and an education approach that promotes self-initiative towards healthy habits. The overall aim of this proposed study is to test how patients post TKA will like the CBI program, how safe the program is, and adapt the program as needed for better acceptability. We believe the CBI will be safe, well tolerated, and will improve the ability of patients to perform physical tasks. We also believe the program will increase the amount of physical activity, will promote maintenance of healthy weight, and will help the patients to obtain and maintain healthy habits. In this study subjects will be selected by a flip of a coin to receive either our CBI program or a more traditional exercise program. Subjects will be tested before and after the treatments. Our measures of main interest are how well subjects move around and how physically active they are. We are also interested on the effect of the interventions on body weight, blood pressure, eating habits, and general health. The team of researchers for this study includes several disciplines. The proposed study will defend the need for a
Interventions
- BEHAVIORAL Comprehensive Behavioral Intervention
- OTHER Standard of Care Exercise Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01799772
The ClinicalTrials.gov registry entry for NCT01799772 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Comprehensive Behavioral Intervention is the first listed.
NCT01799772 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01799772 about?
NCT01799772 is a clinical study titled "The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA". Patients who undergo a replacement of their knees are generally older adults who have dealt with severe knee pain and joint degeneration for a long time. The majority of them are sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and helps patients to live a better...
What is the current status of trial NCT01799772?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-09. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01799772?
The interventions under investigation include: Comprehensive Behavioral Intervention (BEHAVIORAL), Standard of Care Exercise Program (OTHER).
Who is sponsoring clinical trial NCT01799772?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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