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The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799772
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh

Brief 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 larger study that can have a very important impact on the public health of patients post TKA. The reason for the public health impact is if the physical limitations experiences by patients post TKA are left untreated, they tend to get worse. Furthermore, by increasing physical activity and promoting healthy weight, it may improve general health and prevent chronic diseases. Last, developing educational intervention that promotes self-initiative will result in long-term health benefits post TKA.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Behavioral: Comprehensive Behavioral Intervention Other: Standard of Care Exercise Program Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Feasibility of a Comprehensive Behavioral Intervention in Patient Post Total Knee Arthroplasty
Study Start Date : September 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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.

Behavioral: Comprehensive Behavioral Intervention
  1. Evidence-based exercise program - Combination of high intensity lower extremity strengthening, endurance on the treadmill, functional task-oriented exercises, and balance techniques. During 12 sessions, subjects will be instructed to become independent in performing the exercises at home.
  2. Physical activity promotion - Instructions to engage in moderate intensity exercise 5 days/week will be delivered along with the exercise program.
  3. Healthy nutrition guidance - Instructions on healthy nutrition delivered by a dietitian.
  4. Self-management - Basic self-management skills advocated by the Arthritis Foundation Self-Help Program and behavioral strategies (self-monitoring, problem solving, relapse prevention, and goal-setting) and feedback into approaches a, b and c.

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.
Other: Standard of Care Exercise Program
Typical rehabilitation after TKA surgery




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from Baseline in Performance-based physical function [ Time Frame: 6 months ]
    Change from Baseline in Self-selected gait speed at 6 months.

  2. Change from Baseline in Performance-based Physical Function [ Time Frame: 6 months ]
    Change from Baseline in Timed 5 chair rise at 6 months.

  3. Change from Baseline in Performance-based Physical Function [ Time Frame: 6 months ]
    Change from Baseline in single leg balance time at 6 months.

  4. Change from Baseline in Performance-based Physical Function [ Time Frame: 6 months ]
    Change from Baseline in timed ascend/descend stair test at 6 months.

  5. Change from Baseline in Performance-based Physical Test [ Time Frame: 6 months ]
    Change from Baseline in 6 minutes walk test at 6 months.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01799772


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Sara R Piva, PT, PhD University of Pittsburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01799772    
Other Study ID Numbers: PRO11030404
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014