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Completed

NCT Number: NCT01799772

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 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive Behavioral Intervention

Behavioral
  • 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.
  • Physical activity promotion - Instructions to engage in moderate intensity exercise 5 days/week will be delivered along with the exercise program.
  • Healthy nutrition guidance - Instructions on healthy nutrition delivered by a dietitian.
  • 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.

Standard of Care Exercise Program

Other

Typical rehabilitation after TKA surgery

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

The Feasibility of a Comprehensive Behavioral Intervention in Patient Post Total Knee Arthroplasty

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2013
Registry last updated
Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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