The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA

NCT01799772 | Completed Phase 1 DMC

• 1 other identifier: PRO11030404
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Self-reported physical function

  Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index - Physical Function scale (WOMAC-PF) at 6 months.

  6 months

Secondary Outcomes (5)

• Change from Baseline in Performance-based physical function

  6 months

• Change from Baseline in Performance-based Physical Function

  6 months

• Change from Baseline in Performance-based Physical Function

  6 months

• Change from Baseline in Performance-based Physical Function

  6 months

• Change from Baseline in Performance-based Physical Test

  6 months

Other Outcomes (3)

• Change from Baseline in measures of physical activity

  6 months

• Change from Baseline in measures of General Health Status

  6 months

• Change from Baseline in measures of physical activity

  6 months

Study Arms (2)

Comprehensive behavioral intervention

EXPERIMENTAL

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

Standard of Care Exercise Program (SCE)

ACTIVE COMPARATOR

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

Interventions

Comprehensive Behavioral Intervention BEHAVIORAL

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.

Comprehensive behavioral intervention

Standard of Care Exercise Program OTHER

Typical rehabilitation after TKA surgery

Standard of Care Exercise Program (SCE)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Piva SR, Almeida GJ, Gil AB, DiGioia AM, Helsel DL, Sowa GA. Effect of Comprehensive Behavioral and Exercise Intervention on Physical Function and Activity Participation After Total Knee Replacement: A Pilot Randomized Study. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1855-1862. doi: 10.1002/acr.23227. Epub 2017 Nov 2.

  PMID: 28217891 DERIVED

Study Officials

• Sara R Piva, PT, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 27, 2013
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

US (1)