Comparison of Treatments Following Total Knee Replacement

NCT02237911 | Completed Results DMC

• 2 other identifiers: PRO14080261CER-1310-06994
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve many of the substantial functional limitations and physical inactivity that existed for a long time prior to the surgery. Exercise is an intervention that could improve these long-term limitations. To promote these improvements, exercise should be implemented at later stage post TKR when patients can tolerate doses of exercise sufficiently high to promote substantial changes. To date, we just don't have enough good research to tell us which type of exercise works best for which patients and under which circumstances at later stage post TKR. This research study will provide evidence for recommended interventions during the later stage post TKR. The specific research questions are: (1) How do group exercise in the community and individual exercise in rehabilitation clinic compare with usual medical care on physical function and activity outcomes? (2) Who are the patients most likely to respond to each exercise intervention? (3) Are the approaches safe?

Conditions

Degeneration; Articular Cartilage, Knee; Rheumatoid Arthritis; Osteoarthritis, Knee

Keywords

total knee replacement; rehabilitation; exercise program; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).

  WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.

  Baseline, 3 and 6 months

Secondary Outcomes (1)

• Composite Score of Performed-based Tests of Physical Function.

  Baseline, 3 and 6 months

Other Outcomes (1)

• Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear).

  Baseline, 3 and 6 months

Study Arms (3)

Clinic-based outpatient exercise group

EXPERIMENTAL

Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.

Other: Clinic-based outpatient exercise group

Community-based exercise group

ACTIVE COMPARATOR

Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.

Other: Community-based exercise group

Wait-listed usual medical care

NO INTERVENTION

Wait-listed usual medical care - no intervention provided by study.

Interventions

Clinic-based outpatient exercise group OTHER

Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.

Clinic-based outpatient exercise group

Community-based exercise group OTHER

Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.

Community-based exercise group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral TKR 2 to 4 months prior
• Older than 60 years of age
• Experience functional limitation in daily activities (score in WOMAC-PF of at least 9 points)
• Speak sufficient English to understand study instructions
• Have medical clearance to participate in the study
• Are willing to be randomized to one of the 3 treatment arms

You may not qualify if:

• Have absolute or relative contraindications to exercise
• Have history of uncontrolled cardiovascular disease or hypertension
• Are unable to walk 50 meters without an assistive device
• Have history of muscular or neurological disorder that affect lower extremity function
• Regular participation in exercise
• Terminal illness
• Planning to have another joint replacement during the next 12 months
• Plan not to be around during the next 12 months

Sponsors & Collaborators

• University of Pittsburgh: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Department of Physical Therapy, University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (2)

• Piva SR, Schneider MJ, Moore CG, Catelani MB, Gil AB, Klatt BA, DiGioia AM, Almeida GJ, Khoja SS, Sowa G, Irrgang JJ. Effectiveness of Later-Stage Exercise Programs vs Usual Medical Care on Physical Function and Activity After Total Knee Replacement: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190018. doi: 10.1001/jamanetworkopen.2019.0018.

  PMID: 30794296 DERIVED

• Piva SR, Moore CG, Schneider M, Gil AB, Almeida GJ, Irrgang JJ. A randomized trial to compare exercise treatment methods for patients after total knee replacement: protocol paper. BMC Musculoskelet Disord. 2015 Oct 16;16:303. doi: 10.1186/s12891-015-0761-5.

  PMID: 26474988 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Osteoarthritis

Results Point of Contact

• Title: Dr. Sara Piva
• Organization: University of Pittsburgh

spiva@pitt.edu

(412) 383-6712

Study Officials

• Sara R Piva, PT, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: December 1, 2014
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: March 11, 2019
• Results First Posted: March 11, 2019

Record last verified: 2018-11

Locations

US (1)