Progressive Rehabilitation Following Total Knee Arthroplasty

NCT01537328 | Completed

• 2 other identifiers: 10-1188R01HD065900
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional rehabilitation program (TRAD). The investigators hypothesized:

• PROG will result in greater improvements in functional outcome measures such as: stair climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM).
• PROG will result in greater improvements in quadriceps muscle strength gains after TKA compared to TRAD.
• PROG will result in greater improvements in muscle mass and central activation compared to TRAD.

Conditions

Osteoarthritis

Keywords

Total knee arthroplasty; quadriceps; muscle; arthroplasty; joint diseases; musculoskeletal diseases

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Stair climbing test (SCT)

  Time to ascend and descend one flight of stairs

  pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months

Secondary Outcomes (5)

• Change from baseline in Timed-up-and-go Test (TUG)

  pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months

• Change from baseline in 6-minute walk test (6MW)

  pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months

• Change from baseline in muscle strength

  pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months

• Change from baseline in self-reported health status

  pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months

• Change from baseline in muscle activation

  pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months

Study Arms (2)

Progressive Treatment

EXPERIMENTAL

Progressive intervention will involve the early initiation of intensive rehabilitation using progressive exercise and faster progression to functional strengthening exercises.

Other: Total knee replacement rehabilitation

Traditional treatment

ACTIVE COMPARATOR

Traditional intervention represents the synthesis of previously published total knee arthroplasty rehabilitation programs.

Other: Total knee replacement rehabilitation

Interventions

Total knee replacement rehabilitation OTHER

After total knee arthroplasty, patients will be assigned to an outpatient rehabilitation clinic, based upon geography. Patients will be enrolled randomly into one of two rehabilitation programs (PROG or TRAD). Both rehabilitation programs will take place over 12 weeks. Both groups will receive treatment for range of motion, activities of daily living and gait training, as well as a home exercise program.

Progressive Treatment; Traditional treatment

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing a primary, unilateral knee arthroplasty
• body mass index \< 40 kg/m2

You may not qualify if:

• severe contralateral leg OA (\< 5/10 pain with stair climbing) or other unstable orthopaedic conditions that limit function
• neurological conditions that affect muscle function
• vascular or cardiac problems that limit function
• uncontrolled diabetes
• pregnancy

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Bade M, Struessel T, Paxton R, Winters J, Baym C, Stevens-Lapsley J. Performance on a Clinical Quadriceps Activation Battery Is Related to a Laboratory Measure of Activation and Recovery After Total Knee Arthroplasty. Arch Phys Med Rehabil. 2018 Jan;99(1):99-106. doi: 10.1016/j.apmr.2017.07.013. Epub 2017 Aug 31.

  PMID: 28864244 DERIVED

• Bade MJ, Struessel T, Dayton M, Foran J, Kim RH, Miner T, Wolfe P, Kohrt WM, Dennis D, Stevens-Lapsley JE. Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1360-1368. doi: 10.1002/acr.23139. Epub 2017 Aug 13.

  PMID: 27813347 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthritis; Rheumatic Diseases

Study Officials

• Jennifer Stevens-Lapsley, MPT, PHD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: February 23, 2012
• Study Start: July 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

US (1)