Progressive Rehabilitation Following Total Knee Arthroplasty

NCT ID: NCT01537328

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2018-06-30

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.

Detailed Description

Over 500,000 total knee arthroplasties (TKAs) are performed each year in the United States to alleviate pain and disability associated with knee osteoarthritis (OA), and this number is expected to grow to 3.48 million per year by the year 2030. TKA reduces pain and improves self-reported function compared to pre-operative levels, but post-operative deficits in walking speed (20% slower) and stair climbing speed (50% slower) can persist for years. Stair climbing performance is the single largest residual deficit after TKA with seventy-five percent of TKA patients reporting difficulty negotiating stairs after surgery. Collectively, these findings suggest that current rehabilitation does not adequately target the impairments that lead to long-term deficits in functional mobility after TKA.

The aim of the proposed trial is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after TKA compared to a traditional rehabilitation program (TRAD). The PROG intervention will involve intensive rehabilitation using progressive resistance exercise and faster progression to functional strengthening exercises. The TRAD intervention represents the synthesis of previously published TKA rehabilitation programs. Our preliminary data suggest that the PROG intervention has low risk and results in improved functional mobility and muscle strength. The investigators will measure function and strength at six time points (pre-op; 1, 2, 3, 6, and 12 months after TKA). The investigators will also evaluate the contribution of changes in muscle mass (atrophy/hypertrophy) and central activation to changes in muscle strength following PROG and TRAD interventions.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Progressive Treatment

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

Group Type: EXPERIMENTAL

Total knee replacement rehabilitation

Intervention Type: 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.

Traditional treatment

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

Group Type: ACTIVE_COMPARATOR

Total knee replacement rehabilitation

Intervention Type: 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.

Interventions

Total knee replacement rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Stevens-Lapsley, MPT, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28864244 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27813347 (View on PubMed)

Other Identifiers

R01HD065900

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-1188

Identifier Type: -

Identifier Source: org_study_id