Progressive Rehabilitation Following Total Knee Arthroplasty (PROG)

October 9, 2018 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive Treatment
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
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.
Active Comparator: Traditional treatment
Traditional intervention represents the synthesis of previously published total knee arthroplasty rehabilitation programs.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Stair climbing test (SCT)
Time Frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Timed-up-and-go Test (TUG)
Time Frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
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)
Time Frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
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
Time Frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Isometric quadriceps and hamstrings 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
Time Frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
WOMAC and SF-12
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
Time Frame: pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months
Doublet interpolation for quadriceps activation.
pre operatively (average of two weeks before surgery), change from baseline at 1, 2, 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

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

Investigators

  • Principal Investigator: Jennifer Stevens-Lapsley, MPT, PHD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1188
  • R01HD065900 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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