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Completed

NCT Number: NCT01537328

Progressive Rehabilitation Following Total Knee Arthroplasty

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Acronym: PROG

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Feb 23, 2012
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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