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Progressive Rehabilitation Following Total Knee Arthroplasty (PROG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Colorado, Denver
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01537328
First received: August 26, 2011
Last updated: October 30, 2014
Last verified: October 2014

August 26, 2011
October 30, 2014
July 2011
May 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Time to ascend and descend one flight of stairs
Change from baseline in Stair climbing test (SCT) [ Time Frame: pre operatively (average of two weeks before surgery), post operatively at 1, 2, 3 (primary endpoint), 6 and 12 months ] [ Designated as safety issue: No ]
Time to ascend and descend one flight of stairs
Complete list of historical versions of study NCT01537328 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Isometric quadriceps and hamstrings strength.
  • 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 ] [ Designated as safety issue: No ]
    WOMAC and SF-12
  • 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 ] [ Designated as safety issue: No ]
    Doublet interpolation for quadriceps activation.
  • Change from baseline in Timed-up-and-go Test (TUG) [ Time Frame: pre-operatively (average of two weeks before surgery), post-operatively at 1, 2, 3 (primary endpoint), 6, and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in 6 minute walk test (6MW) [ Time Frame: pre-operatively (average of two weeks before surgery), post-operatively at 1, 2, 3 (primary endpoint), 6, and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in muscle strength [ Time Frame: pre-operatively (average of two weeks before surgery), post-operatively at 1, 2, 3 (primary endpoint), 6, and 12 months ] [ Designated as safety issue: No ]
    Isometric quadriceps and hamstrings strength.
  • Change from baseline in self-reported health status [ Time Frame: pre-operatively (average of two weeks before surgery), post-operatively at 1, 2, 3 (primary endpoint), 6, and 12 months ] [ Designated as safety issue: No ]
    WOMAC and SF-12
  • Change from baseline in muscle activation [ Time Frame: preoperatively (average of two weeks before surgery), 1, 2, 3 (primary outcome), 6 and 12 months post-operatively ] [ Designated as safety issue: No ]
    Doublet interpolation for quadriceps activation.
Not Provided
Not Provided
 
Progressive Rehabilitation Following Total Knee Arthroplasty
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
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.
  • Experimental: Progressive Treatment
    Progressive intervention will involve the early initiation of intensive rehabilitation using progressive exercise and faster progression to functional strengthening exercises.
    Intervention: Other: Total knee replacement rehabilitation
  • Active Comparator: Traditional treatment
    Traditional intervention represents the synthesis of previously published total knee arthroplasty rehabilitation programs.
    Intervention: Other: Total knee replacement rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
162
May 2017
May 2016   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact: Jennifer Stevens-Lapsley, MPT, PHD 303-724-9170 Jennifer.Stevens-Lapsley@ucdenver.edu
Contact: Tawnya Downing, BS 303-724-9590 tawnya.downing@ucdenver.edu
United States
 
NCT01537328
10-1188, R01HD065900
No
University of Colorado, Denver
University of Colorado, Denver
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Jennifer Stevens-Lapsley, MPT, PHD University of Colorado, Denver
University of Colorado, Denver
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP