Progressive Rehabilitation Following Total Knee Arthroplasty (PROG)

This study is currently recruiting participants.
Verified March 2012 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: January 4, 2013
Last verified: March 2012
  Purpose

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.

Condition Intervention Phase
Osteoarthritis
Other: Total knee replacement rehabilitation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progressive Rehabilitation Following Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 162
Study Start Date: July 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537328

Contacts
Contact: Jennifer Stevens-Lapsley, MPT, PHD 303-724-9170 Jennifer.Stevens-Lapsley@ucdenver.edu
Contact: Michelle Reynolds, MA 303-724-9590 Michelle.Reynolds@ucdenver.edu

Locations
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer Stevens-Lapsley, MPT and PHD    303-724-9170    Jennifer.Stevens-Lapsley@ucdenver.edu   
Contact: Michelle Reynolds, BS and MS    303-724-9590    Michelle.Reynolds@ucdenver.edu   
Principal Investigator: Jennifer Stevens-Lapsley, MPT, PHD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jennifer Stevens-Lapsley, MPT, PHD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01537328     History of Changes
Other Study ID Numbers: 10-1188, R01HD065900
Study First Received: August 26, 2011
Last Updated: January 4, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Total knee arthroplasty
quadriceps
muscle
arthroplasty
joint diseases
musculoskeletal diseases

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 21, 2014