Back to resultsA Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Joint Replacement, Exercise, Power training
Eligibility Criteria
Inclusion Criteria:
- Adults aged 60- 89 years of age.
- primary unilateral TKA 10-21 days prior to the outpatient PT evaluation
- received inpatient rehabilitation at Helen Hayes Hospital
Exclusion Criteria:
- Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing
- any other lower extremity joint replacement surgery
- diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes
- chest pain or shortness of breath on stair-climbing
- requirement of human assistance to walk in addition to the ambulation device
- inability to follow instructions to perform testing and/or exercise,
- participants who stated that they would not be available to complete 12 exercise sessions
- individual adherence with performance of a home exercise program (HEP) less than five of seven days at the end of the treatment period
Sites / Locations
- Helen Hayes Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Velocity Exercise
Low Velocity exercise
Arm Description
The high velocity exercise group performed the concentric contraction phase of resisted exercise in one second or less. This group performed sit to stand exercise, walking, curbs, and stairs as fast as was comfortable without an increased limp. Other exercises were performed at the participant preferred rate.
The low velocity exercise group performed the concentric contraction phase of resisted exercise in two seconds. This group performed sit to stand exercise, walking, curbs, stairs, and other exercises at the participant preferred rate.
Outcomes
Primary Outcome Measures
Change from Baseline in Six Minute Walk Test (6MWT) at six weeks
The distance walked in six minutes is measured for the 6MWT. A 150 foot hallway is used for the test. Standardized instructions are read to the participant. The participant is asked to walk as fast as he/she feels comfortable and safe in order to walk far as he/she can during six minutes. Distance is recorded in feet and later is converted to meters.
Secondary Outcome Measures
Gait Abnormality Rating Scale (GARS)
The GARS is a rating of gait quality. The participant is videotaped walking 10 meters from front, back, left, and right views. No type of walking aid is allowed. Standardized instructions are read to the participant including that he/she should walk at his/her usual speed. At a later time the videotape is viewed to rate gait on a four point (0-3) Likert type scale. Zero is gait without deviations and 48 is greatest amount of gait deviations.
Change from Baseline in Visual Analogue Scale (VAS) Pain at six weeks
The VAS Pain is a 10 cm horizontal line with the words "severe moderate slight" spread out along the whole length. The end points are labeled "Pain as bad as it could be" and "No pain". A pencil is given to the participant to mark his/her answer. Standardized instructions are read to the participant. The test is scored by a number from 0 to 100 as measured in mm along the line with zero being no pain and 100 being pain as bad as it could get.
Change from Baseline in Timed Up and Go Test (TUG) at six weeks
The TUG records the time in seconds needed to stand from sitting, walk 3 meters, return, and sit into the chair. A standard chair with armrests is used. Assistive devices are allowed but no physical assistance is given. Standardized instructions are read to the participant. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.
Gait Velocity
The participant walks while being videotaped. Standardized instructions are read to the participant when he/she is told that he/she should walk at his/her usual pace to the end of a 10 meter walkway. A side view is used. The videotape is viewed later for scoring. The acceleration and deceleration time is excluded by recording only the time taken to walk across the central 4 meters. This time and the 4 meter distance are used to calculate velocity in meters per second.
Change from Baseline in Short Form-36 (SF-36) at six weeks
The Short Form-36 (SF-36) is a 36 item paper questionnaire which measures general health. Standarized instructions read to the participant prior to him/her filling it out. Scores range from 0-100, with 100 being highest level of physical and mental health.
Change from Baseline in Stair Climb Test at six weeks
The time used to climb a flight of 12 steps and descend is recorded. Standardized instructions are read to the participant. Time is recorded in seconds. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01545986
Brief Title
A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty
Official Title
A Comparative Analysis of High Velocity and Standard Low Velocity Exercise Training on Rehabilitation Outcomes Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helen Hayes Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to compare the effects of two exercise programs, using low velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals performing HV exercise, compared to LV, would exhibit superior outcomes.
Detailed Description
The most effective type of exercise has not been identified for individuals who undergo total knee arthroplasty (TKA). High velocity (HV) exercise when compared to low velocity (LV) exercise produces greater gains in power and certain functional activities in older adults. The use of HV exercise for patients who undergo TKA has not been investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Joint Replacement, Exercise, Power training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Velocity Exercise
Arm Type
Experimental
Arm Description
The high velocity exercise group performed the concentric contraction phase of resisted exercise in one second or less. This group performed sit to stand exercise, walking, curbs, and stairs as fast as was comfortable without an increased limp. Other exercises were performed at the participant preferred rate.
Arm Title
Low Velocity exercise
Arm Type
Active Comparator
Arm Description
The low velocity exercise group performed the concentric contraction phase of resisted exercise in two seconds. This group performed sit to stand exercise, walking, curbs, stairs, and other exercises at the participant preferred rate.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Rehabilitation
Intervention Description
Participants attended standardized exercise (ex) sessions twice a week for six weeks for 12 sessions. Group speed differed for concentric contractions, sit to stand ex, walking, curbs, and stairs. The low velocity ex group performed a concentric contraction in two seconds, and high velocity group in one second or less. End range concentric hold, eccentric contraction, repetition (rep) rest and set rest were the same. Open chain ex was performed at 50% of one Repetition Maximum (RM) x 10 reps x one set and then 80% of 1RM x 10 reps x two sets. Curb height and 1RM was assessed at the first, fifth and ninth sessions. Manual stretching, balance ex, sit to stand support, level of aerobic ex, gait training, and functional training were assessed and progressed at any session.
Primary Outcome Measure Information:
Title
Change from Baseline in Six Minute Walk Test (6MWT) at six weeks
Description
The distance walked in six minutes is measured for the 6MWT. A 150 foot hallway is used for the test. Standardized instructions are read to the participant. The participant is asked to walk as fast as he/she feels comfortable and safe in order to walk far as he/she can during six minutes. Distance is recorded in feet and later is converted to meters.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Gait Abnormality Rating Scale (GARS)
Description
The GARS is a rating of gait quality. The participant is videotaped walking 10 meters from front, back, left, and right views. No type of walking aid is allowed. Standardized instructions are read to the participant including that he/she should walk at his/her usual speed. At a later time the videotape is viewed to rate gait on a four point (0-3) Likert type scale. Zero is gait without deviations and 48 is greatest amount of gait deviations.
Time Frame
6 weeks
Title
Change from Baseline in Visual Analogue Scale (VAS) Pain at six weeks
Description
The VAS Pain is a 10 cm horizontal line with the words "severe moderate slight" spread out along the whole length. The end points are labeled "Pain as bad as it could be" and "No pain". A pencil is given to the participant to mark his/her answer. Standardized instructions are read to the participant. The test is scored by a number from 0 to 100 as measured in mm along the line with zero being no pain and 100 being pain as bad as it could get.
Time Frame
6 weeks
Title
Change from Baseline in Timed Up and Go Test (TUG) at six weeks
Description
The TUG records the time in seconds needed to stand from sitting, walk 3 meters, return, and sit into the chair. A standard chair with armrests is used. Assistive devices are allowed but no physical assistance is given. Standardized instructions are read to the participant. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.
Time Frame
6 weeks
Title
Gait Velocity
Description
The participant walks while being videotaped. Standardized instructions are read to the participant when he/she is told that he/she should walk at his/her usual pace to the end of a 10 meter walkway. A side view is used. The videotape is viewed later for scoring. The acceleration and deceleration time is excluded by recording only the time taken to walk across the central 4 meters. This time and the 4 meter distance are used to calculate velocity in meters per second.
Time Frame
6 weeks
Title
Change from Baseline in Short Form-36 (SF-36) at six weeks
Description
The Short Form-36 (SF-36) is a 36 item paper questionnaire which measures general health. Standarized instructions read to the participant prior to him/her filling it out. Scores range from 0-100, with 100 being highest level of physical and mental health.
Time Frame
6 weeks
Title
Change from Baseline in Stair Climb Test at six weeks
Description
The time used to climb a flight of 12 steps and descend is recorded. Standardized instructions are read to the participant. Time is recorded in seconds. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged 60- 89 years of age.
primary unilateral TKA 10-21 days prior to the outpatient PT evaluation
received inpatient rehabilitation at Helen Hayes Hospital
Exclusion Criteria:
Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing
any other lower extremity joint replacement surgery
diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes
chest pain or shortness of breath on stair-climbing
requirement of human assistance to walk in addition to the ambulation device
inability to follow instructions to perform testing and/or exercise,
participants who stated that they would not be available to complete 12 exercise sessions
individual adherence with performance of a home exercise program (HEP) less than five of seven days at the end of the treatment period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie A. Kelly, DHS
Organizational Affiliation
Helen Hayes Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Hayes Hospital
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10993
Country
United States
12. IPD Sharing Statement
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A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty
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