A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty
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| First Received Date ICMJE | February 26, 2012 | ||||
| Last Updated Date | March 1, 2012 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in Six Minute Walk Test (6MWT) at six weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01545986 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty | ||||
| Official Title ICMJE | A Comparative Analysis of High Velocity and Standard Low Velocity Exercise Training on Rehabilitation Outcomes Following Total Knee Arthroplasty | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis, Knee | ||||
| Intervention ICMJE | Behavioral: Exercise
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.
Other Name: Rehabilitation |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 38 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years to 89 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01545986 | ||||
| Other Study ID Numbers ICMJE | 09-04 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Marie A. Kardys Kelly, Helen Hays Hospital | ||||
| Study Sponsor ICMJE | Helen Hayes Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Helen Hayes Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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