The Difference Between Rehabilitation With or Without Strength Training After Total Knee Replacement (TKA)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 28, 2011 |
| Last Updated Date | September 25, 2012 |
| Start Date ICMJE | January 2011 |
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint) . ] [ Designated as safety issue: No ] The 6-minute walk test (6MWT) measures the maximal distance a participant is able to walk in 6 minutes between 2 cones placed 29 meters apart from each other. Further assessments: 1 month and 6 months. |
| Original Primary Outcome Measures ICMJE |
The difference in change of the number of meters of the 6-minute walk test from pre-surgery to 1, 2 and 6 months after surgery between the two rehabilitation programmes. [ Time Frame: pre-surgery (baseline), 1, 2 and 6 months after surgery ] [ Designated as safety issue: No ] The participants have to walk between two cones placed 30 meter apart from each other as fast as possible. Running is not allowed. The outcome measure is reporting a change from baseline(pre-surgery) in number of meters walked in 6 minutes at 1, 2 and 6 months after surgery. |
| Change History | Complete list of historical versions of study NCT01351831 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
The impact of rehabilitation on inflammatoric response [ Time Frame: pre-surgery (basline), per-surgery, 1 day post-surgery and 1, 2 and 6 months ] [ Designated as safety issue: No ] |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Difference Between Rehabilitation With or Without Strength Training After Total Knee Replacement |
| Official Title ICMJE | The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial |
| Brief Summary | Background and purpose: In the early phase after a total knee replacement (TKA), patients experience a decrease in leg muscle strength with up to about 80%. This considerable loss of muscle strength is related to reduced functional performance at this point in time. As the loss of muscle strength and functional performance is most pronounced early after TKA, rehabilitation including strength training initiated early after TKA seems a logical choice. However, tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain and slow recovery of knee joint range of motion, have typically precluded strength training early after TKA. Hypothesis: Our hypothesis is that the effect of early rehabilitation including strength training will be greater than rehabilitation without strength training. If the hypothesis is confirmed, strength training early after TKA could be implemented directly into clinical rehabilitation practice. Participants and methods: Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand and speak Danish, have given informed consent, will be included in this study.The study is a single-blinded randomized controlled study, where the participants receive supervised 1) rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components of the rehabilitation program (balance-, and mobility training etc.) are the same in both groups except the strength training exercises. Instead of the strength training exercises, the group without strength training spend more time on warm-up exercises, mobility- and balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed twice per week. The participants perform a test battery 4 times from before to 6 months after the TKA. The test battery assesses the participants' walking ability, leg strength, knee pain, knee joint swelling- and range of motion, and self-reported function and quality of life. Ethical issues: From a pilot study conducted in the beginning of 2010, the investigators found, that strength training initiated early after TKA seems feasible, and does not increase knee joint swelling and knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Condition ICMJE | Osteoarthritis, Knee |
| Intervention ICMJE |
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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 | Active, not recruiting |
| Estimated Enrollment ICMJE | 70 |
| Estimated Completion Date | August 2013 |
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Denmark |
| Administrative Information | |
| NCT Number ICMJE | NCT01351831 |
| Other Study ID Numbers ICMJE | H-3-2010-106 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Thomas Linding Jakobsen, Copenhagen University Hospital, Hvidovre |
| Study Sponsor ICMJE | Copenhagen University Hospital, Hvidovre |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Copenhagen University Hospital, Hvidovre |
| Verification Date | August 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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