PHYSICAL THERAPY & REHAB
Efficacy of a 12-month, monitored home exercise programme compared with normal care commencing 2 months after total knee arthroplasty: A randomized controlled trial
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by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(7):18 J Rehabil Med. 2014 Jan 30;46(2):166-72. doi: 10.2340/16501977-1242108 patients with diagnosed knee osteoarthritis (OA) who had underwent total knee arthroplasty (TKA) were randomized to undergo, beginning 2 months post-surgery, either a 12-month home-based exercise program, or usual care. The purpose of this study was to determine whether this long-term exercise regimen improved pain, disability, quality of life and function in these patients when compared to usual care. Upon the completion of the intervention, results indicated that the exercise and control groups displayed similar improvements in WOMAC scores (pain, stiffness and function), quality of life, knee extension strength, and range of motion. Moreover, patients in the exercise group exhibited significantly superior improvements in knee flexion strength and maximal walking speed.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実=0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
3/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか?
The optimal postoperative rehabilitation regimen following total knee arthroplasty (TKA) has not yet been conclusively determined. Previous studies suggest that functional physical therapy exercises may improve patient outcome at 3-4 months, however these benefits may no longer be significant at 1 year. Furthermore, the results from one study suggest that home-based rehabilitation may yield improved pain and disability compared to in-patient rehabilitation. Home-based interventions were proposed as a means to eliminate some of the disadvantages associated with in-patient rehabilitation, such as increased cost, the requirement for trained personnel, as well as the burden of transportation and time-commitment on behalf of the patients. The present study compared the effectiveness of a long-term home-based rehabilitation protocol with that of usual care in patients who had undergone TKA.
主な研究課題は何ですか?
Does a 12-month postoperative home-based exercise program improve pain, disability and quality of life in patients who have undergone total knee arthroplasty (TKA), when compared to usual care and assessed 14 months after surgery?
重要な知見は?
- At 14 months post-operation, WOMAC scores were significantly reduced in the exercise and control groups by -15 (95% CI -20 to -10) vs. -14 (95% CI -19 to -9) for pain, -25 (95% CI -32 to -18) vs. -17 (95% CI -24 to -9) for stiffness, and -18 (95% CI -24 to -12) vs. -13 (95% CI -19 to -8) for functional difficulty (p<0.001). These improvements were not significantly different between groups (p>0.05).
- Mean changes in the physical and mental components of the SF-36 were significant in both groups following the 12-month intervention (p<0.001); however, there were no between-group differences at any time point (p>0.05).
- Improvement in knee flexion strength was significantly better in the exercise group (4.4 [95% CI 3.1 to 5.7]) compared to the control group (2.4 [95% CI 1.3 to 3.4]) (p=0.009), improvement in knee extension strength was statistically similar between groups (Exercise group: 15.1 (95% CI 12.5 to 17.6); Control group: 13.4 (95% CI 10.1 to 16.1); p=0.50).
- Maximal walking speed improved significantly more in the exercise group (0.32 [95% CI 0.26 to 0.38]) compared to the control group (0.17 [95% CI 0.11 to 0.24]) (p<0.001).
- Passive extension deficit, active extension deficit, passive flexion and active flexion similarly improved from baseline to 12 months in both groups (p=0.72, p=0.45, p=0.86, and p=0.98, respectively).
- At 6 months, 72% of participants in the exercise group reported performing the training sessions 2x/week. At 12 months, the proportion of patients exercising at least once a week, the mean exercise frequency, and the amount of leisure-time physical activity were all similar between groups (p>0.05).
- 5 participants in the exercise group did not complete the exercise program, citing pain during exercise. An additional 5 participants in the exercise group did not complete the exercise program, citing satisfaction with painless knees, to the point where they were no longer motivated to complete exercise.
最も覚えておくべきことは?
At 12 months, although the exercise and control groups displayed similar improvements in WOMAC scores (pain, stiffness and function), quality of life (both the mental and physical components), knee extension strength, and range of motion, patients in the exercise group exhibited significantly superior improvements in knee flexion strength and maximal walking speed. Adherence to the exercise program at 6 months was relatively low at 72%, and significantly more patients in the control group sought additional advice regarding their knee exercises.
それが私の患者ケアにどのように影響するか?
In patients with knee osteoarthritis who had undergone a total knee arthroplasty (TKA), a 12-month home-based exercise program is well-tolerated and may provide some functional benefits; however, it does not improve pain, disability or quality of life, when compared to usual care. Future studies could focus on developing strategies to increase the adherence rate for home-based exercise programs. Furthermore, a cost-effective analysis for long-term home-based interventions following TKA is warranted.
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