手腕损伤强化锻炼(WISE)与常规护理建议对改善疼痛和功能的对比 (WISE-DK)
丹麦50岁及以上成人桡骨远端骨折后改善疼痛和功能的渐进性抗阻与柔韧性锻炼对比常规护理建议:WISE-DK随机试验
The goal of this clinical trial is to find out whether a therapist-guided exercise program helps people aged 50 and older recover better, in terms of pain and function, after a wrist fracture, compared to the usual care advice they would normally receive. The main question it aims to answer is:
• Will participants who receive a therapist-supervised exercise program have better improvement in pain and function, as measured by the Patient Rated Wrist Evaluation questionnaire, six months after their injury?
Researchers will compare these participants with those who receive usual care, which includes advice on self-management, to see if the supervised exercise program leads to greater recovery.
Participants will:
- Either receive supervised exercise, with a therapy session of up to 60 minutes and two additional sessions of up to 30 minutes each in addition to usual-care, or they will receive solely usual-care, consisting of advice on self-management.
- Complete questionnaires electronically at baseline, 3-months, and 6-months.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Inger Mechlenburg, DMSc
- 电话号码:+45 21679062
- 邮箱:inger.mechlenburg@clin.au.dk
研究联系人备份
- 姓名:Andreas Bentzen, MHSc
- 电话号码:+45 53109112
- 邮箱:andreas.bentzen@clin.au.dk
学习地点
-
-
-
Aarhus N、丹麦、8200
- 招聘中
- Aarhus University Hospital
-
接触:
- Inger Mechlenburg, DMSc
- 电话号码:+45 21679062
- 邮箱:inger.mechlenburg@clin.au.dk
-
接触:
- Andreas Bentzen, MSc
- 电话号码:+45 53109112
- 邮箱:andreas.bentzen@clin.au.dk
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Distal radius fracture treated surgically or non-surgically
- Willing and able to give informed consent
Exclusion Criteria:
- Injury is more than two months old
- There is evidence that the patient would be unable to participate in therapy or a self-guided exercise program provided by a participating center or adhere to study procedures (including cognitive impairment and fracture/surgery complications such as Complex Regional Pain Syndrome)
- No e-mail address to receive electronic questionnaires
- Open fractures with a Gustilo & Anderson grading >1
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:日常护理
|
Verbal advice and a leaflet provided at the hospital. Advice will include hand and wrist mobilization exercises to restore flexibility and guidance on building up activity gradually. Participants receiving solely usual care will not be provided with access to the intervention materials (the Supervised Exercise workbook). |
|
实验性的:在常规护理基础上增加监督运动(干预)
|
Verbal advice, a leaflet, and instruction in a strength training program delivered by an occupational or physical therapist at the hospital or virtually. This is followed by two additional sessions with a therapist in the municipality, focusing on progression in the exercise program. Participants will receive written instructions (a Supervised Exercise workbook) along with a personal login to access a patient information video. The exercise program is a highly structured system of hand and upper limb exercises. The program will enable participants to progress their exercises after the initial set-up session with the therapist. The program will utilize a range of resistance exercises based upon functional movements designed to promote recovery of the strength required for activities of daily living (e.g., chopping, lifting, pushing, jar opening). Verbal advice and a leaflet provided at the hospital. Advice will include hand and wrist mobilization exercises to restore flexibility and guidance on building up activity gradually. Participants receiving solely usual care will not be provided with access to the intervention materials (the Supervised Exercise workbook). |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-Rated Wrist Evaluation (PRWE)
大体时间:Measured at baseline, 3 months and 6 months follow-up
|
The primary outcome is the Patient Rated Wrist Evaluation (PRWE) at 6 months post-randomization: A 15 item patient-reported questionnaire that assesses pain and functional difficulties in activities of daily living resulting from injuries affecting wrist joint area (total score ranges from 0 to 100, higher scores indicate worse wrist pain and function). The pain subscale has 5 items (0 = no pain, 10 = worst pain) and the function subscale has 10 items (0 = no difficulty, 10 = unable to do). A total score on a scale of 100 is computed from the two subscales equally weighted (0 = no disability). The total score is the trial primary outcome, with the two subscales also reported as secondary outcomes. |
Measured at baseline, 3 months and 6 months follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wrist pain subscale measured using the Patient Rated Wrist Evaluation (PRWE)
大体时间:Baseline, 3 months and 6 months follow-up
|
The PRWE pain subscale contains 5 items each of which is further rated from 0-10 (0 = no pain, 10 = worst pain). The maximum score in this section is 50 and minimum 0. |
Baseline, 3 months and 6 months follow-up
|
|
Wrist function subscale measured using the Patient Rated Wrist Evaluation (PRWE)
大体时间:Baseline, 3 months and 6 months follow-up
|
The PRWE function subscale contains 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items) and is rated from 0-10 (0 = no difficulty, 10 = unable to do). The score of all 10 items is summed and then divided by 2, resulting in a maximum score of 50 and minimum 0. |
Baseline, 3 months and 6 months follow-up
|
|
PROMIS Physical Function Upper Extremity-Short Form 7a
大体时间:Baseline, 3 months and 6 months follow-up
|
Self-reported capability focusing on activities that require use of the upper extremity including shoulder, arm, and hand activities. The PROMIS Physical Function Upper Extremity-Short Form 7a contains 7 questions scored 1-5, with 1 being unable to do the activity and 5 being able to do the activity without any difficulty. |
Baseline, 3 months and 6 months follow-up
|
|
QuickDASH
大体时间:Baseline, 3 months and 6 months follow-up
|
The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). A higher score indicates greater disability. |
Baseline, 3 months and 6 months follow-up
|
|
EuroQol 5 Dimensions (EQ-5D-5L)
大体时间:Baseline, 3 months and 6 months follow-up
|
Quality of life measured using the EuroQol 5 Dimensions (EQ-5D-5L) a validated, generalized and standardized instrument comprising a Visual Analogue Scale (VAS) measuring self-rated health and a health status instrument, consisting of a five-level response (no problems, some problems, moderate problems, severe problems and unable) for five domains related to daily activities; (i) mobility, (ii) selfcare, (iii) usual activities, (iv) pain and discomfort and (v) anxiety and depression. Responses to the health status classification system are converted into an overall score using a published utility algorithm for the Danish population. The EQ-5D health status scale ranges from negative scores -0.594 [reflective of a patient's quality of life being worse than death], 0 [death], to 1 [perfect health]. A respondent's EQ-VAS gives self-rated health on a scale where the endpoints are labelled 'best imaginable health state' (100) and 'worst imaginable health state' (0). |
Baseline, 3 months and 6 months follow-up
|
|
Self-Efficacy for Exercise scale (SEE)
大体时间:Baseline, 3 months and 6 months follow-up
|
A 9-item participant-reported questionnaire (total scores range from 0 to 90, higher scores indicate higher self-efficacy for exercise) will be used to assess the participants' confidence in their ability to exercise |
Baseline, 3 months and 6 months follow-up
|
|
Exercise adherence measured by self-reported exercise frequency
大体时间:3 months and 6 months follow-up
|
Participants will be asked to indicate how many times in the preceding week they have done specific exercises for their injured hand and upper extremity, to assess engagement with the advised exercises after wrist fracture. |
3 months and 6 months follow-up
|
|
Serious adverse events (SAEs)
大体时间:3 months and 6 months follow-up
|
All unexpected serious adverse events related to the randomized interventions will be recorded. These events will be reported by recruitment centers as they become aware of events. Serious adverse events are an adverse event that: results in death; is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapac-ity; is a congenital anomaly or birth defect; or is otherwise considered medically significant by the in-vestigator (i.e., medical events that may jeopardise the participant or may require an intervention to pre-vent one of the above characteristics/consequences). |
3 months and 6 months follow-up
|
|
Adverse events (AEs)
大体时间:3 months and 6 months follow-up
|
Foreseeable adverse events will be recorded as complications both by recruitment centers and participants. AEs that are unrelated to the intervention will not be reported. AEs deemed related to the intervention that do not meet the SAE definition and are not classed as foreseeable as per the following (such as discomfort during performance of exercises), will also not be reported. Foreseeable adverse events include: increase in pain lasting more than one week; treatment-related exacerbations of other medical conditions that do not meet the definition of serious (for example angina after exertion); development of Complex Regional Pain Syndrome; surgery to the injured wrist (unless an adverse event directly related to the exercise intervention, in which case this would be an SAE); development of carpal tunnel syndrome requiring medical intervention (corticosteroid injection or surgery); wound complication in the injured wrist. |
3 months and 6 months follow-up
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health resource use
大体时间:3 months and 6 months follow-up
|
Health resource use as measured by self-reported bespoke questionnaire (including primary and secondary care consultation, additional therapy, investigations, surgery, prescribed and over-the-counter pain medication), sick leave (days), out-of-pocket expenses. Resource use will be converted into costs using standard unit cost estimates. The components will be aggregated to estimate the total cost per participant. |
3 months and 6 months follow-up
|
合作者和调查者
调查人员
- 首席研究员:Inger Mechlenburg, DMSc、Aarhus University Hospital
- 学习椅:Jan D. Rölfing, MD.、Aarhus University Hospital
- 学习椅:Per H. Gundtoft, MD.、Aarhus University Hospital
- 学习椅:Andreas Bentzen, MHSc、Aarhus University Hospital
- 学习椅:David J. Keene, PhD、University of Oxford
- 学习椅:Matthew Costa, MD, PhD、University of Oxford
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- WISE-DK
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Anonymized patient-level data will be shared with collaborators in the UK to be combined in an individual participant data meta-analysis. Anonymized patient-level data will also be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
IPD 共享时间框架
Data will be available after publication of the trial
IPD 共享访问标准
Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.