Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
研究概览
详细说明
This study presents the protocol of a prospective, single-center, single-blinded, two-armed randomized controlled trial.
The investigators plan to recruit patients over 65 years of age with degenerative knee arthritis or chronic low back pain. Patients will be randomly divided into two groups with 1:1 allocation.
The intervention group will receive 6 weeks of the IoT-based home exercise program. The IoMT-based home exercise program is implemented to the patients via a smartphone application. The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise (Figure 1). The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
The activity detector records the amount of activity and the speed of movement within the home. The door sensor detects the enter and exit and records the number of outings. The pillbox notifies subjects to take the medication time. The smart-care phone provides emergency call and guardian connection services. The body composition analyzer measures body mass index, fat, and muscle mass.
The primary outcome in patients with degenerative knee arthritis is Western Ontario and McMaster Universities Osteoarthritis. And the primary outcome in patients with chronic low back pain is Oswestry Disability Index. The secondary outcomes are numeric rating scale for pain, 36-Item Short-Form Health Survey, Geriatric Depression Scale, Timed-Up and Go test, and 30s chair sit and stand.
The investigators evaluate primary and secondary outcomes before and after the home exercise programs.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jeongyi Kwon, M.D,PhD
- 电话号码：+82-2-3410-2818
- 邮箱：jeongyi.kwon@samsung.com
学习地点
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Seoul、大韩民国、06351
- 招聘中
- Samsung Medical Center
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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:
- Knee pain for more than 3months, Kellgren-Lawrence grade 2 or higher
- Low back pain for more than 3months
- A person who underdtands the exercise program
- Numeric rating scale of 4 or higher
Exclusion Criteria:
- History of knee surgery
- Systemic inflammatary disease
- History of polyneuropathy
- History of stroke
- Severe heart failure
- Chronic obstructive pulmonary disease
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Home-based exercise program
The subjects will receive 6 weeks of the home exercise program via a smartphone application.
The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise.
The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
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Daily home based exercise program (30min/day, 7days/week for 6 weeks).
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无干预：Exercise brochure
This group will be offered a brochure including number of exercises for back or knee.
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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 |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis
大体时间：baseline
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Knee osteoarthritis functional index (Range: 0-96)
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baseline
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Western Ontario and McMaster Universities Osteoarthritis
大体时间：after 6weeks
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Knee osteoarthritis functional index (Range: 0-96)
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after 6weeks
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Oswestry Disability Index
大体时间：baseline
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Low back pain functional index (Range: 0-100)
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baseline
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Oswestry Disability Index
大体时间：after 6weeks
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Low back pain functional index (Range: 0-100)
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after 6weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Numeric rating scale
大体时间：baseline
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Pain score, The higher score means the worse pain (Range: 0-10)
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baseline
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Numeric rating scale
大体时间：after 6weeks
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Pain score, The higher score means the worse pain (Range: 0-10)
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after 6weeks
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36-Item Short-Form Health Survey
大体时间：baseline
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Qualify of life, The higher score means the better condition (Range: 0-100)
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baseline
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36-Item Short-Form Health Survey
大体时间：after 6weeks
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Qualify of life, The higher score means the better condition (Range: 0-100)
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after 6weeks
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Geriatric Depression Scale
大体时间：baseline
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Depression score, The higher score means the worse condition (Range: 0-15)
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baseline
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Geriatric Depression Scale
大体时间：after 6weeks
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Depression score, The higher score means the worse condition (Range: 0-10)
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after 6weeks
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Timed-Up and Go test
大体时间：baseline
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Dynamic balance, The higher score means the worse balance.
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baseline
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Timed-Up and Go test
大体时间：after 6weeks
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Dynamic balance, The higher score means the worse balance.
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after 6weeks
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30s chair sit and stand
大体时间：baseline
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Balance, The higher score means the better condition.
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baseline
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30s chair sit and stand
大体时间：after 6weeks
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Balance, The higher score means the better condition.
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after 6weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
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腰痛的临床试验
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完全的