Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Internet of Medical Things (IoMT) based home exercise programs for the elderly with degenerative knee arthritis or chronic low back pain.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator responsible for randomization was independent from the assessors, assuring blindness to treatment allocation and randomization procedures. The blinded assessor performed the baseline and post-treatment assessments.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History of knee surgery
- •Systemic inflammatary disease
- •History of polyneuropathy
- •History of stroke
- •Severe heart failure
- •Chronic obstructive pulmonary disease
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis
时间窗: after 6weeks
Knee osteoarthritis functional index (Range: 0-96)
Oswestry Disability Index
时间窗: after 6weeks
Low back pain functional index (Range: 0-100)
次要结局
- Geriatric Depression Scale(after 6weeks)
- 36-Item Short-Form Health Survey(after 6weeks)
- Timed-Up and Go test(after 6weeks)
- Numeric rating scale(after 6weeks)
- 30s chair sit and stand(after 6weeks)
研究者
Jeong Yi Kwon
Professor
Samsung Medical Center