Clinical Efficacy of IoMT-based Exercise Program for the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders

Conditions
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Lower Back Pain, Knee Osteoarthritis

Intervention / Treatment
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* Other: Home based exercise program via a smartphone application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-center, single-blinded, two-armed randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based exercise program<br>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). | Other: Home based exercise program via a smartphone application<br>* Daily home based exercise program (30min/day, 7days/week for 6 weeks).<br>|
| No Intervention: Exercise brochure<br>This group will be offered a brochure including number of exercises for back or knee. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis | Knee osteoarthritis functional index (Range: 0-96) | baseline | 
| Western Ontario and McMaster Universities Osteoarthritis | Knee osteoarthritis functional index (Range: 0-96) | after 6weeks | 
| Oswestry Disability Index | Low back pain functional index (Range: 0-100) | baseline | 
| Oswestry Disability Index | Low back pain functional index (Range: 0-100) | after 6weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale | Pain score, The higher score means the worse pain (Range: 0-10) | baseline | 
| Numeric rating scale | Pain score, The higher score means the worse pain (Range: 0-10) | after 6weeks | 
| 36-Item Short-Form Health Survey | Qualify of life, The higher score means the better condition (Range: 0-100) | baseline | 
| 36-Item Short-Form Health Survey | Qualify of life, The higher score means the better condition (Range: 0-100) | after 6weeks | 
| Geriatric Depression Scale | Depression score, The higher score means the worse condition (Range: 0-15) | baseline | 
| Geriatric Depression Scale | Depression score, The higher score means the worse condition (Range: 0-10) | after 6weeks | 
| Timed-Up and Go test | Dynamic balance, The higher score means the worse balance. | baseline | 
| Timed-Up and Go test | Dynamic balance, The higher score means the worse balance. | after 6weeks | 
| 30s chair sit and stand | Balance, The higher score means the better condition. | baseline | 
| 30s chair sit and stand | Balance, The higher score means the better condition. | after 6weeks |