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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Daily home based exercise program (30min/day, 7days/week for 6 weeks).
Samsung Medical Center
Seoul, South Korea
RECRUITINGWestern Ontario and McMaster Universities Osteoarthritis
Knee osteoarthritis functional index (Range: 0-96)
Time frame: baseline
Western Ontario and McMaster Universities Osteoarthritis
Knee osteoarthritis functional index (Range: 0-96)
Time frame: after 6weeks
Oswestry Disability Index
Low back pain functional index (Range: 0-100)
Time frame: baseline
Oswestry Disability Index
Low back pain functional index (Range: 0-100)
Time frame: after 6weeks
Numeric rating scale
Pain score, The higher score means the worse pain (Range: 0-10)
Time frame: baseline
Numeric rating scale
Pain score, The higher score means the worse pain (Range: 0-10)
Time frame: after 6weeks
36-Item Short-Form Health Survey
Qualify of life, The higher score means the better condition (Range: 0-100)
Time frame: baseline
36-Item Short-Form Health Survey
Qualify of life, The higher score means the better condition (Range: 0-100)
Time frame: after 6weeks
Geriatric Depression Scale
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Depression score, The higher score means the worse condition (Range: 0-15)
Time frame: baseline
Geriatric Depression Scale
Depression score, The higher score means the worse condition (Range: 0-10)
Time frame: after 6weeks
Timed-Up and Go test
Dynamic balance, The higher score means the worse balance.
Time frame: baseline
Timed-Up and Go test
Dynamic balance, The higher score means the worse balance.
Time frame: after 6weeks
30s chair sit and stand
Balance, The higher score means the better condition.
Time frame: baseline
30s chair sit and stand
Balance, The higher score means the better condition.
Time frame: after 6weeks