Knee Osteoarthritis, Lower Back Pain
Conditions
Brief summary
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
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.
Interventions
OTHERHome based exercise program via a smartphone application
Daily home based exercise program (30min/day, 7days/week for 6 weeks).
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Prospective, single-center, single-blinded, two-armed randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis | baseline | Knee osteoarthritis functional index (Range: 0-96) |
| Oswestry Disability Index | baseline | Low back pain functional index (Range: 0-100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geriatric Depression Scale | baseline | Depression score, The higher score means the worse condition (Range: 0-15) |
| Numeric rating scale | baseline | Pain score, The higher score means the worse pain (Range: 0-10) |
| 30s chair sit and stand | baseline | Balance, The higher score means the better condition. |
| Timed-Up and Go test | baseline | Dynamic balance, The higher score means the worse balance. |
| 36-Item Short-Form Health Survey | baseline | Qualify of life, The higher score means the better condition (Range: 0-100) |
Countries
South Korea
Contacts
Primary ContactJeongyi Kwon, M.D,PhD
Outcome results
None listed