Clinical Efficacy of IoMT-based Exercise Program for the Elderly
- Conditions
- Lower Back PainKnee Osteoarthritis
- Interventions
- Other: Home based exercise program via a smartphone application
- Registration Number
- NCT05197010
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- History of knee surgery
- Systemic inflammatary disease
- History of polyneuropathy
- History of stroke
- Severe heart failure
- Chronic obstructive pulmonary disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-based exercise program Home based exercise program via a smartphone application 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).
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Osteoarthritis after 6weeks Knee osteoarthritis functional index (Range: 0-96)
Oswestry Disability Index after 6weeks Low back pain functional index (Range: 0-100)
- Secondary Outcome Measures
Name Time Method Geriatric Depression Scale after 6weeks Depression score, The higher score means the worse condition (Range: 0-10)
36-Item Short-Form Health Survey after 6weeks Qualify of life, The higher score means the better condition (Range: 0-100)
Timed-Up and Go test after 6weeks Dynamic balance, The higher score means the worse balance.
Numeric rating scale after 6weeks Pain score, The higher score means the worse pain (Range: 0-10)
30s chair sit and stand after 6weeks Balance, The higher score means the better condition.
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of