Clinical trial NCT05197010: Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Official title: Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Back Pain
Knee Osteoarthritis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, single-blinded, two-armed randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis
timeFrame: baseline
measure: Western Ontario and McMaster Universities Osteoarthritis
timeFrame: after 6weeks
measure: Oswestry Disability Index
timeFrame: baseline
measure: Oswestry Disability Index
timeFrame: after 6weeks
Secondary outcomes:
measure: Numeric rating scale
timeFrame: baseline
measure: Numeric rating scale
timeFrame: after 6weeks
measure: 36-Item Short-Form Health Survey
timeFrame: baseline
measure: 36-Item Short-Form Health Survey
timeFrame: after 6weeks
measure: Geriatric Depression Scale
timeFrame: baseline
measure: Geriatric Depression Scale
timeFrame: after 6weeks
measure: Timed-Up and Go test
timeFrame: baseline
measure: Timed-Up and Go test
timeFrame: after 6weeks
measure: 30s chair sit and stand
timeFrame: baseline
measure: 30s chair sit and stand
timeFrame: after 6weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: