Clinical Efficacy of IoMT-based Exercise Program for the Elderly

Samsung Medical Center

Status: Unknown

Conditions: Lower Back Pain; Knee Osteoarthritis

Treatments: Other: Home based exercise program via a smartphone application

Study type: Interventional

Funder types: Other

Identifiers

NCT05197010

2021-04-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Home-based exercise program

Experimental group

Description:

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).

Treatment:

Other: Home based exercise program via a smartphone application

Exercise brochure

No Intervention group

Description:

This group will be offered a brochure including number of exercises for back or knee.