Clinical Efficacy of IoMT-based Exercise Program for the Elderly

Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Back Pain; Knee Osteoarthritis
• Intervention / Treatment: Other: Home based exercise program via a smartphone application

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeongyi Kwon, M.D,PhD; Phone Number: +82-2-3410-2818; Email: jeongyi.kwon@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based exercise program; 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).	Other: Home based exercise program via a smartphone application; Daily home based exercise program (30min/day, 7days/week for 6 weeks).
No Intervention: Exercise brochure; This group will be offered a brochure including number of exercises for back or knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis	Knee osteoarthritis functional index (Range: 0-96)	baseline
Western Ontario and McMaster Universities Osteoarthritis	Knee osteoarthritis functional index (Range: 0-96)	after 6weeks
Oswestry Disability Index	Low back pain functional index (Range: 0-100)	baseline
Oswestry Disability Index	Low back pain functional index (Range: 0-100)	after 6weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale	Pain score, The higher score means the worse pain (Range: 0-10)	baseline
Numeric rating scale	Pain score, The higher score means the worse pain (Range: 0-10)	after 6weeks
36-Item Short-Form Health Survey	Qualify of life, The higher score means the better condition (Range: 0-100)	baseline
36-Item Short-Form Health Survey	Qualify of life, The higher score means the better condition (Range: 0-100)	after 6weeks
Geriatric Depression Scale	Depression score, The higher score means the worse condition (Range: 0-15)	baseline
Geriatric Depression Scale	Depression score, The higher score means the worse condition (Range: 0-10)	after 6weeks
Timed-Up and Go test	Dynamic balance, The higher score means the worse balance.	baseline
Timed-Up and Go test	Dynamic balance, The higher score means the worse balance.	after 6weeks
30s chair sit and stand	Balance, The higher score means the better condition.	baseline
30s chair sit and stand	Balance, The higher score means the better condition.	after 6weeks

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Back Pain; Low Back Pain; Osteoarthritis, Knee
• Other Study ID Numbers: 2021-04-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No