Clinical Efficacy of IoMT-based Exercise Program for the Elderly

Sponsor

Samsung Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05197010

Collaborator

(none)

Enrollment

Location

Arms

6.6

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Back Pain Knee Osteoarthritis	Other: Home based exercise program via a smartphone application	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, single-center, single-blinded, two-armed randomized controlled trialProspective, single-center, single-blinded, two-armed randomized controlled trial

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 13, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Yi Kwon, Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT05197010

Other Study ID Numbers:

2021-04-004

First Posted:

Jan 19, 2022

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis, Knee

Low Back Pain

Study Results

No Results Posted as of Jan 19, 2022