Clinical Efficacy of IoMT-based Exercise Program for the Elderly

NCT ID: NCT05197010

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Lower Back Pain Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, single-center, single-blinded, two-armed randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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).

Group Type EXPERIMENTAL

Home based exercise program via a smartphone application

Intervention Type OTHER

Daily home based exercise program (30min/day, 7days/week for 6 weeks).

Exercise brochure

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home based exercise program via a smartphone application

Daily home based exercise program (30min/day, 7days/week for 6 weeks).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Yi Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeongyi Kwon, M.D,PhD

Role: CONTACT

+82-2-3410-2818

Facility Contacts

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JEONG-YI KWON, MD, PHD

Role: primary

+8210-4591-1039

Other Identifiers

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2021-04-004

Identifier Type: -

Identifier Source: org_study_id

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