Clinical Efficacy of IoMT-based Exercise Program for the Elderly

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197010
• Other study ID #: 2021-04-004
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: May 2022

Study information

• Verified date: January 2022
• Source: Samsung Medical Center
• Contact: Jeongyi Kwon, M.D,PhD
• Phone: +82-2-3410-2818
• Email: jeongyi.kwon[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Low Back Pain
• Lower Back Pain
• Osteoarthritis, Knee

Intervention

Other:
• Home based exercise program via a smartphone application
Daily home based exercise program (30min/day, 7days/week for 6 weeks).

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis	Knee osteoarthritis functional index (Range: 0-96)	baseline
Primary	Western Ontario and McMaster Universities Osteoarthritis	Knee osteoarthritis functional index (Range: 0-96)	after 6weeks
Primary	Oswestry Disability Index	Low back pain functional index (Range: 0-100)	baseline
Primary	Oswestry Disability Index	Low back pain functional index (Range: 0-100)	after 6weeks
Secondary	Numeric rating scale	Pain score, The higher score means the worse pain (Range: 0-10)	baseline
Secondary	Numeric rating scale	Pain score, The higher score means the worse pain (Range: 0-10)	after 6weeks
Secondary	36-Item Short-Form Health Survey	Qualify of life, The higher score means the better condition (Range: 0-100)	baseline
Secondary	36-Item Short-Form Health Survey	Qualify of life, The higher score means the better condition (Range: 0-100)	after 6weeks
Secondary	Geriatric Depression Scale	Depression score, The higher score means the worse condition (Range: 0-15)	baseline
Secondary	Geriatric Depression Scale	Depression score, The higher score means the worse condition (Range: 0-10)	after 6weeks
Secondary	Timed-Up and Go test	Dynamic balance, The higher score means the worse balance.	baseline
Secondary	Timed-Up and Go test	Dynamic balance, The higher score means the worse balance.	after 6weeks
Secondary	30s chair sit and stand	Balance, The higher score means the better condition.	baseline
Secondary	30s chair sit and stand	Balance, The higher score means the better condition.	after 6weeks