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Clinical Efficacy of IoMT-based Exercise Program for the Elderly

Primary Purpose

Lower Back Pain, Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Home based exercise program via a smartphone application
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home-based exercise program

Exercise brochure

Arm 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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2021
Last Updated
January 4, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05197010
Brief Title
Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Official Title
Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-center, single-blinded, two-armed randomized controlled trial
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based exercise program
Arm Type
Experimental
Arm 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).
Arm Title
Exercise brochure
Arm Type
No Intervention
Arm Description
This group will be offered a brochure including number of exercises for back or knee.
Intervention Type
Other
Intervention Name(s)
Home based exercise program via a smartphone application
Intervention Description
Daily home based exercise program (30min/day, 7days/week for 6 weeks).
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis
Description
Knee osteoarthritis functional index (Range: 0-96)
Time Frame
baseline
Title
Western Ontario and McMaster Universities Osteoarthritis
Description
Knee osteoarthritis functional index (Range: 0-96)
Time Frame
after 6weeks
Title
Oswestry Disability Index
Description
Low back pain functional index (Range: 0-100)
Time Frame
baseline
Title
Oswestry Disability Index
Description
Low back pain functional index (Range: 0-100)
Time Frame
after 6weeks
Secondary Outcome Measure Information:
Title
Numeric rating scale
Description
Pain score, The higher score means the worse pain (Range: 0-10)
Time Frame
baseline
Title
Numeric rating scale
Description
Pain score, The higher score means the worse pain (Range: 0-10)
Time Frame
after 6weeks
Title
36-Item Short-Form Health Survey
Description
Qualify of life, The higher score means the better condition (Range: 0-100)
Time Frame
baseline
Title
36-Item Short-Form Health Survey
Description
Qualify of life, The higher score means the better condition (Range: 0-100)
Time Frame
after 6weeks
Title
Geriatric Depression Scale
Description
Depression score, The higher score means the worse condition (Range: 0-15)
Time Frame
baseline
Title
Geriatric Depression Scale
Description
Depression score, The higher score means the worse condition (Range: 0-10)
Time Frame
after 6weeks
Title
Timed-Up and Go test
Description
Dynamic balance, The higher score means the worse balance.
Time Frame
baseline
Title
Timed-Up and Go test
Description
Dynamic balance, The higher score means the worse balance.
Time Frame
after 6weeks
Title
30s chair sit and stand
Description
Balance, The higher score means the better condition.
Time Frame
baseline
Title
30s chair sit and stand
Description
Balance, The higher score means the better condition.
Time Frame
after 6weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeongyi Kwon, M.D,PhD
Phone
+82-2-3410-2818
Email
jeongyi.kwon@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD, PHD
Phone
+8210-4591-1039
Email
jeongyi.kwon@samsung.com
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Efficacy of IoMT-based Exercise Program for the Elderly

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