Lower Back PainNCT05197010
Clinical Efficacy of IoMT-based Exercise Program for the Elderly
A study testing Home based exercise program via a smartphone application in people with Lower Back Pain and Knee Osteoarthritis, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lower Back Pain, Knee Osteoarthritis
- What is being tested?
- Home based exercise program via a smartphone application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of knee surgery
- Systemic inflammatary disease
- History of polyneuropathy
- History of stroke
- Severe heart failure
- Chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
JEONG-YI KWON, MD, PHD, +8210-4591-1039, jeongyi.kwon@samsung.com
JEONG-YI KWON, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Back Pain, Knee Osteoarthritis
- Being tested
- Home based exercise program via a smartphone application
- Medical subject headings
- Low Back Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based exercise program via a smartphone applicationOther
Daily home based exercise program (30min/day, 7days/week for 6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Home-based exercise program | Experimental | 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). Receives: Other: Home based exercise program via a smartphone application |
| Exercise brochure | No intervention | This group will be offered a brochure including number of exercises for back or knee. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis
Knee osteoarthritis functional index (Range: 0-96)
Measured: baseline
Western Ontario and McMaster Universities Osteoarthritis
Knee osteoarthritis functional index (Range: 0-96)
Measured: after 6weeks
Oswestry Disability Index
Low back pain functional index (Range: 0-100)
Measured: baseline
Oswestry Disability Index
Low back pain functional index (Range: 0-100)
Measured: after 6weeks
Secondary outcomes (10)
Numeric rating scale
Pain score, The higher score means the worse pain (Range: 0-10)
Measured: baseline
Numeric rating scale
Pain score, The higher score means the worse pain (Range: 0-10)
Measured: after 6weeks
36-Item Short-Form Health Survey
Qualify of life, The higher score means the better condition (Range: 0-100)
Measured: baseline
36-Item Short-Form Health Survey
Qualify of life, The higher score means the better condition (Range: 0-100)
Measured: after 6weeks
Geriatric Depression Scale
Depression score, The higher score means the worse condition (Range: 0-15)
Measured: baseline
Geriatric Depression Scale
Depression score, The higher score means the worse condition (Range: 0-10)
Measured: after 6weeks
Timed-Up and Go test
Dynamic balance, The higher score means the worse balance.
Measured: baseline
Timed-Up and Go test
Dynamic balance, The higher score means the worse balance.
Measured: after 6weeks
30s chair sit and stand
Balance, The higher score means the better condition.
Measured: baseline
30s chair sit and stand
Balance, The higher score means the better condition.
Measured: after 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start13 Oct 2021
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, single-blinded, two-armed randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197010
- Sponsor's protocol ID
- 2021-04-004
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Im YJ, Choi J, Choi SA, Kwon JY, Do JG. Feasibility and Preliminary Effectiveness of a Mobile App-Based Personalized Exercise Program in Older Patients With Chronic Knee Osteoarthritis: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Dec 16;13:e71073. doi: 10.2196/71073.
PubMed 41401375
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT05197010
- Acronym / sponsor ID
- 2021-04-004
- Conditions
- Lower Back Pain, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-center, single-blinded, two-armed randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Home-based exercise program | Experimental | Other: Home based exercise program via a smartphone applicationThe 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). |
| Exercise brochure | No intervention | –This group will be offered a brochure including number of exercises for back or knee. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- History of knee surgery
- Systemic inflammatary disease
- History of polyneuropathy
- History of stroke
- Severe heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based exercise program via a smartphone applicationDaily home based exercise program (30min/day, 7days/week for 6 weeks). | Other | Home-based exercise program |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis
Time frame: baseline
Knee osteoarthritis functional index (Range: 0-96)
Western Ontario and McMaster Universities Osteoarthritis
Time frame: after 6weeks
Knee osteoarthritis functional index (Range: 0-96)
Oswestry Disability Index
Time frame: baseline
Low back pain functional index (Range: 0-100)
Oswestry Disability Index
Time frame: after 6weeks
Low back pain functional index (Range: 0-100)
10 secondary outcomes
Numeric rating scale
Time frame: baseline
Numeric rating scale
Time frame: after 6weeks
36-Item Short-Form Health Survey
Time frame: baseline
36-Item Short-Form Health Survey
Time frame: after 6weeks
Geriatric Depression Scale
Time frame: baseline
Geriatric Depression Scale
Time frame: after 6weeks
Timed-Up and Go test
Time frame: baseline
Timed-Up and Go test
Time frame: after 6weeks
30s chair sit and stand
Time frame: baseline
30s chair sit and stand
Time frame: after 6weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 41401375Im YJ, Choi J, Choi SA, Kwon JY, Do JG. Feasibility and Preliminary Effectiveness of a Mobile App-Based Personalized Exercise Program in Older Patients With Chronic Knee Osteoarthritis: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Dec 16;13:e71073. doi: 10.2196/71073.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based exercise program via a smartphone application in people with Lower Back Pain and Knee Osteoarthritis, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeongyi Kwon, M.D,PhD (+82-2-3410-2818, jeongyi.kwon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.