- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05197010
Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jeongyi Kwon, M.D,PhD
- Telefonnummer: +82-2-3410-2818
- E-mail: jeongyi.kwon@samsung.com
Studiesteder
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Seoul, Korea, Republikken, 06351
- Rekruttering
- Samsung Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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).
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Daily home based exercise program (30min/day, 7days/week for 6 weeks).
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Ingen indgriben: Exercise brochure
This group will be offered a brochure including number of exercises for back or knee.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Western Ontario and McMaster Universities Osteoarthritis
Tidsramme: baseline
|
Knee osteoarthritis functional index (Range: 0-96)
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baseline
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Western Ontario and McMaster Universities Osteoarthritis
Tidsramme: after 6weeks
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Knee osteoarthritis functional index (Range: 0-96)
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after 6weeks
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Oswestry Disability Index
Tidsramme: baseline
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Low back pain functional index (Range: 0-100)
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baseline
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Oswestry Disability Index
Tidsramme: after 6weeks
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Low back pain functional index (Range: 0-100)
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after 6weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Numeric rating scale
Tidsramme: baseline
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Pain score, The higher score means the worse pain (Range: 0-10)
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baseline
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Numeric rating scale
Tidsramme: after 6weeks
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Pain score, The higher score means the worse pain (Range: 0-10)
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after 6weeks
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36-Item Short-Form Health Survey
Tidsramme: baseline
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Qualify of life, The higher score means the better condition (Range: 0-100)
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baseline
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36-Item Short-Form Health Survey
Tidsramme: after 6weeks
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Qualify of life, The higher score means the better condition (Range: 0-100)
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after 6weeks
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Geriatric Depression Scale
Tidsramme: baseline
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Depression score, The higher score means the worse condition (Range: 0-15)
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baseline
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Geriatric Depression Scale
Tidsramme: after 6weeks
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Depression score, The higher score means the worse condition (Range: 0-10)
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after 6weeks
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Timed-Up and Go test
Tidsramme: baseline
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Dynamic balance, The higher score means the worse balance.
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baseline
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Timed-Up and Go test
Tidsramme: after 6weeks
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Dynamic balance, The higher score means the worse balance.
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after 6weeks
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30s chair sit and stand
Tidsramme: baseline
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Balance, The higher score means the better condition.
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baseline
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30s chair sit and stand
Tidsramme: after 6weeks
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Balance, The higher score means the better condition.
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after 6weeks
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021-04-004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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