Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jeongyi Kwon, M.D,PhD
- Numéro de téléphone: +82-2-3410-2818
- E-mail: jeongyi.kwon@samsung.com
Lieux d'étude
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Seoul, Corée, République de, 06351
- Recrutement
- Samsung Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Exercise brochure
This group will be offered a brochure including number of exercises for back or knee.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis
Délai: baseline
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Knee osteoarthritis functional index (Range: 0-96)
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baseline
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Western Ontario and McMaster Universities Osteoarthritis
Délai: 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
Délai: 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
Délai: after 6weeks
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Low back pain functional index (Range: 0-100)
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after 6weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Numeric rating scale
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: after 6weeks
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Balance, The higher score means the better condition.
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after 6weeks
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021-04-004
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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