- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07560098
Reablement Intervention for Older Adults in Day Care Centers
Reablement Intervention for Older Adults With Functional Decline in Day Care Centers: An Exploratory Quasi-Experimental Study Comparing Exercise Intervention
This study explores the effectiveness of reablement interventions for older adults with declining mobility in adult day care centers and compares them with traditional exercise interventions. In recent years, reablement has gained increasing attention. It is a person-centered approach that emphasizes goal-oriented training through activities of daily living, combined with interdisciplinary collaboration, to enhance individuals' self-care abilities and participation in daily life. In contrast, exercise interventions are typically structured programs focusing on improving muscle strength, balance, and endurance. While both approaches aim to enhance physical function, they differ in philosophy, implementation context, and motivational mechanisms. Reablement emphasizes meaningful, individualized, and context-based activities, which may enhance motivation and adherence, whereas exercise interventions are more standardized and efficient but may lack relevance to daily life, potentially affecting long-term engagement.
This study adopts a quasi-experimental design to compare the effects of reablement and exercise interventions on mobility, fear of falling, activities of daily living, and subjective well-being among older adults. It also evaluates the feasibility of implementing reablement in day care centers. Additionally, participants' preferences, attendance, and engagement in different intervention approaches are examined to address the current gap in comparative research.
Overall, the findings suggest that incorporating reablement into day care services-through individualized goal setting and interdisciplinary collaboration-can enhance functional performance, quality of life, and independence among older adults. The results also provide important evidence for future long-term care policy and practice, supporting a shift from a care-oriented model to a function-oriented approach, and ultimately promoting aging in place and independent living.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Taipei, Tchaj-wan
- National Taiwan University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged 65 years or older and assessed as Long-Term Care (LTC) need level 2 or above.
- Regularly attending adult day care services at least two days per week, with no anticipated termination of services during the study period (approximately three months).
- Short Portable Mental Status Questionnaire (SPMSQ) results indicating intact, mild, or moderate cognitive impairment, with the ability to understand simple instructions and participate in activities with assistance.
- Able to ambulate independently (assistive devices permitted), with a Short Physical Performance Battery (SPPB) score < 9, indicating functional decline and high risk of falls.
- A score ≥ 9 on the Short Falls Efficacy Scale International (Short FES-I), indicating at least moderate fear of falling.
- Willing to participate in the study and able to provide written informed consent.
Exclusion Criteria:
- History of fracture, major fall, or need for acute medical treatment within the past three months, or deemed by a physician to be unsuitable for moderate or higher levels of physical activity.
- Presence of acute psychiatric symptoms that prevent participation in assessments or study procedures.
- Severe visual or hearing impairments that interfere with activity participation or assessment.
- Currently receiving other intensive rehabilitation or participating in another research intervention.
- Demonstrates a clear lack of willingness to participate in the intervention or is unable to complete the three-month observation period.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Reablement intervention
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Based on the principles of reablement care and incorporating the Person-Environment-Occupation (PEO) model, the intervention is designed according to older adults' individual preferences, life experiences, and functional needs. It consists of context-based, function-oriented activities embedded in daily life situations. The intervention is delivered in small groups (5-10 participants per group), where individualized reablement activities are implemented alongside shared tasks tailored to real-life contexts (e.g., community shopping, cooking, or environmental organization). A designated care staff member is responsible for facilitation, assistance, and documentation. The intervention is conducted 2 to 3 days per week, with multiple short activity sessions per day, each lasting approximately 5 to 60 minutes, over a period of 12 weeks, with a total intervention time of approximately 1,000 minutes. |
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Aktivní komparátor: Exercise intervention
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The Vivifrail exercise program was adopted, an evidence-based intervention model for older adults developed based on international research (Izquierdo, 2019). Through graded, structured exercise training, the program aims to improve lower-limb muscle strength, balance, and gait function. In this study, it was used as a standardized exercise intervention for comparison with the reablement intervention. The program was delivered in small groups (5-10 participants per group), led by designated care staff. Each participant received exercise training corresponding to their functional level. The intervention was conducted 2 to 3 days per week, with each session lasting 30 to 40 minutes, over a period of 12 weeks, with a total intervention time of approximately 1,000 minutes. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Mobility
Časové okno: From enrollment to the end of treatment at 12 weeks
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Short Physical Performance Battery.
It comprises three tests-balance, 4-meter walk, and chair stands-with scores ranging from 0-12, where lower scores indicate higher disability and frailty.
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From enrollment to the end of treatment at 12 weeks
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Fear of fall
Časové okno: From enrollment to the end of treatment at 12 weeks
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Short Falls Efficacy Scale International.
It is a 7-item questionnaire where individuals are instructed to score their concern of falling during an activity on a 4-point Likert scale.
Scores range from 7-28, where higher scores indicate higher level of fear of falling.
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From enrollment to the end of treatment at 12 weeks
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Number and severity of falls
Časové okno: From enrollment to the end of treatment at 12 weeks, every week.
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The Fall Record Form is used to document the frequency, location, and severity of the fall incident, and to provide additional details in the remarks section, including any injuries sustained and subsequent management or interventions.
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From enrollment to the end of treatment at 12 weeks, every week.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Activities of daily living
Časové okno: From enrollment to the end of treatment at 12 weeks
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Barthel Index It is one of the most commonly used clinical tools for evaluating activities of daily living (ADL).
It has a total score of 100, with lower scores indicating poorer self-care ability and a higher level of dependence on others.
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From enrollment to the end of treatment at 12 weeks
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Activities of Daily Living
Časové okno: From enrollment to the end of treatment at 12 weeks
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Lawton IADL Scale.
It is an 8-item assessment tool to measure an older adult's ability to perform complex daily tasks necessary for community living.
It rates independence in areas like finances, transportation, and medication management, with higher scores (0-8) indicating greater autonomy.
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From enrollment to the end of treatment at 12 weeks
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Activities of Daily Living
Časové okno: From enrollment to the end of treatment at 12 weeks
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Individualized Activity Goal Performance Scale.
It is a simplified adaptation grounded in Canadian Occupational Performance Measure (COPM).
Participants engage in a structured interview to select meaningful activities from common day care center tasks and may also add other personally relevant goals.
For each selected activity, participants rate their perceived performance on a scale from 1 to 10 (1 = unable to perform at all; 10 = performs very well).
The overall score is then calculated by averaging the ratings across all selected activities.
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From enrollment to the end of treatment at 12 weeks
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Well-being
Časové okno: From enrollment to the end of treatment at 12 weeks
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Chinese Happiness Inventory.
It is based on the Oxford Happiness Inventory, developed by Lu Luo incorporated culturally specific sources of well-being relevant to Chinese populations.
It adopts a 4-point Likert scale scoring system, with response options ranging from 0 to 3 and a total score range of 0 to 30.
Higher scores indicate a greater level of subjective well-being.
Considering older adults' language comprehension and life context, items originally categorized under the "work achievement" dimension were modified to reflect a broader "sense of accomplishment in daily life," thereby enhancing applicability and interpretability for the target population.
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From enrollment to the end of treatment at 12 weeks
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 202510081RINE
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Klinické studie na Reablement
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Norwegian University of Science and TechnologySt. Olavs Hospital; Trondheim KommuneStaženoAstenie | Omezení mobility
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Aileen BergströmForteNábor
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Frode F. JacobsenUniversity of Bergen; Diakonhjemmet HospitalDokončenoTělesné postiženíNorsko
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Frode F. JacobsenUniversity of Oslo; University of BergenNeznámý
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Mälardalen UniversityDokončenoRehabilitace obnovením funkceŠvédsko