- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07686146
Multicomponent Exercise and Frailty in Nursing Home Residents (BASE-Frail)
Effects of a Multicomponent Exercise Program on Frailty in Institutionalized Older Adults: A Multicenter Controlled Study
Frailty is common among older adults living in nursing homes and increases the risk of falls, disability, and loss of independence. However, there is limited evidence on practical and feasible exercise programs adapted to this population.
This study evaluated the effects of a multicomponent exercise program combining strength and balance training in residents aged 65 years and older. Participants were assigned to either an intervention group, which performed supervised exercise sessions twice a week for 8 weeks, or a control group, which continued their usual activities.
The main outcome was frailty, measured using the Short Physical Performance Battery. Other outcomes included balance, functional independence, sarcopenia, fear of falling, and number of falls.
This study was retrospectively registered.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Frailty is a multidimensional clinical condition highly prevalent among older adults living in institutional settings and is associated with increased risk of falls, disability, hospitalization, and mortality. Despite growing evidence supporting physical exercise interventions, there is still a need for structured, feasible, and clinically applicable programs specifically designed for nursing home residents.
This study aimed to evaluate the effects of a multicomponent exercise program on frailty and related outcomes in institutionalized older adults. A multicenter, controlled, non-randomized design was used, including participants recruited from eight nursing homes.
Participants aged 65 years and older were allocated by residential center to either an intervention group or a control group. The intervention group participated in the Balance and Strength Exercises (BASE) program, consisting of supervised sessions performed twice weekly for 8 weeks. Each session included a combination of strength and balance exercises with progressive levels adapted to individual capacity. The control group continued their usual care and routine activities.
The primary outcome was frailty, assessed using the Short Physical Performance Battery (SPPB). Secondary outcomes included balance, measured with the Performance-Oriented Mobility Assessment (POMA); sarcopenia, measured with the Strength, Assistance with Walking, Rise from a Chair, Climb Stairs, and Falls Questionnaire (SARC-F); functional independence, measured with the Barthel Index; fear of falling, measured with the Short Falls Efficacy Scale-International (Short FES-I); and the number of falls occurring during the study period.
Assessments were conducted at baseline, immediately after the intervention (8 weeks), and at follow-up (20 weeks). The study evaluated both the immediate effects of the intervention and the persistence of outcomes after cessation.
This study was retrospectively registered following completion of data collection.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Barcelona
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Sant Cugat del Vallès, Barcelona, Španělsko, 08174
- Escoles Universitàries Gimbernat
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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
- Living in a nursing home
- Ability to walk at least 10 meters (with or without assistive devices)
- Mini-Mental State Examination (MMSE) score ≥19
Exclusion Criteria:
- Neurodegenerative diseases
- Advanced dementia
- Parkinson's disease
- Hemodynamic instability
- Lower limb fractures under rehabilitation within the past year
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: Multicomponent Exercise Program (BASE)
Participants engaged in a supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks.
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A supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks.
Each session lasted 30-40 minutes and included warm-up, strength exercises, and progressively adapted balance tasks based on individual capacity.
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Jiný: Usual Care
Participants continued their usual care and routine activities provided by their nursing homes.
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Participants continued their usual care and routine physical activities provided by the nursing homes without additional structured intervention.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Frailty assessed by the Short Physical Performance Battery (SPPB)
Časové okno: Baseline to 8 weeks
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Frailty was measured using the Short Physical Performance Battery (SPPB), which includes assessments of balance, gait speed, and chair rise performance.
Total scores range from 0 to 12, with higher scores indicating better physical performance.
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Baseline to 8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Balance assessed by the Performance-Oriented Mobility Assessment (POMA)
Časové okno: Baseline, 8 weeks, and 20 weeks
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Balance was measured using the Performance-Oriented Mobility Assessment (POMA), which evaluates static and dynamic balance as well as gait performance.
Total scores range from 0 to 28, with higher scores indicating better balance and mobility.
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Baseline, 8 weeks, and 20 weeks
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Sarcopenia assessed by SARC-F
Časové okno: Baseline, 8 weeks, and 20 weeks
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Sarcopenia was measured using the Strength, Assistance with Walking, Rise from a Chair, Climb Stairs, and Falls Questionnaire (SARC-F), a self-reported screening tool for sarcopenia risk.
Total scores range from 0 to 10, with higher scores indicating a greater risk of sarcopenia.
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Baseline, 8 weeks, and 20 weeks
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Functional independence assessed by the Barthel Index
Časové okno: Baseline, 8 weeks, and 20 weeks
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Functional independence was measured using the Barthel Index, which assesses the ability to perform activities of daily living, including feeding, bathing, dressing, toileting, mobility, and stair climbing.
Total scores range from 0 to 100, with higher scores indicating greater functional independence.
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Baseline, 8 weeks, and 20 weeks
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Fear of falling assessed by Short FES-I
Časové okno: Baseline, 8 weeks, and 20 weeks
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Fear of falling was measured using the Short Falls Efficacy Scale-International (Short FES-I), which assesses concerns about falling during everyday activities.
Total scores range from 7 to 28, with higher scores indicating greater fear of falling.
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Baseline, 8 weeks, and 20 weeks
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Number of falls
Časové okno: Throughout the 20-week study period
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Falls were measured as the total number of falls recorded during the study period using incident reports from the participating nursing homes.
Higher values indicate a greater frequency of falls.
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Throughout the 20-week study period
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
- CEEAH-UAB-5654
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