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Multicomponent Exercise and Frailty in Nursing Home Residents (BASE-Frail)

1 luglio 2026 aggiornato da: Jadrana Sore, Escoles Universitaries Gimbernat

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

66

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spagna, 08174
        • Escoles Universitàries Gimbernat

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Multicomponent Exercise Program (BASE)
Participants engaged in a supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks.
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.
Altro: Usual Care
Participants continued their usual care and routine activities provided by their nursing homes.
Participants continued their usual care and routine physical activities provided by the nursing homes without additional structured intervention.
Altri nomi:
  • Cura standard

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frailty assessed by the Short Physical Performance Battery (SPPB)
Lasso di tempo: Baseline to 8 weeks
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.
Baseline to 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Balance assessed by the Performance-Oriented Mobility Assessment (POMA)
Lasso di tempo: Baseline, 8 weeks, and 20 weeks
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.
Baseline, 8 weeks, and 20 weeks
Sarcopenia assessed by SARC-F
Lasso di tempo: Baseline, 8 weeks, and 20 weeks
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.
Baseline, 8 weeks, and 20 weeks
Functional independence assessed by the Barthel Index
Lasso di tempo: Baseline, 8 weeks, and 20 weeks
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.
Baseline, 8 weeks, and 20 weeks
Fear of falling assessed by Short FES-I
Lasso di tempo: Baseline, 8 weeks, and 20 weeks
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.
Baseline, 8 weeks, and 20 weeks
Number of falls
Lasso di tempo: Throughout the 20-week study period
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.
Throughout the 20-week study period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 novembre 2021

Completamento primario (Effettivo)

31 gennaio 2022

Completamento dello studio (Effettivo)

31 dicembre 2022

Date di iscrizione allo studio

Primo inviato

25 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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