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Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program

12 juillet 2021 mis à jour par: Fundacion Miguel Servet

Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Elderly: Study Protocol for a Randomized Multicenter Clinical Trial

The hospitalized elderly patient is conditioned by a series of circumstances unrelated to the pathological process itself that caused hospital admission and that usually worsen the results of hospitalization. In fact, the implementation of care models different from the traditional ones has shown a clear benefit in the functional results of these patients in the short and medium term. However, the components of these models that explain these better results have not been differentially evaluated. Some examples of these circumstances are the usual orders of absolute rest without any objective criteria for patients who are able to wander, the perpetuation of continuous fluid therapy, physical and chemical restraints, unnecessary permanent probes, etc. On numerous occasions, hospitalized elderly patients spend most of their time in bed, reaching even more than 83% of bedridden compared to 4% of those who stand up or are walking. The average time that a geriatric patient walks during their hospitalization ranges from 7 to 43 minutes/day. This population, by having their functional and physiological reserve reduced, are more vulnerable to the effects, for example, of bedridden, which range from functional loss or cognitive impairment, to longer stays, mortality and institutionalization, worse emotional situation, delirium, deconditioning, aspirations, pressure ulcers, and falls, decreased caloric intake, social isolation, poorer quality of life, and greater use of health-related resources. This study is a multicenter randomized clinical trial to be conducted in the acute care for elderly (ACE) units of three tertiary hospitals in Spain - Complejo Hospitalario de Navarra (CHN), Hospital Central de la Cruz Roja de Madrid (HCCRM) and Complejo Hospitalario Universitario of Albacete (CHUA). After randomization, the research team (physiotherapist, sport science specialist and geriatrician) will together perform the baseline measurement and follow-up visits of functional, pharmacological, comorbidity and cognitive assessment, as well as of mobility and strength evaluations. The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening).

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Navarra
      • Pamplona, Navarra, Espagne, 31008
        • Complejo Hospitalario de Navarra. Department of Geriatrics

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

75 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • > 75 years
  • Barthel Index ≥60 points
  • Able to ambulate (with/without assistance)
  • Sing the informed consent
  • Able to communicate

Exclusion Criteria:

  • Expected length of stay <6 days
  • Terminal illness
  • Very severe cognitive decline (i.e., GDS 7)
  • Uncontrolled arrhythmias, acute pulmonary embolism and myocardial infarction, or extremity bone fracture in the past 3 months.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
Aucune intervention: Groupe de soins habituels
Soins habituels
Expérimental: Training group

Multicomponent exercise group (intervention): The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening).

The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RMcombined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.

The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day. The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RM combined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.
Autres noms:
  • Multicomponent exercise intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Rate of patients with change in functional and cognitive status
Délai: 3 years
The functional capacity of participants will be evaluated by the Short Physical Performance Battery (SPPB), the total score ranging from 0 (worst) to 12 points (best) which includes balance, gait and rising from a chair test. Standing balance test consists in the ability to maintain the standing position for 10s with three different foot position: parallel, semi-tandem and tandem. Walking speed measure, the time needed to progress for 4 linear meters with patient's usual speed, assigning a different score according to speed. Chair sit-to-stand assesses the ability to stand from a chair 5 consecutive times without using arms. The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality.
3 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of changes in the quality of life
Délai: 3 years
- Changes in the quality of life measured by the Spanish version40 of the questionnaire EuroQol-5 Dimension (EQ-5D)41. It is an instrument measures 5 dimensions health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated according to the following levels: a) no problems; b) some problems; c) extreme problems. Besides, it contain visual analogy scale to quantify perceived health of 0 (worst health state imaginable) to 100 (best health state imaginable).
3 years
Number of patients with delirium
Délai: 3 years
Development of delirium as assessed with the Confusion Assessment Method (CAM); feature 1, acute onset and fluctuating course; feature 2, inattention; feature 3, disorganized thinking; and feature 4, altered level of consciousness, with diagnosis of delirium requiring the presence of features 1 and 2 and either 3 or 442.
3 years
Mortality Rate
Délai: 3 years
3-years mortality
3 years
Total use of health-related resources
Délai: 3 years
Number of readmissions, visits to A&E, visits to outpatient clinics
3 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 mai 2018

Achèvement primaire (Réel)

31 mai 2021

Achèvement de l'étude (Réel)

1 juin 2021

Dates d'inscription aux études

Première soumission

19 octobre 2020

Première soumission répondant aux critères de contrôle qualité

22 octobre 2020

Première publication (Réel)

23 octobre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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