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Healthy Life for Frail Malnourished Seniors Performed Together With Trained Lay Buddies

2 février 2016 mis à jour par: Priv. Doz. Thomas E. Dorner, Medical University of Vienna

Nutrition Intervention and Physical Training in Malnourished, Frail, Community-dwelling, Elderly Subjects Carried Out by Trained Lay "Buddies"

Background: In elderly subjects frailty and malnutrition are very common and can lead to serious health hazards, increase mortality, morbidity, dependency, institutionalization and a reduced quality of life. In Austria, the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system. Physical training and adequate nutrition can invert it.

Methods/Design: In this randomized, controlled trial 80 malnourished, frail, community-dwelling patients (≥ 65 years) are recruited. Additionally, 80 lay volunteers (≥ 50 years) named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in three standardized training sessions. These buddies visit the malnourished, frail subjects at home twice a week for about one hour during an initial period of 10-12 weeks. While participants allocated to the intervention group (n=40) conduct intervention to improve their fluid intake, their protein and energy intake, perform strength training and try to increase their baseline activities, the control group (n=40) only gets home visits without any special intervention. After 10-12 weeks, both, the intervention and the control group, receive the nutrition intervention and the physical training. Health, nutrition and frailty status, physical fitness and body composition and chronic inflammation of buddies and frails are recorded before the intervention, after 10-12 weeks, and after 6 and 12 months.

Discussion: To the investigators knowledge this trial is the first of its kind to provide nutrition and physical activity intervention to malnourished, frail, community-dwelling subjects by trained lay buddies, in which the health status of buddies is also expected to improve. This study assesses the effectiveness of such an intervention. If successful, the intervention offers new perspectives for the management of frailty and malnutrition.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

80

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

  • L'Autriche
      • Vienna, L'Autriche, 1090
        • Institute of Social Medicine, Centre for Public Health

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

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria frail, malnourished subjects:

  • 65 years or older
  • Living in Vienna
  • Hospital discharged planned for the next 14 days
  • Malnutrition or at risk of malnutrition according to the MNA-SF
  • Frail or pre-frail according to the SHARE-FI
  • Community-dwelling
  • No medical contraindication for the performance of physical strength training
  • Able to walk (with or without a walking aid)
  • Capability to consent

Exclusion Criteria frail, malnourished subjects:

  • 65 years or younger
  • Admission to nursing home is planned
  • Nursing level 6 or 7
  • Cancer according to the medical charts
  • Insulin treated diabetes mellitus according to the medical charts
  • COPD stage III or IV
  • Dialysis patient
  • Cannot understand the German language
  • Impaired cognitive function according to the MMSE (≤ 17 points)

Inclusion Criteria buddies:

  • 50 years or older
  • Signed informed consent
  • Readiness to participate in the study as well in the intervention as in the control group
  • Commitment to keep to the protocol for at least 6 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

  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: cognitive training
Participants are visited twice a week by buddies, but they do not specifically monitor the nutritional status or perform physical training in the first 10-12 weeks. Instead of that buddies are provided with a portfolio of possible activities, especially cognitive training, which they could perform together with the frail, malnourished subjects.
Expérimental: nutritional & physical activity
Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.
Autre: Nutritional and physical activity intervention
Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
Délai: Before the intervention, after 10-12 weeks and after 6 and 12 months
Before the intervention, after 10-12 weeks and after 6 and 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in nutritional status at 10-12 weeks and at 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Risk for malnutrition is assessed by the long form of the mini nutritional assessment (MNA).
Before the intervention, after 10-12 weeks and after 6 months
Change from baseline is frailty status at 10-12 weeks and at 6 and 12 months
Délai: Before the intervention, after 10 -12 weeks and after 6 and 12 months
For the assessment of frailty the SHARE-FI as used in the Survey of Health, Ageing and Retirement in Europe will be applied.
Before the intervention, after 10 -12 weeks and after 6 and 12 months
Change from baseline in quality of life at 10-12 weeks and at 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Quality of life is assessed by the WHOQOL-BREF and by 3 dimensions of the WHOQOL-OLD ("sensory functions", "autonomy", "activities in the past, present and future".
Before the intervention, after 10-12 weeks and after 6 months
Changes from baseline in social support at 10-12 weeks and at 6 months
Délai: before the intervention, after 10-12 weeks and after 6 months
The social support is assessed by the Fragebogen zur sozialen Unterstützung (FSozU K-14).
before the intervention, after 10-12 weeks and after 6 months
Changes from baseline in sings of malnutrition and frailty at 10-12 weeks and at 6 months
Délai: Before the intervention, after 10-12 weeks, and after 6 months
Laboratory parameters (albumin, total cholesterol, transferrin, triglyceride, 25-hydroxy-vitamin D, folic acid, CRP, IL-6, TNF-alpha and leucocytes)
Before the intervention, after 10-12 weeks, and after 6 months
Changes from baseline in cognitiv function at 10-12 weeks and at 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Cognitiv function is assessed by the Mini Mental State Examination (MMSE).
Before the intervention, after 10-12 weeks and after 6 months
Changes from baseline in muscle strength after 10-12 weeks and 6 months
Délai: Before the intervention, after 10 -12 weeks and after 6 months
Muscle strength is assessed by the MASS (Measurement of age and sex related reference values of muscle strength) and the Concept dyno 2. The MASS is a new diagnosis system which was developed by the Technical University of Vienna. It evaluates health related concentric dynamic muscle strength. The measurement is velocity-independent and hence, is appropriate for the target group. Three exercises (bench press, bench pull, and leg press) will be conducted in standardized procedure. For all tested muscle groups the following parameters are recorded: maximum resistance with low velocity and 2-3 fix adjusted sub-maximum loads. Moreover, the Concept 2 dyno is used for assessing the muscle strength. The same exercises as before will be conducted in standardized procedure and the results are analyzed according to the reference values
Before the intervention, after 10 -12 weeks and after 6 months
Changes from baseline in the amount of physical activity at 10-12 weeks and 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months

The amount of physical activity is assessed by the Physical Activity Scale for the Elderly (PASE) and a modified version of the FEG (Fragebogen zur Erfassung des Gesundheitsverhaltens).

Moreover each patient receives a pedometer to measure the daily steps.
Before the intervention, after 10-12 weeks and after 6 months
Changes from baseline in balance and mobility components at 10-12 weeks and at 6 months
Délai: Before the intervenion, after 10-12 weeks and after 6 months
The Short Physical Performance Battery (SPPB) is a method for assessing physical performance of older patients.
Before the intervenion, after 10-12 weeks and after 6 months
Changes from baseline in qualitative and quantitative contents of refrigerator at 10-12 weeks and at 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Predefined protocol of the refrigerator of the frail individuals will assess the refrigerator contents which will be classified as adequate, inadequate (rotten food or just beyond the date stamped on the label), or empty (less than three different food products)
Before the intervention, after 10-12 weeks and after 6 months
Changes from baseline in quality of the whole diet at 10-12 week and at 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Changes in the quality of the whole diet is assesseb by Mediterranean Diet Adherence Screener (MEDIAS), a food frequency questionnaire assessing the protein intake and questions concerning supplements
Before the intervention, after 10-12 weeks and after 6 months
Measures of drop-out after 10-12 weeks
Délai: Afer 10-12 weeks
Afer 10-12 weeks
Measures of adherence after 10 -12 weeks
Délai: after 10 -12 weeks
after 10 -12 weeks
Appraisal of the participant after 10-12 weeks
Délai: after 10-12 weeks
after 10-12 weeks
Documentation of any undesirable event during the intervention after 6 months
Délai: after 6 months
after 6 months
Changes from baseline in frequency of hospitalization at 10-12 weeks and at 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Before the intervention, after 10-12 weeks and after 6 months
Changes from baseline in frequency of falls at 10-12 weeks and 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Before the intervention, after 10-12 weeks and after 6 months
Changes from baseline in fear of fallings at 10-12 week and at 6 months
Délai: Before the intervention, after 10-12 weeks and after 6 months
Falls Efficacy Scale International (FES-I) was developed for the documentation of fall-related self-efficacy in older persons by an EU-funded expert network (Prevention of Falls Network Europe ProFaNE)
Before the intervention, after 10-12 weeks and after 6 months
Measures of drop-out after 6 months
Délai: Afer 6 months
Afer 6 months
Measures of adherence after 6 months
Délai: after 6 months
after 6 months
Expectations of the participant before the intervention
Délai: Before the intervention
Before the intervention
Appraisal of the participant after 6 months
Délai: after 6 months
after 6 months
Documentation of any undesirable event during the intervention after 10-12 weeks
Délai: after 10 -12 weeks
after 10 -12 weeks

Collaborateurs et enquêteurs

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

Parrainer

Medical University of Vienna

Les enquêteurs

  • Chercheur principal: Thomas E Dorner, Priv.Doz., Institut für Sozialmedizin

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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

1 janvier 2014

Achèvement primaire (Réel)

1 décembre 2015

Achèvement de l'étude (Réel)

1 décembre 2015

Dates d'inscription aux études

Première soumission

6 novembre 2013

Première soumission répondant aux critères de contrôle qualité

18 novembre 2013

Première publication (Estimation)

25 novembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 février 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 février 2016

Dernière vérification

1 février 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 12-039

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

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

produit fabriqué et exporté des États-Unis.

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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