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

2 de fevereiro de 2016 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Áustria
      • Vienna, Áustria, 1090
        • Institute of Social Medicine, Centre for Public Health

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

65 anos e mais velhos (Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Experimental: nutritional & physical activity
Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in nutritional status at 10-12 weeks and at 6 months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Afer 10-12 weeks
Afer 10-12 weeks
Measures of adherence after 10 -12 weeks
Prazo: after 10 -12 weeks
after 10 -12 weeks
Appraisal of the participant after 10-12 weeks
Prazo: after 10-12 weeks
after 10-12 weeks
Documentation of any undesirable event during the intervention after 6 months
Prazo: after 6 months
after 6 months
Changes from baseline in frequency of hospitalization at 10-12 weeks and at 6 months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Afer 6 months
Afer 6 months
Measures of adherence after 6 months
Prazo: after 6 months
after 6 months
Expectations of the participant before the intervention
Prazo: Before the intervention
Before the intervention
Appraisal of the participant after 6 months
Prazo: after 6 months
after 6 months
Documentation of any undesirable event during the intervention after 10-12 weeks
Prazo: after 10 -12 weeks
after 10 -12 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Medical University of Vienna

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Real)

1 de dezembro de 2015

Conclusão do estudo (Real)

1 de dezembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

6 de novembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de novembro de 2013

Primeira postagem (Estimativa)

25 de novembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

3 de fevereiro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de fevereiro de 2016

Última verificação

1 de fevereiro de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 12-039

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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