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

2016年2月2日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • オーストリア
      • Vienna、オーストリア、1090
        • Institute of Social Medicine, Centre for Public Health

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：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.
実験的：nutritional & physical activity
Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in nutritional status at 10-12 weeks and at 6 months
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Afer 10-12 weeks
Afer 10-12 weeks
Measures of adherence after 10 -12 weeks
時間枠：after 10 -12 weeks
after 10 -12 weeks
Appraisal of the participant after 10-12 weeks
時間枠：after 10-12 weeks
after 10-12 weeks
Documentation of any undesirable event during the intervention after 6 months
時間枠：after 6 months
after 6 months
Changes from baseline in frequency of hospitalization at 10-12 weeks and at 6 months
時間枠：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
時間枠：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
時間枠：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
時間枠：Afer 6 months
Afer 6 months
Measures of adherence after 6 months
時間枠：after 6 months
after 6 months
Expectations of the participant before the intervention
時間枠：Before the intervention
Before the intervention
Appraisal of the participant after 6 months
時間枠：after 6 months
after 6 months
Documentation of any undesirable event during the intervention after 10-12 weeks
時間枠：after 10 -12 weeks
after 10 -12 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Medical University of Vienna

捜査官

  • 主任研究者：Thomas E Dorner, Priv.Doz.、Institut für Sozialmedizin

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年1月1日

一次修了 (実際)

2015年12月1日

研究の完了 (実際)

2015年12月1日

試験登録日

最初に提出

2013年11月6日

QC基準を満たした最初の提出物

2013年11月18日

最初の投稿 (見積もり)

2013年11月25日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年2月3日

QC基準を満たした最後の更新が送信されました

2016年2月2日

最終確認日

2016年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 12-039

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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