Trial record 19 of 1394 for:    Open Studies | "Malnutrition"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Priv. Doz. Thomas E. Dorner, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01991639
First received: November 6, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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) hospitalized in wards for internal medicine 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.


Condition Intervention
Frail Elderly
Malnutrition
Other: Nutritional and physical activity intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Nutrition Intervention and Physical Training in Malnourished, Frail, Community-dwelling, Elderly Subjects Carried Out by Trained Lay "Buddies"

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in nutritional status at 10-12 weeks and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    Risk for malnutrition is assessed by the long form of the mini nutritional assessment (MNA).

  • Change from baseline is frailty status at 10-12 weeks and at 6 and 12 months [ Time Frame: Before the intervention, after 10 -12 weeks and after 6 and 12 months ] [ Designated as safety issue: No ]
    For the assessment of frailty the SHARE-FI as used in the Survey of Health, Ageing and Retirement in Europe will be applied.

  • Change from baseline in quality of life at 10-12 weeks and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    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".

  • Changes from baseline in social support at 10-12 weeks and at 6 months [ Time Frame: before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    The social support is assessed by the Fragebogen zur sozialen Unterstützung (FSozU K-14).

  • Changes from baseline in sings of malnutrition and frailty at 10-12 weeks and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks, and after 6 months ] [ Designated as safety issue: No ]
    Laboratory parameters (albumin, total cholesterol, transferrin, triglyceride, 25-hydroxy-vitamin D, folic acid, CRP, IL-6, TNF-alpha and leucocytes)

  • Changes from baseline in cognitiv function at 10-12 weeks and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    Cognitiv function is assessed by the Mini Mental State Examination (MMSE).

  • Changes from baseline in muscle strength after 10-12 weeks and 6 months [ Time Frame: Before the intervention, after 10 -12 weeks and after 6 months ] [ Designated as safety issue: No ]
    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

  • Changes from baseline in the amount of physical activity at 10-12 weeks and 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]

    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.


  • Changes from baseline in balance and mobility components at 10-12 weeks and at 6 months [ Time Frame: Before the intervenion, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    The Short Physical Performance Battery (SPPB) is a method for assessing physical performance of older patients.

  • Changes from baseline in qualitative and quantitative contents of refrigerator at 10-12 weeks and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    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)

  • Changes from baseline in quality of the whole diet at 10-12 week and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    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

  • Measures of drop-out after 10-12 weeks [ Time Frame: Afer 10-12 weeks ] [ Designated as safety issue: No ]
  • Measures of adherence after 10 -12 weeks [ Time Frame: after 10 -12 weeks ] [ Designated as safety issue: No ]
  • Appraisal of the participant after 10-12 weeks [ Time Frame: after 10-12 weeks ] [ Designated as safety issue: No ]
  • Documentation of any undesirable event during the intervention after 6 months [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline in frequency of hospitalization at 10-12 weeks and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline in frequency of falls at 10-12 weeks and 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline in fear of fallings at 10-12 week and at 6 months [ Time Frame: Before the intervention, after 10-12 weeks and after 6 months ] [ Designated as safety issue: No ]
    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)

  • Measures of drop-out after 6 months [ Time Frame: Afer 6 months ] [ Designated as safety issue: No ]
  • Measures of adherence after 6 months [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • Expectations of the participant before the intervention [ Time Frame: Before the intervention ] [ Designated as safety issue: No ]
  • Appraisal of the participant after 6 months [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • Documentation of any undesirable event during the intervention after 10-12 weeks [ Time Frame: after 10 -12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No 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.
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.
Other: 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991639

Contacts
Contact: Thomas E. Dorner, Priv.-Doz. +4340160 ext 43884 thomas.dorner@meduniwien.ac.at

Locations
Austria
Institute of Social Medicine, Centre for Public Health Not yet recruiting
Vienna, Austria, 1090
Contact: Sandra Haider, Mag.    +4366460613370    s.haider@sportunion.at   
Contact: Eva Luger, MSC    +436504404418    eva.luger@meduniwien.ac.at   
Principal Investigator: Thomas Dorner         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Thomas E Dorner, Priv.Doz. Institut für Sozialmedizin
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Priv. Doz. Thomas E. Dorner, Priv. Doz, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01991639     History of Changes
Other Study ID Numbers: 12-039
Study First Received: November 6, 2013
Last Updated: November 25, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
frailty
community-dwelling
malnutrition
physical activity
nutritional intervention

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 11, 2014