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Completed

NCT Number: NCT01991639

Healthy Life for Frail Malnourished Seniors Performed Together With 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.

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Key information

Conditions

Frail Elderly Behavior Frailty Malnutrition Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Social Medicine, Centre for Public Health

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional and physical activity intervention

Other

Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Risk for malnutrition is assessed by the long form of the mini nutritional assessment (MNA).

  2. 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

    For the assessment of frailty the SHARE-FI as used in the Survey of Health, Ageing and Retirement in Europe will be applied.

  3. 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

    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".

  4. 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

    The social support is assessed by the Fragebogen zur sozialen Unterstützung (FSozU K-14).

  5. 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

    Laboratory parameters (albumin, total cholesterol, transferrin, triglyceride, 25-hydroxy-vitamin D, folic acid, CRP, IL-6, TNF-alpha and leucocytes)

  6. 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

    Cognitiv function is assessed by the Mini Mental State Examination (MMSE).

  7. 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

    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

  8. 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

    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.

  9. 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

    The Short Physical Performance Battery (SPPB) is a method for assessing physical performance of older patients.

  10. 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

    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)

  11. 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

    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

  12. Measures of drop-out after 10-12 weeks

    Time frame: Afer 10-12 weeks

  13. Measures of adherence after 10 -12 weeks

    Time frame: after 10 -12 weeks

  14. Appraisal of the participant after 10-12 weeks

    Time frame: after 10-12 weeks

  15. Documentation of any undesirable event during the intervention after 6 months

    Time frame: after 6 months

  16. 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

  17. 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

  18. 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

    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)

  19. Measures of drop-out after 6 months

    Time frame: Afer 6 months

  20. Measures of adherence after 6 months

    Time frame: after 6 months

  21. Expectations of the participant before the intervention

    Time frame: Before the intervention

  22. Appraisal of the participant after 6 months

    Time frame: after 6 months

  23. Documentation of any undesirable event during the intervention after 10-12 weeks

    Time frame: after 10 -12 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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