Nutrition Intervention and Physical Training in Malnourished, Frail, Community-dwelling, Elderly Subjects Carried Out by Trained Lay "Buddies"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
nutritional & physical activity
Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.
Intervention: Nutritional and physical activity intervention (Other)
Outcomes
Primary Outcomes
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
- Measures of adherence after 6 months(after 6 months)
- Documentation of any undesirable event during the intervention after 10-12 weeks(after 10 -12 weeks)
- Changes from baseline in cognitiv function at 10-12 weeks and at 6 months(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(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(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(Before the intervention, after 10-12 weeks and after 6 months)
- Measures of drop-out after 10-12 weeks(Afer 10-12 weeks)
- Measures of adherence after 10 -12 weeks(after 10 -12 weeks)
- Appraisal of the participant after 10-12 weeks(after 10-12 weeks)
- Documentation of any undesirable event during the intervention after 6 months(after 6 months)
- Change from baseline in nutritional status at 10-12 weeks and at 6 months(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(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(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(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(Before the intervention, after 10-12 weeks, and after 6 months)
- Changes from baseline in muscle strength after 10-12 weeks and 6 months(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(Before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in frequency of hospitalization at 10-12 weeks and at 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(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(Before the intervention, after 10-12 weeks and after 6 months)
- Measures of drop-out after 6 months(Afer 6 months)
- Expectations of the participant before the intervention(Before the intervention)
- Appraisal of the participant after 6 months(after 6 months)
Investigators
Priv. Doz. Thomas E. Dorner
Priv. Doz
Medical University of Vienna