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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991639
• Other study ID #: 12-039
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: February 2, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Frail Elderly
• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Austria	Institute of Social Medicine, Centre for Public Health	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months		Before the intervention, after 10-12 weeks and after 6 and 12 months	No
Secondary	Change from baseline in nutritional status at 10-12 weeks and at 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	No
Secondary	Change from baseline is frailty status at 10-12 weeks and at 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	No
Secondary	Change from baseline in quality of life at 10-12 weeks and at 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	No
Secondary	Changes from baseline in social support at 10-12 weeks and at 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	No
Secondary	Changes from baseline in sings of malnutrition and frailty at 10-12 weeks and at 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	No
Secondary	Changes from baseline in cognitiv function at 10-12 weeks and at 6 months	Cognitiv function is assessed by the Mini Mental State Examination (MMSE).	Before the intervention, after 10-12 weeks and after 6 months	No
Secondary	Changes from baseline in muscle strength after 10-12 weeks and 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	No
Secondary	Changes from baseline in the amount of physical activity at 10-12 weeks and 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	No
Secondary	Changes from baseline in balance and mobility components at 10-12 weeks and at 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	No
Secondary	Changes from baseline in qualitative and quantitative contents of refrigerator at 10-12 weeks and at 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	No
Secondary	Changes from baseline in quality of the whole diet at 10-12 week and at 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	No
Secondary	Measures of drop-out after 10-12 weeks		Afer 10-12 weeks	No
Secondary	Measures of adherence after 10 -12 weeks		after 10 -12 weeks	No
Secondary	Appraisal of the participant after 10-12 weeks		after 10-12 weeks	No
Secondary	Documentation of any undesirable event during the intervention after 6 months		after 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	Changes from baseline in fear of fallings at 10-12 week and at 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	No
Secondary	Measures of drop-out after 6 months		Afer 6 months	No
Secondary	Measures of adherence after 6 months		after 6 months	No
Secondary	Expectations of the participant before the intervention		Before the intervention	No
Secondary	Appraisal of the participant after 6 months		after 6 months	No
Secondary	Documentation of any undesirable event during the intervention after 10-12 weeks		after 10 -12 weeks	No