Clinical trial NCT01991639: Healthy Life for Frail Malnourished Seniors Performed Together With Trained Lay Buddies
Official title: Nutrition Intervention and Physical Training in Malnourished, Frail, Community-dwelling, Elderly Subjects Carried Out by Trained Lay "Buddies"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Malnutrition
Keywords: frailty
community-dwelling
malnutrition
physical activity
nutritional intervention
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 and 12 months
Secondary outcomes:
measure: Change from baseline in nutritional status at 10-12 weeks and at 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Change from baseline is frailty status at 10-12 weeks and at 6 and 12 months
timeFrame: Before the intervention, after 10 -12 weeks and after 6 and 12 months
measure: Change from baseline in quality of life at 10-12 weeks and at 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Changes from baseline in social support at 10-12 weeks and at 6 months
timeFrame: before the intervention, after 10-12 weeks and after 6 months
measure: Changes from baseline in sings of malnutrition and frailty at 10-12 weeks and at 6 months
timeFrame: Before the intervention, after 10-12 weeks, and after 6 months
measure: Changes from baseline in cognitiv function at 10-12 weeks and at 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Changes from baseline in muscle strength after 10-12 weeks and 6 months
timeFrame: Before the intervention, after 10 -12 weeks and after 6 months
measure: Changes from baseline in the amount of physical activity at 10-12 weeks and 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Changes from baseline in balance and mobility components at 10-12 weeks and at 6 months
timeFrame: Before the intervenion, after 10-12 weeks and after 6 months
measure: Changes from baseline in qualitative and quantitative contents of refrigerator at 10-12 weeks and at 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Changes from baseline in quality of the whole diet at 10-12 week and at 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Measures of drop-out after 10-12 weeks
timeFrame: Afer 10-12 weeks
measure: Measures of adherence after 10 -12 weeks
timeFrame: after 10 -12 weeks
measure: Appraisal of the participant after 10-12 weeks
timeFrame: after 10-12 weeks
measure: Documentation of any undesirable event during the intervention after 6 months
timeFrame: after 6 months
measure: Changes from baseline in frequency of hospitalization at 10-12 weeks and at 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Changes from baseline in frequency of falls at 10-12 weeks and 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Changes from baseline in fear of fallings at 10-12 week and at 6 months
timeFrame: Before the intervention, after 10-12 weeks and after 6 months
measure: Measures of drop-out after 6 months
timeFrame: Afer 6 months
measure: Measures of adherence after 6 months
timeFrame: after 6 months
measure: Expectations of the participant before the intervention
timeFrame: Before the intervention
measure: Appraisal of the participant after 6 months
timeFrame: after 6 months
measure: Documentation of any undesirable event during the intervention after 10-12 weeks
timeFrame: after 10 -12 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Institute of Social Medicine, Centre for Public Health
Study officials:
affiliation: Institut für Sozialmedizin
name: Thomas E Dorner, Priv.Doz.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lackinger C, Grabovac I, Haider S, Kapan A, Winzer E, Stein KV, Dorner TE. Adherence Is More Than Just Being Present: Example of a Lay-Led Home-Based Programme with Physical Exercise, Nutritional Improvement and Social Support, in Prefrail and Frail Community-Dwelling Older Adults. Int J Environ Res Public Health. 2021 Apr 15;18(8):4192. doi: 10.3390/ijerph18084192.
citation: Grabovac I, Haider S, Winzer E, Kapan A, Schindler KE, Lackinger C, Dorner TE. Changes in health parameters in older lay volunteers who delivered a lifestyle-based program to frail older people at home. Wien Klin Wochenschr. 2018 Nov;130(21-22):637-644. doi: 10.1007/s00508-018-1372-6. Epub 2018 Aug 9.
citation: Kapan A, Winzer E, Haider S, Titze S, Schindler K, Lackinger C, Dorner TE. Impact of a lay-led home-based intervention programme on quality of life in community-dwelling pre-frail and frail older adults: a randomized controlled trial. BMC Geriatr. 2017 Jul 19;17(1):154. doi: 10.1186/s12877-017-0548-7.
citation: Dorner TE, Lackinger C, Haider S, Luger E, Kapan A, Luger M, Schindler KE. Nutritional intervention and physical training in malnourished frail community-dwelling elderly persons carried out by trained lay "buddies": study protocol of a randomized controlled trial. BMC Public Health. 2013 Dec 27;13:1232. doi: 10.1186/1471-2458-13-1232.