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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Frail Elderly Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

nutritional & physical activity

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

Group Type EXPERIMENTAL

Nutritional and physical activity intervention

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes