Frail ElderlyNCT01991639
Healthy Life for Frail Malnourished Seniors Performed Together With Trained Lay Buddies
A study testing Nutritional and physical activity intervention in people with Frail Elderly and Malnutrition, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly, Malnutrition
- What is being tested?
- Nutritional and physical activity intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Dialysis patient
- Cannot understand the German language
- Impaired cognitive function according to the MMSE (≤ 17 points)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute of Social Medicine, Centre for Public Health
Vienna, 1090
About this study
Official title: Nutrition Intervention and Physical Training in Malnourished, Frail, Community-dwelling, Elderly Subjects Carried Out by 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.
- Conditions
- Frail Elderly, Malnutrition
- Being tested
- Nutritional and physical activity intervention
- Keywords
- frailty, community-dwelling, malnutrition, physical activity, nutritional intervention
- Medical subject headings
- Malnutrition, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and physical activity interventionOther
Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.
| Study group | Role | What they receive |
|---|---|---|
| cognitive training | No intervention | 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 | Experimental | Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions. Receives: Other: Nutritional and physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
Measured: Before the intervention, after 10-12 weeks and after 6 and 12 months
Secondary outcomes (23)
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).
Measured: 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
For the assessment of frailty the SHARE-FI as used in the Survey of Health, Ageing and Retirement in Europe will be applied.
Measured: 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
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".
Measured: 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
The social support is assessed by the Fragebogen zur sozialen Unterstützung (FSozU K-14).
Measured: 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
Laboratory parameters (albumin, total cholesterol, transferrin, triglyceride, 25-hydroxy-vitamin D, folic acid, CRP, IL-6, TNF-alpha and leucocytes)
Measured: Before the intervention, after 10-12 weeks, and after 6 months
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).
Measured: Before the intervention, after 10-12 weeks and after 6 months
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
Measured: 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
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.
Measured: 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
The Short Physical Performance Battery (SPPB) is a method for assessing physical performance of older patients.
Measured: 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
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)
Measured: 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
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
Measured: Before the intervention, after 10-12 weeks and after 6 months
Measures of drop-out after 10-12 weeks
Measured: Afer 10-12 weeks
Measures of adherence after 10 -12 weeks
Measured: after 10 -12 weeks
Appraisal of the participant after 10-12 weeks
Measured: after 10-12 weeks
Documentation of any undesirable event during the intervention after 6 months
Measured: after 6 months
Changes from baseline in frequency of hospitalization at 10-12 weeks and at 6 months
Measured: 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
Measured: 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
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)
Measured: Before the intervention, after 10-12 weeks and after 6 months
Measures of drop-out after 6 months
Measured: Afer 6 months
Measures of adherence after 6 months
Measured: after 6 months
Expectations of the participant before the intervention
Measured: Before the intervention
Appraisal of the participant after 6 months
Measured: after 6 months
Documentation of any undesirable event during the intervention after 10-12 weeks
Measured: after 10 -12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priv. Doz. Thomas E. Dorner, Medical University of Vienna
- Investigators
- Thomas E Dorner, Priv.Doz., Principal investigator, Institut für Sozialmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991639
- Sponsor's protocol ID
- 12-039
- Status last verified
- Feb 2016
- First submitted
- 6 Nov 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33920981Grabovac 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.
PubMed 30094663Kapan 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.
PubMed 28724351Dorner 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.
PubMed 24369785
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention and Physical Training in Malnourished, Frail, Community-dwelling, Elderly Subjects Carried Out by Trained Lay "Buddies"
- ClinicalTrials.gov ID
- NCT01991639
- Acronym / sponsor ID
- 12-039
- Conditions
- Frail Elderly, Malnutrition
- Keywords
- frailty, community-dwelling, malnutrition, physical activity, nutritional intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive training | No intervention | –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 | Experimental | Other: Nutritional and physical activity interventionBuddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional and physical activity interventionBuddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions. | Other | nutritional & physical activity |
Primary outcome
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
23 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Measures of drop-out after 10-12 weeks
Time frame: Afer 10-12 weeks
Measures of adherence after 10 -12 weeks
Time frame: after 10 -12 weeks
Appraisal of the participant after 10-12 weeks
Time frame: after 10-12 weeks
Documentation of any undesirable event during the intervention after 6 months
Time frame: after 6 months
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
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
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
Measures of drop-out after 6 months
Time frame: Afer 6 months
Measures of adherence after 6 months
Time frame: after 6 months
Expectations of the participant before the intervention
Time frame: Before the intervention
Appraisal of the participant after 6 months
Time frame: after 6 months
Documentation of any undesirable event during the intervention after 10-12 weeks
Time frame: after 10 -12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Derived from this study: PubMed 33920981Lackinger 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.
- Derived from this study: PubMed 30094663Grabovac 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.
- Derived from this study: PubMed 28724351Kapan 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.
- Derived from this study: PubMed 24369785Dorner 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E Dorner, Priv.Doz. principal investigator
Institut für Sozialmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional and physical activity intervention in people with Frail Elderly and Malnutrition, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991639, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.