Healthy Life for Frail Malnourished Seniors Performed Together With

Status Completed

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01991639
Study type	Interventional
Source	Medical University of Vienna
Contact
Status	Completed
Phase	N/A
Start date	January 2014
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed	`NCT03268902` - Early Life Interventions for Childhood Growth and Development In Tanzania	Phase 2/Phase 3
Active, not recruiting	`NCT04746664` - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia	N/A
Completed	`NCT04608656` - Livestock for Health Project	N/A
Completed	`NCT06009198` - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan	N/A
Recruiting	`NCT05417672` - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting	`NCT05257980` - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial	N/A
Completed	`NCT03628196` - A Nutrition-Focused QIP in Outpatient Clinics
Completed	`NCT05015647` - Low Protein Diet in CKD Patients at Risk of Malnutrition	N/A
Enrolling by invitation	`NCT04675229` - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting	`NCT04627376` - Multimodal Program for Cancer Related Cachexia Prevention	N/A
Not yet recruiting	`NCT06047054` - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting	`NCT05860556` - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting	`NCT04398836` - Preoperative Nutrition for Crohn's Disease Patients	Phase 3
Not yet recruiting	`NCT04183075` - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture	N/A
Not yet recruiting	`NCT03150927` - Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children	N/A
Recruiting	`NCT02833740` - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition	N/A
Recruiting	`NCT03408067` - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients	N/A
Completed	`NCT02938234` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake	N/A
Completed	`NCT02938247` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms