This project aims to improve physical performance in older patients, by offering a personalized combined nutritional intervention with a physical activity training program. The intervention starts at hospital admittance, and is continued after…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
sarcopenie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is based on the difference in change in physical
performance between baseline and after 3 months of intervention of the
intervention and the control group (usual care). This will be analyzed using
multilevel mixed model corrected by potential confounders, measured by the
Timed up & Go test (TUG), a sensitive tool to measure physical performance in
elderly.
Secondary outcome
As a secondary outcome, the effect on short physical performance battery,
muscle strength, muscle mass, nutritional status, movement, independence,
quality of life, clinical outcomes and cost-effectiveness will be studied.
Background summary
The older hospitalized population is growing and specifically at risk for
decreased muscle mass and physical functioning and has a negative influence on
activities of daily living, independence, quality of life, re-admissions, and
nursing home placement. Current knowledge shows that a physical activity
training programs consisting of tailored resistance and endurance exercise can
improve muscle mass in healthy elderly. Nutritional interventions in
conjunction with physical activity based on individual protein requirements,
high quality protein and timing of protein intake can further stimulate muscle
protein synthesis. The effect of a combined nutritional intervention with
physical activity in healthy individuals and athletes has been studied before,
but not in older hospitalized patients. A personalized combined physical
activity program and a nutritional intervention could be a solution and is an
exciting emerging field of research with the potential to dramatically improve
patient outcomes.
The average hospital admittance is 4 to 5 days in which the prevention of the
decline in muscle mass and physical performance can be initiated but not
improved. Thus, the translation of a prolonged combined intervention to home
care is essential. To support the combined personalized nutritional
intervention and physical exercise intervention during hospitalization and home
care, an eHealth application for and with older patients can be beneficial.
Study objective
This project aims to improve physical performance in older patients, by
offering a personalized combined nutritional intervention with a physical
activity training program. The intervention starts at hospital admittance, and
is continued after discharge in the home care setting, supported by an e-health
application.
Study design
The study will be performed as a randomized clinical trial.
Intervention
One group receives a personalized nutritional intervention by a dietician
combines with a functional training program by physical therapists. The
nutritional intervention focuses on adequate protein intake, type, and timing
of protein. The exercise program will make use of goal setting throughout the
intervention period to optimize the training effect . The control group will
receive usual care.
Study burden and risks
Study measurements are non-invasive. This study will not confer any no
additional risks. The intervention will start at hospital admittance and will
be continued after discharge in the home setting by a dietician and
physiotherapist in their nearby home, which keeps the burden for the patient
relatively low and is an extra service for the patient. Protein supplementation
will be delivered within the save amounts. Possible serious reactions to the
intervention will be noted as SAE*s.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Age >=65
Living within the Nijmegen area (within 40km of Radboudumc)
Admitted to clinical ward of Radboudumc or CWZ
Dutch speaking
Mentally competent
Exclusion criteria
Complete use of tube feeding or parenteral nutrition
Renal insufficiency (MDRD-GFR < 30ml/min)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05413616 |
| CCMO | NL80672.091.22 |