The primary objective of this study is to determine the nutritional intake, nutritional status, and physical activity level at various moments post-lower limb amputation (i.e., during hospital admission for amputation, at 5 weeks post-amputation, at…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are: nutritional intake, nutritional status, and physical
activity level during admission for amputation, and 5 weeks, 6 months and 9
months post amputation.
Secondary outcome
The association between nutritional intake and physical activity, and
nutritional status.
The association between nutritional intake, nutritional status, and physical
activity, and clinical outcomes (mortality rate, wound healing, quality of
life, physical function).
Background summary
People requiring a major dysvascular lower limb amputation are at high risk for
adverse clinical outcomes. Undernutrition and low physical activity level may
affect clinical outcomes negatively. However, little information is known about
the nutritional intake, nutritional status and physical activity level in the
amputation population, and their association with clinical outcomes.
Study objective
The primary objective of this study is to determine the nutritional intake,
nutritional status, and physical activity level at various moments post-lower
limb amputation (i.e., during hospital admission for amputation, at 5 weeks
post-amputation, at 6 months post-amputation, at 9 months post-amputation).
The other objectives are: to determine
- the association between nutritional intake and physical activity, and
nutritional status.
- the association between nutritional intake, nutritional status and physical
activity level, and clinical outcomes (mortality, wound healing, quality of
life, physical function).
Study design
Longitudinal observational study
Study burden and risks
Patients will receive usual care and the additional study measurements are not
psychological or physical demanding. Therefore, participation in this study
will not lead to increased risks. The physical function measurements are lower
in intensity as the usual care inpatient rehabilitation treatment. Next to
this, wearing an accelerometer does not limit the participants* functioning. We
will act upon case findings regarding undernutrition. If the participant is
diagnosed as undernourished, the patient will be advised to consult a
dietitian.
The main burden is the time investment of the participant. We will limit this
as much as possible, by scheduling the measurement moments right before or
after usual care visits at the rehabilitation center. Alternatively, the
investigator will visit the participant at home or any other location preferred
by the participant. Therefore, no extra hospital visits are required.
Furthermore, we will compensate for the time investment of the participants by
providing a gift card for every study measurement.
The benefits outweigh the time burden to the participant, as the information
obtained from this study will be used to improve nutritional care with the goal
to improve clinical outcomes in the amputation population.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Undergoing or recently (i.e., within seven weeks) having undergone a major
dysvascular lower limb amputation (i.e., Syme amputation or more proximal
level), being 18 years or older, and being able to collaborate.
Exclusion criteria
Requiring re-amputation, current cancer diagnosis, or having a severe
malabsorption disease.
Design
Recruitment
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 | NCT05747066 |
| CCMO | NL81994.042.22 |