Rationale:A study reporting the frailty trajectories after vascular surgery is currently lacking. The aim of this study is to evaluate the influence of the surgical intervention on the different domains of frailty, by measuring the characteristics…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
- Changes in frailty (according to the GFI)
Secondary outcome
Secondary outcomes:
Changes in:
- Handgrip strength
- Cognitive functioning (according to the MOCA)
- Body composition (BIA)
- Gait speed (4MWT)
- Body weight
Background summary
Almost 40% of the people aged between 65 and 74 are suffering from chronic
diseases and multi-morbidity is present in 60% of the people aged over 75
years. Multi-morbidity or chronological age does not seem the best method to
distinguish a physical frail patient from a fit patient because elderly people
have to cope with many conditions during the last stages of their life and can
suffer from handicaps and disabilities. All these conditions can lead to poor
outcomes after surgery or hospitalization, such as functional decline,
complications and nursing home placement. Frailty is a multidimensional
geriatric syndrome which is frequently used to describe the most vulnerable or
weakest older adults. According to Fried et al., the frailty phenotype model is
characterized by accumulation of slowness, weakness, weight loss, low physical
activity, and exhaustion. A different but increasingly important approach on
frailty includes cognitive impairment.
Over the past years, various frailty measurements, containing all the domains
of frailty, have been developed. However, the different domains of frailty can
also be determined separately. Slowness for example is measured by a
short-distance gait speed test, weakness by handgrip strength and the other
domains (including cognitive impairment) by a questionnaire.
In vascular surgery patients, attention for frailty is particularly important,
given that the population consists primarily of older adults with
multi-morbidity and prevalent physical disabilities. Studies have already shown
that frailty in the vascular surgical ward is common and it predicts poor
surgical outcome after various vascular surgery interventions.
In most of the studies, frailty has been assessed at one specific time-point,
assuming that frailty is a static state, even though researchers are also
looking at a different perspective on frailty and approaching it more as a
dynamic process that can be influenced by various factors. Moreover,
researchers found that patients who underwent surgery in the year before their
death had more hospital admissions, longer duration of stay and a greater
number of days spent in intensive care than those who did not have a surgical
procedure in the year before death. This finding could suggest that in the last
years of frail patients, intervening surgically is not automatically beneficial
to the frail state of the patient.
Study objective
Rationale:
A study reporting the frailty trajectories after vascular surgery is currently
lacking. The aim of this study is to evaluate the influence of the surgical
intervention on the different domains of frailty, by measuring the
characteristics of the frailty phenotype (i.e. slowness, weakness, weight loss,
low physical activity, and exhaustion) and the cognition of the patients
multiple times before and after the intervention.
Main study objective:
How do the cognitive and physical trajectories of frailty change in vascular
surgery patients in the first six months after the vascular surgery
intervention?
Study design
During the pre-operative screening at the outpatient vascular surgery clinic,
eligible patients will be informed by their vascular surgeon and asked to
participate in this study. If they are interested, they will be sent to one of
our researchers at the outpatient clinic who will provide more information
about the study. If they decide immediately to participate in the study, they
could sign the informed consent. If they wish to think longer about the
decision, they have the time until the preoperative (POPA) screening to sign
the informed consent. If the informed consent is obtained, patients will be
included. After inclusion, at the outpatient clinic or POPA, we will determine
the frailty state (according to the Groningen Frailty Indicator (GFI)) and
cognitive functioning of the patients (using the Montreal Cognitive Assessment
(MOCA)). Additionally handgrip strength, gait speed (according to the
4-meter-walk test (4MWT)), body composition (using Bio Impedance Analysis
(BIA)) and body weight will be determined. At hospital admission, we will only
perform the tests, when the tests during the POPA are >6 weeks ago. All tests
will be repeated at discharge, and at the one and six month post-operative
outpatient visit.
Study burden and risks
Not applicable since the nature of the study.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Indication for elective vascular surgery
- Aged >= 65 years
- Physically capable to perform at least half of the tests
- Sufficient command of the Dutch language
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Patients undergoing arteriovenous access surgery, percutaneous transluminal
angioplasty interventions (including coil embolization), venous interventions
and minor amputations (forefoot amputation, digits and wound revisions).
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 |
---|---|
Other | 201800817 |
CCMO | NL69602.042.19 |