The aim of this research project is to investigate whether time-related trajectories of intrinsic capacity can predict maintenance of robustness (healthy ageing) or the onset of frailty in persons aged 55 to 75 over a period of 10 years. In the long…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Kwetsbaarheid (zie s.v.p. paragraaf 6.1.1 (Primary endpoints) voor de definitie.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Variables: Factors related to trajectories of intrinsic capacity covering 7
physiological systems. Please see sections 6.1.2.1 to 6.1.2.7 of the research
protocol for a desription of the physiological systems, the factors and the
measurements.
Primary outcome: Staying robust or the occurence of frailty when positive on at
least one of three instruments (Fried Phenotype, Rockwood Frailty Index,
Groningen Frailty Indicator). Please see section 6.1.1 of the research protocol
for a description of these instruments for measuring frailty.
Secondary outcome
Additional explanatory variables: Factors related to functional ability and/or
(neuro)physiological factors that can explain changes in trajectories of
intrinsic capacity. Please see sections 6.1.3.1 to 6.1.3.6 of the research
protocol for descriptions of these variables and their measurements.
Background summary
It is a well-known fact that the world population is ageing. This demographic
shift brings along many health challenges. One of the ways to overcome these
challenges is to promote healthy ageing. The World Health Organisation (WHO)
considers Heathy Ageing in a holistic sense, one that is based on life-course
and functional perspectives (WHO 2015). Hence, health is considered from the
perspective of an adult*s longitudinal trajectory of intrinsic capacity and
functional ability. However, frailty is the ultimate obstacle hindering healthy
ageing. Predictive models of future trajectories of functional decline and
healthy aging could provide the opportunity to intervene in specific ways to
counter frailty and to promote Healthy Ageing.
Study objective
The aim of this research project is to investigate whether time-related
trajectories of intrinsic capacity can predict maintenance of robustness
(healthy ageing) or the onset of frailty in persons aged 55 to 75 over a period
of 10 years. In the long term, the results of this project will allow
(clinicians, policy makers) to differentiate proactively those persons who will
remain fit and independent from those who are apparently fit but who are at
risk of becoming frail.
Study design
Prospective cohort study with reassessment every 2.5 years for a total
follow-up of 10-years.
Study burden and risks
Based on our previous experiences from a similar research, we estimate the
medical screening by the physician, the filling out of the questionnaires and
the physical measurements to last approximately 3 hours. These measurements
take place every 2.5 years, in total 4 times over a period of 10 years. The
questionnaires will be filled in every year (30 minutes). The medical screening
only takes place at baseline.
To our knowledge, the literature does not indicate that risks are associated
with the measurements. A venepuncture can sometimes be accompanied by a
sensation of inconvenience and/or a small hematoma. The irradiation related to
a DXA scan is extremely low (corresponding to a few days walking in open air).
Exercise tolerance tests and muscle performance tests can give rise to feelings
of tiredness and muscle soreness.
Softwareweg 5
Amersfoort 3821 BN
NL
Softwareweg 5
Amersfoort 3821 BN
NL
Listed location countries
Age
Inclusion criteria
Subjects aged between 55 and 75 years, who are living independently in the city
of Amersfoort (the Netherlands) and who understand spoken and written are
eligible to participate. All participants will provide written informed
consent. After signing informed consent, each participant will first undergo a
medical screening by a physician in order to exclude any contra-indications for
participation to the test battery. Those who are non-frail at baseline (i.e.
robust on three frailty scales: score=0/5 for the Fried phenotype, score<0.25
for the Rockwood Frailty Index as operationalised by Collerton et al. and
score<4/15 for the Groningen Frailty Indicator) will be included in the
longitudinal study and invited to be reassessed for potential early markers of
frailty every 2.5 years for 10 years.
Exclusion criteria
Subjects who are at baseline unable to participate in the assessments due to
physical (e.g. unable to stand up or walk) or cognitive impairments (e.g.
unable to understand the test instructions and/or Mini Mental State Examination
score < 23/30), will be excluded as well as those with a recent (past 6 months)
diagnosis of cancer and/or who had surgery, chemotherapy or radiotherapy within
the past 6 months or scheduled for the near future.
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 |
|---|---|
| CCMO | NL70141.096.19 |