Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02690402 |
| Other study ID # |
15-PP-12 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 12, 2016 |
| Est. completion date |
January 24, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Older people are a very heterogeneous population characterized by a high interindividual
variability. Functional abilities (walking, transfers ...) used to classify individuals aged
(Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS,
2005). Frailty is generally considered as a state that precedes dependent status and, unlike
the latter, is still reversible (Fried et al., 2001). Now, it's necessary to understand and
quantify the indicators above the dependence of the elderly from a multidisciplinary approach
to frailty, is a critical public health issue for developing non-drug therapeutic
interventions adapted to delay the institutionalization. Through this study, it is to
identify risk and protective factors of frailty and their relationships with physical
activity, evaluate them and propose an appropriate care to the patient. This study should
enable the production of new scientific knowledge to improve the health and quality of life
of older people.
Description:
Older people are a very heterogeneous population characterized by a high interindividual
variability. Functional abilities (walking, transfers ...) used to classify individuals aged
(Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS,
2005). Frailty is generally considered as a state that precedes dependent status and, unlike
the latter, is still reversible (Fried et al., 2001). These authors proposed criteria:
physical inactivity (low levels of physical activity), unintentional weight loss (more than
5% of body weight over 6 months), perceived general fatigue, weakness of grip strength
(handgrip) and slow speed walk. Nevertheless, at present, other more objective evaluation
methods that include mobility, balance, muscle strength, endurance and cognition are
necessary. Furthermore, psychological characteristics have not been studied with frailty
indicators, except to walk speed. Now, these last are important levers of people adherence to
physical activity programs (Baert et al., 2011). In this sense, better understand and
quantify the indicators above the dependence of the elderly from a multidisciplinary approach
to frailty, is a critical public health issue for developing non-drug therapeutic
interventions adapted to delay the institutionalization.
The proposed study is to items (a) to characterize the functional dimensions of frailty from
objective indicators and (b) putting them in relation to the cognitive and psychosocial
characteristics of the elderly in order to define individual devices of care through physical
activity.
To meet these objectives, it is necessary to include a large number of people in a
comprehensive evaluation protocol physical, and their psycho-social and cognitive
characteristics.
The research will begin with an inclusive visit by a medical doctor. Evaluation begins with a
impedancemetric measurement, followed by posturographic evaluation. Then, in a first phase,
patients will perform walk tests (e.g., 6 minutes, 10 m) during which spatiotemporal
parameters of gait cycle, and the electromyographic activity of the different muscles of the
lower limbs will be quantified. After the walk test, each subject will receive an evaluation
of the strength of the ankle and knee muscles by an isokinetic dynamometer. During these
contractions, the surface electromyographic activity of patients will also be recorded. In a
second phase, subjects will perform a series of repetitions at 50% of maximum voluntary
contraction (MVC) on the isokinetic dynamometer, to measure strength endurance. Thirdly,
participants will be asked to complete cognitive tests and psychometric questionnaires.
Finally, a personalized care will be offered in terms of adapted physical activity. The
evaluation protocol will be performed again to measure the impact of physical activity three
months after the first assessment.
Through this assessment, it is to identify risk and protective factors of frailty and their
relationships with physical activity, evaluate them and propose an appropriate care to the
patient. This study should enable the production of new scientific knowledge to improve the
health and quality of life of older people.
