The InChianti Follow-Up Study
|First Received Date ICMJE||April 6, 2011|
|Last Updated Date||April 25, 2013|
|Start Date ICMJE||January 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01331512 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The InChianti Follow-Up Study|
|Official Title ICMJE||The InChianti Follow-Up Study|
- Older persons are often referred to physicians because of mobility difficulties that grow worse as they age. To better understand the reasons for mobility difficulties in older persons, researchers conducted a population-based study of individuals living in the Chianti geographic area of Tuscany, Italy. Researchers are now interested in conducting a follow-up study on the original participants to assess the effects of aging on their mobility.
- To conduct a follow-up study on the participants in the mobility study of older persons in the Greve in Chianti and Bagno a Ripoli areas near Florence, Italy.
- Original participants in the InChianti Mobility Study.
In the past decade epidemiologic and clinical studies have described the prevalence and incidence of disability and have elucidated demographic characteristics, health behaviors, diseases, and physiologic impairments that are associated with increased risk of developing disability in old age. Mobility disability has emerged as a critical aspect of functioning. Mobility, defined as the ability to move independently from one point to another, is a critical part of maintaining independence and an essential attribute of quality of life. In those age 85 years and older, nearly 60 percent of women and 40 percent of men have difficulty walking two to three blocks. Older people who are mobile are more likely to remain in the community, have lower rates of subsequent morbidity and mortality, and have higher quality of life. Recent work in biomechanics, clinical geriatrics, epidemiology, and clinical trials has helped to improve our understanding of the decline in walking ability in old age and the influence of multiple intrinsic and extrinsic factors. However, a great deal is still not understood about how older persons progressively lose the ability to ambulate. The InChianti Study has the potential to make major new advances in our knowledge of progressive decline in ambulation in older persons.
A great deal of information is available from the baseline evaluation in this study and the crosssectional analyses that can be done with these data will be very valuable. There are, however, limitations in what we can learn from cross-sectional data. The baseline data revealed many relationships between factors that were studied and disability, but there may be circularity in these relationships that cannot be sorted out if we only have cross-sectional data available. For example, abnormalities in certain biomarkers may be a cause of disability or may be caused by disability. Only by doing longitudinal analyses that begin with non-disabled persons can the temporal sequence be determined. Cross-sectional analyses only permit the study of factors that are currently related to disability while longitudinal analyses allow for the identification of subclinical markers of risk that predict future disability onset. There is therefore much to be gained by performing a follow-up evaluation of the cohort to obtain longitudinal data.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||1200|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age 65 years and older
Must reside in Greve in Chianti or Bagno A Ripoli, Italy
Subjects with modertative cognitive problems will be included as long as the consent can be read and signed by by a first-degree relative of the participant or, in absence of first-degree relative, another relative living with or close to the participant
|Ages||65 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Italy|
|NCT Number ICMJE||NCT01331512|
|Other Study ID Numbers ICMJE||999903320, 03-AG-N320|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )|
|Study Sponsor ICMJE||National Institute on Aging (NIA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP