The InChianti Follow-Up Study

Aging Clinical Trial

Official title:

The InChianti Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331512
• Other study ID #: 999903320
• Secondary ID: 03-AG-N320
• Status: Completed
• First received: April 6, 2011
• Last updated: April 4, 2018
• Start date: January 31, 2003
• Est. completion date: January 2, 2015

Study information

• Verified date: January 2, 2015
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

• 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.

Objectives:

• 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.

Eligibility:

• Original participants in the InChianti Mobility Study.

Design:

• The InChianti Follow-up Study will repeat most elements of the baseline evaluation from the original study. Participants will be seen on the 3-year anniversary of their baseline study assessment.

• Participants will have a home interview with questions about their physical and mental health, family history, daily activities, and living conditions related to their continued mobility.

• Participants will provide blood and urine samples, and will have tests of heart and motor nerve function and imaging studies of bones and the circulatory system.

• Participants will also have a functional evaluation of their motor skills, including walking tests, range of motion tests, and grip strength.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1167
• Est. completion date: January 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

• INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

Children

Related Conditions & MeSH terms

• Aging
• Decrease in Ambulation

Locations

Country	Name	City	State
Italy	National Institute of Research and Care on Aging	Florence

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

Italy,