The InChianti Follow-Up Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT01331512
First received: April 6, 2011
Last updated: January 3, 2015
Last verified: January 2015
  Purpose

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.

Condition
Aging
Decrease in Ambulation

Study Type: Observational
Official Title: The InChianti Follow-Up Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1200
Study Start Date: January 2003
Estimated Study Completion Date: January 2015
Detailed 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331512

Locations
Italy
National Institute of Research and Care on Aging
Florence, Italy
Sponsors and Collaborators
Investigators
Principal Investigator: Tamara B Harris, M.D. National Institute on Aging (NIA)
  More Information

No publications provided by National Institutes of Health Clinical Center (CC)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Dashti HS, Follis JL, Smith CE, Tanaka T, Cade BE, Gottlieb DJ, Hruby A, Jacques PF, Lamon-Fava S, Richardson K, Saxena R, Scheer FA, Kovanen L, Bartz TM, Perälä MM, Jonsson A, Frazier-Wood AC, Kalafati IP, Mikkilä V, Partonen T, Lemaitre RN, Lahti J, Hernandez DG, Toft U, Johnson WC, Kanoni S, Raitakari OT, Perola M, Psaty BM, Ferrucci L, Grarup N, Highland HM, Rallidis L, Kähönen M, Havulinna AS, Siscovick DS, Räikkönen K, Jørgensen T, Rotter JI, Deloukas P, Viikari JS, Mozaffarian D, Linneberg A, Seppälä I, Hansen T, Salomaa V, Gharib SA, Eriksson JG, Bandinelli S, Pedersen O, Rich SS, Dedoussis G, Lehtimäki T, Ordovás JM. Habitual sleep duration is associated with BMI and macronutrient intake and may be modified by CLOCK genetic variants. Am J Clin Nutr. 2015 Jan;101(1):135-43. doi: 10.3945/ajcn.114.095026. Epub 2014 Nov 26.
Tanaka T, Ngwa JS, van Rooij FJ, Zillikens MC, Wojczynski MK, Frazier-Wood AC, Houston DK, Kanoni S, Lemaitre RN, Luan J, Mikkilä V, Renstrom F, Sonestedt E, Zhao JH, Chu AY, Qi L, Chasman DI, de Oliveira Otto MC, Dhurandhar EJ, Feitosa MF, Johansson I, Khaw KT, Lohman KK, Manichaikul A, McKeown NM, Mozaffarian D, Singleton A, Stirrups K, Viikari J, Ye Z, Bandinelli S, Barroso I, Deloukas P, Forouhi NG, Hofman A, Liu Y, Lyytikäinen LP, North KE, Dimitriou M, Hallmans G, Kähönen M, Langenberg C, Ordovas JM, Uitterlinden AG, Hu FB, Kalafati IP, Raitakari O, Franco OH, Johnson A, Emilsson V, Schrack JA, Semba RD, Siscovick DS, Arnett DK, Borecki IB, Franks PW, Kritchevsky SB, Lehtimäki T, Loos RJ, Orho-Melander M, Rotter JI, Wareham NJ, Witteman JC, Ferrucci L, Dedoussis G, Cupples LA, Nettleton JA. Genome-wide meta-analysis of observational studies shows common genetic variants associated with macronutrient intake. Am J Clin Nutr. 2013 Jun;97(6):1395-402. doi: 10.3945/ajcn.112.052183. Epub 2013 May 1.

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT01331512     History of Changes
Other Study ID Numbers: 999903320, 03-AG-N320
Study First Received: April 6, 2011
Last Updated: January 3, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Clinical Geriatrics
Biomechanics
Epidemiology
Decline in Ambulation

ClinicalTrials.gov processed this record on August 02, 2015