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Folate Activity Cognition Trial
ISRCTN ISRCTN19227688
DOI 10.1186/ISRCTN19227688
ClinicalTrials.gov identifier
EudraCT number
Public title Folate Activity Cognition Trial
Scientific title The effects of physical activity and vitamin B supplementation on cognitive functioning and psychosocial health of older persons with mild cognitive impairment
Acronym FACT
Serial number at source N/A
Study hypothesis The aim of the study is to examine the effects of a walking programme and/or Folic Acid/B12/B6 supplementation on cognitive functioning and psychosocial health of older persons with mild cognitive impairment (MCI).
Lay summary
Ethics approval The study protocol was approved by the VU University Medical Center Medical Ethics Committee.
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Mild cognitive impairment (MCI)
Participants - inclusion criteria 1. People aged 70 years or older
2. MCI according to the criteria of Petersen:
2.1. Memory complaint
2.2. Objective memory impairment
2.3. Normal general cognitive function
2.4. Intact activities of daily living
2.5. Not demented
3. Recruited from the community
Participants - exclusion criteria 1. Diseases interfering with cognition
2. Unable to participate in moderate-intensity physical activity
Anticipated start date 01/09/2002
Anticipated end date 30/09/2006
Status of trial Completed
Patient information material
Target number of participants 185
Interventions Twice weekly brisk walking in a group at moderate intensity and/or daily supplementation with Folic Acid, vitamin B12 and B6.

Non-supplement groups receive a placebo supplement; non-walking groups will do stretching and relaxation exercises.
Primary outcome measure(s) Cognitive functioning.
Secondary outcome measure(s) 1. Psychosocial health status
2. Physical activity
3. Physical fitness
4. Serum homocysteine levels
Sources of funding 1. Body@Work (The Netherlands) - Research Center Physical Activity, Work and Health
2. The Netherlands Organisation for Applied Scientific Research (TNO) (The Netherlands) -VU University Medical Center (VUMC)
3. Fund for the Heart (Fonds voor het Hart) (The Netherlands)
4. Viatris B.V. (The Netherlands)
5. Municipality of Alkmaar (Gemeente Alkmaar) (The Netherlands)
Trial website
Publications 1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16375760
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18308888
Contact name Dr  Marijke Jeanette Maidy  Chin A Paw
  Address van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 4448203
  Fax +31 (0)20 4448387
  Email m.chinapaw@vumc.nl
Sponsor Research Center on Physical Activity, Work and Health (The Netherlands)
  Address TNO-VUmc - Body@Work
van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 444 8206
  Fax +31 (0)20 444 8387
  Email i.vanderleden@vumc.nl
  Sponsor website: http://www.bodyatwork.nl/
Date applied 25/05/2005
Last edited 07/03/2008
Date ISRCTN assigned 04/07/2005
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