Condition category
Mental and Behavioural Disorders
Date applied
25/05/2005
Date assigned
04/07/2005
Last edited
07/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marijke Jeanette Maidy Chin A Paw

ORCID ID

Contact details

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448203
m.chinapaw@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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).

Ethics approval

The study protocol was approved by the VU University Medical Center Medical Ethics Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mild cognitive impairment (MCI)

Intervention

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.

Intervention type

Supplement

Phase

Not Specified

Drug names

Folic Acid, vitamin B12 and B6 supplementation

Primary outcome measures

Cognitive functioning.

Secondary outcome measures

1. Psychosocial health status
2. Physical activity
3. Physical fitness
4. Serum homocysteine levels

Overall trial start date

01/09/2002

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

185

Participant exclusion criteria

1. Diseases interfering with cognition
2. Unable to participate in moderate-intensity physical activity

Recruitment start date

01/09/2002

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Research Center on Physical Activity, Work and Health (The Netherlands)

Sponsor details

TNO-VUmc - Body@Work
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8206
i.vanderleden@vumc.nl

Sponsor type

Research organisation

Website

http://www.bodyatwork.nl/

Funders

Funder type

Research organisation

Funder name

Body@Work (The Netherlands) - Research Center Physical Activity, Work and Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Netherlands Organisation for Applied Scientific Research (TNO) (The Netherlands) -VU University Medical Center (VUMC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fund for the Heart (Fonds voor het Hart) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Viatris B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Municipality of Alkmaar (Gemeente Alkmaar) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16375760
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18308888

Publication citations

  1. Protocol

    van Uffelen JG, Hopman-Rock M, Chin A Paw MJ, van Mechelen W, Protocol for Project FACT: a randomised controlled trial on the effect of a walking program and vitamin B supplementation on the rate of cognitive decline and psychosocial wellbeing in older adults with mild cognitive impairment [ISRCTN19227688]., BMC Geriatr, 2005, 5, 18, doi: 10.1186/1471-2318-5-18.

  2. Results

    van Uffelen JG, Chinapaw MJ, van Mechelen W, Hopman-Rock M, Walking or vitamin B for cognition in older adults with mild cognitive impairment? A randomised controlled trial., Br J Sports Med, 2008, 42, 5, 344-351, doi: 10.1136/bjsm.2007.044735.

Additional files

Editorial Notes