Folate Activity Cognition Trial
| ISRCTN | ISRCTN19227688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19227688 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/05/2005
- Registration date
- 04/07/2005
- Last edited
- 07/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marijke Jeanette Maidy Chin A Paw
Scientific
Scientific
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 4448203 |
|---|---|
| m.chinapaw@vumc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effects of physical activity and vitamin B supplementation on cognitive functioning and psychosocial health of older persons with mild cognitive impairment |
| Study acronym | FACT |
| Study objectives | 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(s) | The study protocol was approved by the VU University Medical Center Medical Ethics Committee. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Cognitive functioning. |
| Secondary outcome measures | 1. Psychosocial health status 2. Physical activity 3. Physical fitness 4. Serum homocysteine levels |
| Overall study start date | 01/09/2002 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 185 |
| Key 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 |
| Key exclusion criteria | 1. Diseases interfering with cognition 2. Unable to participate in moderate-intensity physical activity |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
Research Center on Physical Activity, Work and Health (The Netherlands)
Research organisation
Research organisation
TNO-VUmc - Body@Work
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8206 |
|---|---|
| i.vanderleden@vumc.nl | |
| Website | http://www.bodyatwork.nl/ |
Funders
Funder type
Research organisation
Body@Work (The Netherlands) - Research Center Physical Activity, Work and Health
No information available
The Netherlands Organisation for Applied Scientific Research (TNO) (The Netherlands) -VU University Medical Center (VUMC)
No information available
Fund for the Heart (Fonds voor het Hart) (The Netherlands)
No information available
Viatris B.V. (The Netherlands)
No information available
Municipality of Alkmaar (Gemeente Alkmaar) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 23/12/2005 | Yes | No | |
| Results article | Results | 01/05/2008 | Yes | No |
