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Physical activity in early-onset dementia.


- candidate number6748
- NTR NumberNTR2124
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-nov-2009
- Secondary IDs2009/220 METc VUmc
- Public TitlePhysical activity in early-onset dementia.
- Scientific TitleExercise and cognition in sedentary adults with early-onset dementia (EXERCISE-ON).
- ACRONYMEXERCISE-ON: EXERcise and Cognition In Sedentary adults with Early-ONset dementia.
- hypothesisDevelopment of early-onset dementia (EOD) is very radical and disabling for both patient and family, due to the still prominent role of the patient in society. Except for knowledge on cognitive disorders not much is known about other disabling disorders in EOD. Several characteristics of EOD, like apathy and loss of initiative, could lead to motor inactivity which can lead to motor disability. Evidence is found on a strong association between physical aerobe activity and cognition in both people of middle age as in the elderly.

Researchquestion:
Three different exercise programs are offered to persons with early-onset dementia: Aerobe Activity Program; Non-aerobe Activity Program; Aerobe activity program at home. Which program is able to slow down the progressive course of the symptoms of dementia (regarding: cognition, instrumental activities of daily living, and quality of life)?

Hypothesis:
Given the positive effects found in animal studies, it is expected that the Aerobe Activity Program will show most beneficial effects on the symptoms of dementia in early-onset dementia.
- Healt Condition(s) or Problem(s) studiedSports, Presenile dementia, Early-onset dementia, Presenile Alzheimer's disease, Frontotemporal dementia, Vascular dementia, Lewy-body dementia
- Inclusion criteria1. Diagnosis of early-onset dementia (onset of complaints < 66 years) (among others: Alzheimer's disease, Vascular dementia, Frontotemporal dementia);
2. Relatively early stage of dementia (MMSE > 15);
3. Primary caregiver available.
- Exclusion criteria1. Bound to a wheelchair;
2. Neurodegenerative diseases that primarily result in motor impairments, such as Parkinson's disease and Huntington's disease;
3. Cardiovascular problems, such as severe cardiac problems or servere hypertension;
4. Abuse of alcohol or other substances;
5. Trauma capitis in the medical history, in which a loss of consiousness was present of more than 15 minutes;
6. Extended history of psychiatry (major depression, bipolar disorder, psychosis);
7. Severe visual problems;
8. Severe auditive problems;
9. Insufficient mastery of the Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2009
- planned closingdate1-mrt-2012
- Target number of participants180
- Interventions1. Aerobe activity program:
a. Length: 3 months;
b. Frequency: 3 times a week;
c. Activity: primarily cycling on a cycle ergometer;
d. Setting: rehabilitation centre.
2. Flexibility program:
a. Length: 3 months;
b. Frequency: 3 times a week;
c. Activity: flexibility exercises and relaxation exercises;
d. Setting: rehabilitation centre.
3. Aerobe activity program at home:
a. Length: 3 months;
b. Frequency: 3 times a week;
c. Activity: primarily cycling;
d. Setting: at home.
- Primary outcome1. Global cognitive functioning: Alzheimer Disease Assessment Scale (ADAS)-COG;
2. Mental speed: Trailmaking test A (TMT A);
3. Executive functioning (flexibility): Trailmaking test B (TMT B);
4. Instrumental Activities of Daily Functioning: Disability Assessment for Dementia (DAD);
5. Quality of Life: Dementia-Quality of Life (D-QOL).
- Secondary outcome1. Physical functioning:
a. 6 minutes walk test;
b. Sit to stand test;
c. Physical Activity Scale for the Elderly (PASE).
2. Cognitive functioning:
a. Mini Mental State Examination (MMSE);
b. “Face recognition” and “Picture recognition” (subtest of the Rivermead Behavioural Memory Test (RBMT));
c. “Digit Span” (subtest of the Wechsler Memory Scale-Revised (WMS-R);
d. Fluency: category fluency and letter fluency;
e. Stroop colour word test;
f. “Symbol substitution” (subtest of the Wechsler Adult Intelligence Scale – III (WAIS-III));
g. “Number location” (subtest of the Visual Object and Space Perception Battery (VOSP));
h. “Visual closure” (subtest of the Groninger Intelligence Test (GIT)).
3. Questionnaires:
a. Dutch translation of the General Self-efficacy Scale;
b. Centre for Epidemiologic Studies Depression;
c. Rest-activty rhythm: actigraphy.
- Timepoints1. Baseline measurement, before intervention;
2. Measurement after the intervention, 3 months after baseline measurement;
3. Measurement 6 months after baseline measurement.
- Trial web sitewww.dementieinbeweging.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. A.M. Hooghiemstra
- CONTACT for SCIENTIFIC QUERIESMSc. A.M. Hooghiemstra
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Roomsch Catholijk Oude Armen Kantoor (RCOAK), Amsterdam, the Netherlands
- PublicationsN/A
- Brief summaryDevelopment of early-onset dementia (EOD) is very radical and disabling for both patient and family, due to the still prominent role of the patient in society. Except for knowledge on cognitive disorders not much is known about other disabling disorders in EOD. Several characteristics of EOD, like apathy and loss of initiative, could lead to motor inactivity which can lead to motor disability. Evidence is found on a strong association between physical aerobe activity and cognition in both people of middle age as in the elderly.
In our study three different exercise programs are offered to persons with early-onset dementia. We will investigate which program is able to slow down the progressive course of the symptoms of dementia.
- Main changes (audit trail)
- RECORD23-nov-2009 - 18-dec-2009


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