search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Healthy Aging and Dementia.


- candidate number7899
- NTR NumberNTR2269
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mrt-2010
- Secondary IDsNL32037.000.10 ABR nr.
- Public TitleHealthy Aging and Dementia.
- Scientific TitleHealthy Aging: aerobic exercise, strength training and dementia.
- ACRONYMHAD
- hypothesisOlder people with dementia who participate in a combined aerobic and strength training program will show larger effects on cognition, physical functioning, ADL functioning and social functioning in comparison with older people with dementia who participate in an aerobic training program or a social visit group.
- Healt Condition(s) or Problem(s) studiedCognition, Daily functioning, Physical functioning, Social functioning
- Inclusion criteria1. To look if the participant is mobile, the Timed Up & Go Test is assessed. The participant is included If he/she is able to perform this test with or without assistive device;
2. To investigate if the participant is able to perform neuropsychological tests and if he/she fits the population criteria, a Mini Mental State Examination is assessed. The participant is included if he/she scores between 10 and 22.
- Exclusion criteria1. Wheelchair bound;
2. Have cardiovascular problems (e.a. severe high blood pressure or cardiac problems) that limit them from physical activity;
3. Have a history of alcoholism;
4. Have severe visual problems;
5. Have severe auditive problems;
6. Have problems with the Dutch language.

If the participant scores < 10 or > 22 on the MMSE or is not able to perform the Timed Up & Go Test he/she is excluded form the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate1-sep-2014
- Target number of participants153
- InterventionsThe supervised training programs will be offered for 30 minutes a day, 5 days a week, during 10 weeks. The combined strength and aerobic group will walk 3 days per week and perform exercises to increase leg strength for 2 days per week. The aerobic training group will walk 5 days per week. To control for social factors during the intervention, the control group will receive social visits with the same frequency and duration as the other groups. For all training programs, the participants will be guided individually by the PhD student or a well trained Master student Human Movement Sciences.

Strength training:
After a 5 minute walking warming-up period, 25 minutes of specific strength exercises will follow: Knee extensions (‘knee straightening’), plantar flexion ("toe standing"), hip abduction ("side lifts"), and hip extension ("back leg lifts").

Aerobic training:
Aerobic training consists of walking. Walks will be performed for 30 minutes per session and, if necessary, moments of rest will be included.

Social visits:
The control group will receive social visits with the same frequency and duration as the combined exercise group and the aerobic exercise group.
- Primary outcomeThe differences between neuropsychological test battery scores between pre-, post-, and delayed post measurement are the main outcome parameters for this study.
- Secondary outcomeThe differences between physical test performances and ADL questionnaires between pre-, post-, and delayed post measurement are the secondary outcome parameters for this study.
- Timepoints1. Pre-measurement (T0);
2. 10 weeks intervention;
3. Post-measurement (T1);
4. 10 weeks no intervention;
5. Delayed post-measurement (T2).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. W.J.R. Bossers
- CONTACT for SCIENTIFIC QUERIESMSc. W.J.R. Bossers
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryTitle:
Healthy Ageing: Aerobic exercise, strength training and dementia.

Rationale:
Dementia presents a major public health problem that impacts people’s ability to maintain cognitive, physical and social function. There are indications that physical activity can enhance cognition in older people with dementia. However, the number of studies is limited, the outcomes ambiguous and only studies with aerobic exercise programs were performed. This study focuses on the effects of combined strength and aerobic exercise in older people with dementia to evaluate the theory that there are stronger effects on cognition, physical functioning and ADL in comparison with an aerobic exercise program and controls.

Objective:
The objective is to investigate the effects of a combined strength and aerobic exercise program on cognition, physical functioning, social functioning and ADL.

Study design:
The study design is a randomized clinical trial. After pre-stratification on MMSE score, the participants will be randomized over three groups: combined strength and aerobic exercise, aerobic exercise only, control intervention (social visits). Measurements will take place, blinded for group, before the intervention (pretest), after the 10 weeks intervention (posttest) and at follow-up 10 weeks after the posttest.

Study population:
The study population consists of older people with moderate to moderate severe dementia (MMSE 10-22) aged > 65 years of age.

Intervention:
The intervention consists of a supervised physical exercise program which will be offered for 30 minutes a day, five days a week, during 10 weeks. The combined strength and aerobic group walk on 3 days per week and perform strength training on 2 days per week. The aerobic group will walk on 5 days per week. The controls receive social visits with the same frequency and duration.

Main study parameters/endpoints:
The main outcome parameters are cognition (memory and executive functioning), physical functioning, ADL and social functioning.
- Main changes (audit trail)
- RECORD31-mrt-2010 - 19-nov-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl