|- candidate number||7899|
|- NTR Number||NTR2269|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mrt-2010|
|- Secondary IDs||NL32037.000.10 ABR nr.|
|- Public Title||Healthy Aging and Dementia.|
|- Scientific Title||Healthy Aging: aerobic exercise, strength training and dementia.|
|- hypothesis||Older 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) studied||Cognition, Daily functioning, Physical functioning, Social functioning|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-sep-2014|
|- Target number of participants||153|
|- Interventions||The 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.
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 consists of walking. Walks will be performed for 30 minutes per session and, if necessary, moments of rest will be included.
The control group will receive social visits with the same frequency and duration as the combined exercise group and the aerobic exercise group.
|- Primary outcome||The differences between neuropsychological test battery scores between pre-, post-, and delayed post measurement are the main outcome parameters for this study.|
|- Secondary outcome||The differences between physical test performances and ADL questionnaires between pre-, post-, and delayed post measurement are the secondary outcome parameters for this study.|
|- Timepoints||1. Pre-measurement (T0);|
2. 10 weeks intervention;
3. Post-measurement (T1);
4. 10 weeks no intervention;
5. Delayed post-measurement (T2).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. W.J.R. Bossers|
|- CONTACT for SCIENTIFIC QUERIES||MSc. W.J.R. Bossers|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Title: |
Healthy Ageing: Aerobic exercise, strength training and dementia.
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.
The objective is to investigate the effects of a combined strength and aerobic exercise program on cognition, physical functioning, social functioning and ADL.
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.
The study population consists of older people with moderate to moderate severe dementia (MMSE 10-22) aged > 65 years of age.
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)|
|- RECORD||31-mrt-2010 - 19-nov-2010|