An interventional study of Aerobic exercise and Non-aerobic exercise in Mild Cognitive Impairment, sponsored by Radboud University Medical Center. Completed at 3 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Prevention
Exercise interventions to prevent dementia and delay cognitive decline have gained considerable attention in recent years. Human and animal studies have demonstrated that regular physical activity targets brain function by increasing cognitive reserve. Although initial studies indicate enhanced cognitive performance in patients with mild cognitive impairment (MCI) following an exercise intervention, little is known about the effect of an extensive, controlled and regular exercise regimen on the neuropathology of patients with MCI.
The aim of this study is to compare a 12- month aerobic exercise programme versus a stretching and toning (non-aerobic) programme versus a control group on the progression of cognitive decline in MCI.
It is hypothesized that MCI-related decreases in cognitive and psychomotor functioning will show less progression or even be improved after a one-year aerobic exercise intervention compared to a group of patients undergoing stretching and toning exercise as well as to a control group provided with no intervention.
This randomised controlled clinical intervention study will take place across three European sites; the German Sport University Cologne, Germany, University of Nijmegen, The Netherlands and Trinity College Dublin, Ireland. Seventy-five previously sedentary patients with a clinical diagnosis of MCI will be recruited at each site. Participants will be randomised to one of three intervention arms. One group will receive a standardised one-year extensive aerobic exercise intervention (3 units of 45min / week). The second group will complete stretching and toning (non-aerobic) exercise (3 units of 45min / week) and the third group will receive usual care. Change in all outcomes will be measured at baseline (T0), after six months (T1) and after 12 months (T2).
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's enrollment of 183 is above the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Aerobic exercise
Behavioral: Non-aerobic exercise
Patients with mild cognitive impairment will undergo a one-year aerobic exercise program of 3 units of 45 min / week
Patients with mild cognitive impairment will undergo a one-year stretching and toning (non-aerobic) exercise program of 3 units of 45 min / week
Cognitive performance
Cognitive performance will be assessed by an extensive neuropsychological test battery
Time frame: One year
Global cognitive function
MoCA (Montreal Cognitive Assessment)
Time frame: One year
Cardiovascular fitness
(sub)maximal ergometer exercise test
Time frame: One year
Physical activity
Activity monitoring with accelerometers
Time frame: One year
Health related Quality of Life
Health Related Quality of Life for People with Dementia (DemQOL)
Time frame: One year
Depressive symptoms
Center for Epidemiologic Studies Depression (CES-D)
Time frame: One year
Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
Personality traits assessment
Time frame: One year
Timed up and Go (TUG)
Frailty measurement
Time frame: One year
Hand grip strength
Frailty measurement
Time frame: One year
30 second chair stand
Frailty measurement
Time frame: One year
Epigenetics
Genotyping of the Apolipoprotein E (APOE) 4 allele in venous blood.
Time frame: One year
Brain imaging
Magnetic Resonance Imaging (MRI) scan: brain structure
Time frame: 6 months
Plan to share: Undecided
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radboud University Medical Center →