Mild Cognitive ImpairmentNeuroExerciseNCT02913053
The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment
A study testing Aerobic exercise and Non-aerobic exercise in people with Mild Cognitive Impairment, run by Radboud University Medical Center at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Aerobic exercise and Non-aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) according to the Albert et al (2011) criteria
- Montreal Cognitive Assessment (MoCA) (Nasreddine et al. 2005) score 18-26
- Stable medical condition for more than 6 months
- Stable medications for more than 3 months
- Adequate visual and auditory acuity to complete neuropsychological testin
- Electrocardiogram without significant abnormalities that might interfere with the study
Show all 10Show fewer
- Physical ability sufficient to allow performance of endurance exercise training
- Capacity to provide written and dated informed consent form
- Medical clearance to undergo a symptom-limited cardiopulmonary exercise test and extensive aerobic exercise training
- Participants recruited from the community via newspaper articles and community advertisement will complete additional testing to determine MCI status. Participants must score ≤1.5 standard deviation (SD) of cut-off scores on episodic memory test
Who cannot join
- Diagnosis of AD or other type of dementia
- History of familial early-onset dementia
- Enrollment onto any investigational drug study
- History in the past 2 years of epileptic seizures (Participants with epilepsy who have been stable off medication and seizure free for 2 years may be included)
- Any major psychiatric disorder (a clinical diagnosis of major depressive disorder, bipolar or schizophrenia)
- Past history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder
Show all 16Show fewer
- Carotid stent or severe stenosis
- History of myocardial infarction within previous year congestive heart failure (New York Heart Association Class II, III or IV)
- Uncontrolled hypertension or hypotension (systolic blood pressure >200 mm Hg and/or diastolic blood pressure >110 mm Hg at rest)
- Unstable cardiac, renal, lung, liver, or other severe chronic disease
- Type 2 diabetes mellitus with hypoglycemia in the last 3 months
- Significant history of alcoholism or drug abuse within last 10 years
- Significant obesity limiting active participation in the exercise program
- Engagement in moderate-intensity aerobic exercise training for more than 30 minutes, 3 times per week, during past 2 years
- History of vitamin B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed)
- Serious or non-healing wound, ulcer, or bone fracture
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment (MCI)
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.
Read the detailed description
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).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Aerobic exercise, Non-aerobic exercise
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Patients with mild cognitive impairment will undergo a one-year aerobic exercise program of 3 units of 45 min / week
Non-aerobic exerciseBehavioural
Patients with mild cognitive impairment will undergo a one-year stretching and toning (non-aerobic) exercise program of 3 units of 45 min / week
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Active comparator | Not described Receives: Behavioral: Aerobic exercise |
| Stretching and Toning | Active comparator | Not described Receives: Behavioral: Non-aerobic exercise |
| Usual care: Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Cognitive performance will be assessed by an extensive neuropsychological test battery
Measured: One year
Secondary outcomes (11)
Global cognitive function
MoCA (Montreal Cognitive Assessment)
Measured: One year
Cardiovascular fitness
(sub)maximal ergometer exercise test
Measured: One year
Physical activity
Activity monitoring with accelerometers
Measured: One year
Health related Quality of Life
Health Related Quality of Life for People with Dementia (DemQOL)
Measured: One year
Depressive symptoms
Center for Epidemiologic Studies Depression (CES-D)
Measured: One year
Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
Personality traits assessment
Measured: One year
Timed up and Go (TUG)
Frailty measurement
Measured: One year
Hand grip strength
Frailty measurement
Measured: One year
30 second chair stand
Frailty measurement
Measured: One year
Epigenetics
Genotyping of the Apolipoprotein E (APOE) 4 allele in venous blood.
Measured: One year
Brain imaging
Magnetic Resonance Imaging (MRI) scan: brain structure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- German Sport University, Cologne, University of Dublin, Trinity College, University of Bonn, University Hospital, Bonn
- Responsible party
- Sponsor
- Investigators
- Stefan Schneider, Prof, Principal investigator, German Sport University, GermanyBrian Lawlor, Prof, Principal investigator, Trinity College Dublin, IrelandMarcel Olde Rikkert, Prof, Principal investigator, Radboud University, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913053
- Sponsor's protocol ID
- ZonMw733051044
- Other IDs
- BMBF 01ED1510A, JPND-2014-1
- Acronym
- NeuroExercise
- Status last verified
- Nov 2019
- First submitted
- 17 Aug 2016
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Stuckenschneider T, Sanders ML, Devenney KE, Aaronson JA, Abeln V, Claassen JAHR, Guinan E, Lawlor B, Meeusen R, Montag C, Olde Rikkert MGM, Polidori MC, Reuter M, Schulz RJ, Vogt T, Weber B, Kessels RPC, Schneider S. NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. Front Aging Neurosci. 2021 Jan 14;12:621947. doi: 10.3389/fnagi.2020.621947. eCollection 2020.
PubMed 33519425Devenney KE, Sanders ML, Lawlor B, Olde Rikkert MGM, Schneider S; NeuroExercise Study Group. The effects of an extensive exercise programme on the progression of Mild Cognitive Impairment (MCI): study protocol for a randomised controlled trial. BMC Geriatr. 2017 Mar 22;17(1):75. doi: 10.1186/s12877-017-0457-9.
PubMed 28330458
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT02913053
- Acronym / sponsor ID
- NeuroExercise / ZonMw733051044
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- German Sport University, Cologne, University of Dublin, Trinity College, University of Bonn, University Hospital, Bonn
- Study start
- Jun 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Active comparator | Behavioral: Aerobic exercise |
| Stretching and Toning | Active comparator | Behavioral: Non-aerobic exercise |
| Usual care: Control Group | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) according to the Albert et al (2011) criteria
- Montreal Cognitive Assessment (MoCA) (Nasreddine et al. 2005) score 18-26
- Stable medical condition for more than 6 months
- Stable medications for more than 3 months
- Adequate visual and auditory acuity to complete neuropsychological testin
Key exclusion criteria (16 listed)
- Diagnosis of AD or other type of dementia
- History of familial early-onset dementia
- Enrollment onto any investigational drug study
- History in the past 2 years of epileptic seizures (Participants with epilepsy who have been stable off medication and seizure free for 2 years may be included)
- Any major psychiatric disorder (a clinical diagnosis of major depressive disorder, bipolar or schizophrenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercisePatients with mild cognitive impairment will undergo a one-year aerobic exercise program of 3 units of 45 min / week | Behavioural | Aerobic exercise |
| Non-aerobic exercisePatients with mild cognitive impairment will undergo a one-year stretching and toning (non-aerobic) exercise program of 3 units of 45 min / week | Behavioural | Stretching and Toning |
Primary outcome
Cognitive performance
Time frame: One year
Cognitive performance will be assessed by an extensive neuropsychological test battery
11 secondary outcomes
Global cognitive function
Time frame: One year
Cardiovascular fitness
Time frame: One year
Physical activity
Time frame: One year
Health related Quality of Life
Time frame: One year
Depressive symptoms
Time frame: One year
Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
Time frame: One year
Timed up and Go (TUG)
Time frame: One year
Hand grip strength
Time frame: One year
30 second chair stand
Time frame: One year
Epigenetics
Time frame: One year
Brain imaging
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Derived from this study: PubMed 33519425Stuckenschneider T, Sanders ML, Devenney KE, Aaronson JA, Abeln V, Claassen JAHR, Guinan E, Lawlor B, Meeusen R, Montag C, Olde Rikkert MGM, Polidori MC, Reuter M, Schulz RJ, Vogt T, Weber B, Kessels RPC, Schneider S. NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. Front Aging Neurosci. 2021 Jan 14;12:621947. doi: 10.3389/fnagi.2020.621947. eCollection 2020.
- Derived from this study: PubMed 28330458Devenney KE, Sanders ML, Lawlor B, Olde Rikkert MGM, Schneider S; NeuroExercise Study Group. The effects of an extensive exercise programme on the progression of Mild Cognitive Impairment (MCI): study protocol for a randomised controlled trial. BMC Geriatr. 2017 Mar 22;17(1):75. doi: 10.1186/s12877-017-0457-9.
- Individual participant dataSharing planned: Undecided
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Schneider, Prof principal investigator
German Sport University, Germany
Brian Lawlor, Prof principal investigator
Trinity College Dublin, Ireland
Marcel Olde Rikkert, Prof principal investigator
Radboud University, Netherlands
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Non-aerobic exercise in people with Mild Cognitive Impairment, run by Radboud University Medical Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Ireland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.