search
Back to results

The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment (NeuroExercise)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Aerobic exercise
Non-aerobic exercise
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • German Sport University
  • Trinity College Dublin
  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Aerobic exercise

Stretching and Toning

Usual care: Control Group

Arm Description

Outcomes

Primary Outcome Measures

Cognitive performance
Cognitive performance will be assessed by an extensive neuropsychological test battery

Secondary Outcome Measures

Global cognitive function
MoCA (Montreal Cognitive Assessment)
Cardiovascular fitness
(sub)maximal ergometer exercise test
Physical activity
Activity monitoring with accelerometers
Health related Quality of Life
Health Related Quality of Life for People with Dementia (DemQOL)
Depressive symptoms
Center for Epidemiologic Studies Depression (CES-D)
Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
Personality traits assessment
Timed up and Go (TUG)
Frailty measurement
Hand grip strength
Frailty measurement
30 second chair stand
Frailty measurement
Epigenetics
Genotyping of the Apolipoprotein E (APOE) 4 allele in venous blood.
Brain imaging
Magnetic Resonance Imaging (MRI) scan: brain structure

Full Information

First Posted
August 17, 2016
Last Updated
November 13, 2019
Sponsor
Radboud University Medical Center
Collaborators
German Sport University, Cologne, University of Dublin, Trinity College, University of Bonn, University Hospital, Bonn
search

1. Study Identification

Unique Protocol Identification Number
NCT02913053
Brief Title
The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment
Acronym
NeuroExercise
Official Title
The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment (MCI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
German Sport University, Cologne, University of Dublin, Trinity College, University of Bonn, University Hospital, Bonn

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Title
Stretching and Toning
Arm Type
Active Comparator
Arm Title
Usual care: Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Patients with mild cognitive impairment will undergo a one-year aerobic exercise program of 3 units of 45 min / week
Intervention Type
Behavioral
Intervention Name(s)
Non-aerobic exercise
Intervention Description
Patients with mild cognitive impairment will undergo a one-year stretching and toning (non-aerobic) exercise program of 3 units of 45 min / week
Primary Outcome Measure Information:
Title
Cognitive performance
Description
Cognitive performance will be assessed by an extensive neuropsychological test battery
Time Frame
One year
Secondary Outcome Measure Information:
Title
Global cognitive function
Description
MoCA (Montreal Cognitive Assessment)
Time Frame
One year
Title
Cardiovascular fitness
Description
(sub)maximal ergometer exercise test
Time Frame
One year
Title
Physical activity
Description
Activity monitoring with accelerometers
Time Frame
One year
Title
Health related Quality of Life
Description
Health Related Quality of Life for People with Dementia (DemQOL)
Time Frame
One year
Title
Depressive symptoms
Description
Center for Epidemiologic Studies Depression (CES-D)
Time Frame
One year
Title
Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
Description
Personality traits assessment
Time Frame
One year
Title
Timed up and Go (TUG)
Description
Frailty measurement
Time Frame
One year
Title
Hand grip strength
Description
Frailty measurement
Time Frame
One year
Title
30 second chair stand
Description
Frailty measurement
Time Frame
One year
Title
Epigenetics
Description
Genotyping of the Apolipoprotein E (APOE) 4 allele in venous blood.
Time Frame
One year
Title
Brain imaging
Description
Magnetic Resonance Imaging (MRI) scan: brain structure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Schneider, Prof
Organizational Affiliation
German Sport University, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Lawlor, Prof
Organizational Affiliation
Trinity College Dublin, Ireland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcel Olde Rikkert, Prof
Organizational Affiliation
Radboud University, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Sport University
City
Cologne
Country
Germany
Facility Name
Trinity College Dublin
City
Dublin
Country
Ireland
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33519425
Citation
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.
Results Reference
derived
PubMed Identifier
28330458
Citation
Devenney 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. Erratum In: BMC Geriatr. 2017 May 19;17 (1):112.
Results Reference
derived

Learn more about this trial

The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment

We'll reach out to this number within 24 hrs