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

November 13, 2019 updated by: Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany
        • German Sport University
  • Ireland
      • Dublin, Ireland
        • Trinity College Dublin
  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aerobic exercise
Behavioral: Aerobic exercise
Patients with mild cognitive impairment will undergo a one-year aerobic exercise program of 3 units of 45 min / week
Active Comparator: Stretching and Toning
Behavioral: Non-aerobic exercise
Patients with mild cognitive impairment will undergo a one-year stretching and toning (non-aerobic) exercise program of 3 units of 45 min / week
No Intervention: Usual care: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive performance
Time Frame: One year
Cognitive performance will be assessed by an extensive neuropsychological test battery
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global cognitive function
Time Frame: One year
MoCA (Montreal Cognitive Assessment)
One year
Cardiovascular fitness
Time Frame: One year
(sub)maximal ergometer exercise test
One year
Physical activity
Time Frame: One year
Activity monitoring with accelerometers
One year
Health related Quality of Life
Time Frame: One year
Health Related Quality of Life for People with Dementia (DemQOL)
One year
Depressive symptoms
Time Frame: One year
Center for Epidemiologic Studies Depression (CES-D)
One year
Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
Time Frame: One year
Personality traits assessment
One year
Timed up and Go (TUG)
Time Frame: One year
Frailty measurement
One year
Hand grip strength
Time Frame: One year
Frailty measurement
One year
30 second chair stand
Time Frame: One year
Frailty measurement
One year
Epigenetics
Time Frame: One year
Genotyping of the Apolipoprotein E (APOE) 4 allele in venous blood.
One year
Brain imaging
Time Frame: 6 months
Magnetic Resonance Imaging (MRI) scan: brain structure
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

University Hospital, Bonn
University of Dublin, Trinity College
German Sport University, Cologne
University of Bonn

Investigators

  • Principal Investigator: Stefan Schneider, Prof, German Sport University, Germany
  • Principal Investigator: Brian Lawlor, Prof, Trinity College Dublin, Ireland
  • Principal Investigator: Marcel Olde Rikkert, Prof, Radboud University, Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZonMw733051044
  • BMBF 01ED1510A (Other Grant/Funding Number: German Sport University)
  • JPND-2014-1 (Other Grant/Funding Number: Trinity College Dublin)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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