NCT02913053

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

3.4 years

First QC Date

August 17, 2016

Last Update Submit

November 13, 2019

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    Cognitive performance will be assessed by an extensive neuropsychological test battery

    One year

Secondary Outcomes (11)

  • Global cognitive function

    One year

  • Cardiovascular fitness

    One year

  • Physical activity

    One year

  • Health related Quality of Life

    One year

  • Depressive symptoms

    One year

  • +6 more secondary outcomes

Study Arms (3)

Aerobic exercise

ACTIVE COMPARATOR
Behavioral: Aerobic exercise

Stretching and Toning

ACTIVE COMPARATOR
Behavioral: Non-aerobic exercise

Usual care: Control Group

NO INTERVENTION

Interventions

Aerobic exerciseBEHAVIORAL

Patients with mild cognitive impairment will undergo a one-year aerobic exercise program of 3 units of 45 min / week

Aerobic exercise
Non-aerobic exerciseBEHAVIORAL

Patients with mild cognitive impairment will undergo a one-year stretching and toning (non-aerobic) exercise program of 3 units of 45 min / week

Stretching and Toning

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

German Sport University

Cologne, Germany

Location

Trinity College Dublin

Dublin, Ireland

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 33519425DERIVED

  • 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.

    PMID: 28330458DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

September 23, 2016

Study Start

June 1, 2015

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

November 14, 2019

Record last verified: 2019-11

Locations

DE(1)IE(1)NL(1)