Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial

Professor Johannes Pantel2 sites in 1 country60 target enrollmentJune 2014

ConditionsDementia Cognitive Impairment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dementia
Sponsor: Professor Johannes Pantel
Enrollment: 60
Locations: 2
Primary Endpoint: Change in cerebral metabolism (assessed by MRSI)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Physical activity exerts a variety of long-term health benefits in older adults.This randomised controlled trial investigates the effect of a 12-week physical exercise program on the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging. Follow-up lasts for 6 months.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

August 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Professor Johannes Pantel

Responsible Party

Sponsor Investigator

Principal Investigator

Professor Johannes Pantel

Head of Department, Institute of General Practice

Goethe University

Eligibility Criteria

Inclusion Criteria

•be above 65 years of age,
•voluntariness
•capacity to consent,
•having passed medical entry exam by the Department of Sports Medicine,
•regular mental capacity, 5) written informed consent

Exclusion Criteria

•untreated clotting disorders,
•musculoskeletal diseases significantly reducing mobility,
•severe bacterial or viral infections,
•severe respiratory diseases (Gold IV),
•acute pulmonary embolism,
•instable angina pectoris or severe heart failure (NYHA III or IV),
•severe vascular disease of the extremities or the brain,
•severe pulmonary-cardiac dysfunction,
•acute myocardial infarction or early phase of rehabilitation,
•critical aortal stenosis,

Outcomes

Primary Outcomes

Change in cerebral metabolism (assessed by MRSI)

Time Frame: 6 month

assessed by MRSI, Primary hypothesis is that aerobic exercise leads to an increase of cerebral N-acetyl-aspartate (NAA; mediated by plasma neurotrophins). Secondary hypothesis stipulates an increase of markers of neuronal energy reserve: i.e. the ratio of phosphocreatinin to creatinine and of adenosine-tri-phosphate (ATP) to \~di-phosphate (ADP). Third hypothesis is an increase in the volume of cortical grey matter

Secondary Outcomes

Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET)(0, 3 and 6 month)
Psychometric testing 5 (speed of cognitive processing is assessed by means of the Trail-Making-Test Part A)(0, 3 and 6 month)
Psychometric testing 1 (verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test](0, 3 and 6 month)
Psychometric testing 2 (frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B](0, 3 and 6 month)
Psychometric testing 8 (cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B](0, 3 and 6 month)
Psychometric testing 3 (working memory [Digit Span Test forward and backward](0, 3 and 6 month)
Balance and strength (postural sway (balance) and gait data acquisition via the capacitive force-measuring platform (30 Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)(0, 3 and 6 month)
Pain Assessment (German Pain Questionnaire)(0, 3 and 6 month)
History of diet (Food frequency questionnaire DEGS1)(0, 3 and 6 month)
History and fear of falling (German version of the Falls-Efficacy-Scale International Version)(0, 3 and 6 month)
Psychometric testing 4 9semantic and phonematic fluency, nonverbal declarative memory and visual-constructive abilities by means of the CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease) Neuropsychological Battery)(0, 3 and 6 month)
Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)(0, 3 and 6 month)
Psychometric testing 7 (Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q](0, 3 and 6 month)
Psychometric testing 9 (dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire)(0, 3 and 6 month)
Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry)(0, 3 and 6 month)