Clinical trial NCT02343029: Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
Official title: Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Cognitive Impairment
Keywords: Aerobic Exercise Training
prevention
magnetic resonance spectroscopic imaging
psychometric tests
cognition
dementia
cognitive impairment
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. be above 65 years of age,
2. voluntariness
3. capacity to consent,
4. having passed medical entry exam by the Department of Sports Medicine,

4) regular mental capacity, 5) written informed consent

Exclusion Criteria:

1. untreated clotting disorders,
2. musculoskeletal diseases significantly reducing mobility,
3. severe bacterial or viral infections,
4. severe respiratory diseases (Gold IV),
5. acute pulmonary embolism,
6. instable angina pectoris or severe heart failure (NYHA III or IV),
7. severe vascular disease of the extremities or the brain,
8. severe pulmonary-cardiac dysfunction,
9. acute myocardial infarction or early phase of rehabilitation,
10. critical aortal stenosis,
11. severe hypertrophic and obstructive cardiomyopathy,
12. untreated malignant arrhythmias,
13. untreated severe hypertonia,
14. severe pulmonary hypertonia,
15. symptomatic cardiac malformations,
16. cardiac-block grade II or III,
17. left bundle branch block,
18. complex ventricular arrhythmias,
19. Cognitive impairment

Primary outcomes:
measure: Change in cerebral metabolism (assessed by MRSI)
timeFrame: 6 month
Secondary outcomes:
measure: Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET)
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 1 (verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test]
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 2 (frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B]
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 3 (working memory [Digit Span Test forward and backward]
timeFrame: 0, 3 and 6 month
measure: 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)
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 5 (speed of cognitive processing is assessed by means of the Trail-Making-Test Part A)
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 7 (Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q]
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 8 (cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B]
timeFrame: 0, 3 and 6 month
measure: Psychometric testing 9 (dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire)
timeFrame: 0, 3 and 6 month
measure: 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)
timeFrame: 0, 3 and 6 month
measure: Pain Assessment (German Pain Questionnaire)
timeFrame: 0, 3 and 6 month
measure: History of diet (Food frequency questionnaire DEGS1)
timeFrame: 0, 3 and 6 month
measure: History and fear of falling (German version of the Falls-Efficacy-Scale International Version)
timeFrame: 0, 3 and 6 month
measure: Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry)
timeFrame: 0, 3 and 6 month
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of Sports Medicine, Institute of Sports Sciences, Goethe University
city: Frankfurt am Main
country: Germany
facility: Institute of General Practice, Goethe University,
Study officials:
affiliation: Institute of General Practice, Goethe University, Frankfurt/Main, Germany
name: Johannes Pantel, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Sports Medicine, Institute of Sports Sciences, Goethe University, Frankfurt/Main, Germany
name: Winfried E Banzer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleckenstein J, Matura S, Engeroff T, Fuzeki E, Tesky VA, Pilatus U, Hattingen E, Deichmann R, Vogt L, Banzer W, Pantel J. SMART: physical activity and cerebral metabolism in older people: study protocol for a randomised controlled trial. Trials. 2015 Apr 11;16:155. doi: 10.1186/s13063-015-0662-9.