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

Not Applicable

Completed

• Conditions: Dementia; Cognitive Impairment
• Interventions: Other: Individualised aerobic exercise training; Other: Waiting Control

• Registration Number: NCT02343029
• Lead Sponsor: Professor Johannes Pantel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-21
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Individualised aerobic exercise training	Participants in the Intervention group exercise three times a week for 30 minutes on a bicycle ergometer (optibike med, ergoline GmbH, Bitz, Germany) in the integrated gym hall of one of the participating residencies. Training is individualised as respective performance is adapted to the power at the first ventilator threshold (assessed during cardiopulmonary exercise test).
Waiting Control	Waiting Control	Participants of Waiting Control continue their regular physical activity behaviour for 12 weeks. They will start the same exercise intervention after a reassessment at week 12 for the next upcoming 12 weeks. (13-24)
Waiting Control	Individualised aerobic exercise training	Participants of Waiting Control continue their regular physical activity behaviour for 12 weeks. They will start the same exercise intervention after a reassessment at week 12 for the next upcoming 12 weeks. (13-24)

Primary Outcome Measures

Name	Time	Method
Change in cerebral metabolism (assessed by MRSI)	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 Outcome Measures

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

Trial Locations

Locations (2)

Department of Sports Medicine, Institute of Sports Sciences, Goethe University; 🇩🇪 Frankfurt am Main, Germany

Institute of General Practice, Goethe University,; 🇩🇪 Frankfurt am Main, Germany