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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dementia, Cognitive Impairment

Intervention / Treatment
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* Other: Individualised aerobic exercise training
* Other: Waiting Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be above 65 years of age, voluntariness capacity to consent, having passed medical entry exam by the Department of Sports Medicine, 4) 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, severe hypertrophic and obstructive cardiomyopathy, untreated malignant arrhythmias, untreated severe hypertonia, severe pulmonary hypertonia, symptomatic cardiac malformations, cardiac-block grade II or III, left bundle branch block, complex ventricular arrhythmias, Cognitive impairment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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). | Other: Individualised aerobic exercise training<br>* During the first 4 weeks of intervention two of the three weekly training sessions are offered as group training supervised by the respective qualified exercise physiologist of the Department of Sports Medicine. After 4 weeks, participants' physical performance is reassessed at the Department of Sports Medicine. If necessary, workload is readjusted to achieve the initially defined exercise intensity.<br>|
| Active Comparator: Waiting Control<br>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) | Other: Individualised aerobic exercise training<br>* During the first 4 weeks of intervention two of the three weekly training sessions are offered as group training supervised by the respective qualified exercise physiologist of the Department of Sports Medicine. After 4 weeks, participants' physical performance is reassessed at the Department of Sports Medicine. If necessary, workload is readjusted to achieve the initially defined exercise intensity.<br>Other: Waiting Control<br>* After waiting for 12 weeks with normal daily activity, patients are allocated to a individualised aerobic exercise training, too.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral metabolism (assessed by MRSI) | 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 | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET) | Aerobic exercise capacity is determined by a physician-supervised CPET | 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] | 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] | 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 3 (working memory [Digit Span Test forward and backward] | working memory [Digit Span Test forward and backward] | 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) | 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 | 0, 3 and 6 month | 
| Psychometric testing 5 (speed of cognitive processing is assessed by means of the Trail-Making-Test Part A) | speed of cognitive processing is assessed by means of the Trail-Making-Test Part A | 0, 3 and 6 month | 
| Psychometric testing 6 (depressive disorders: Geriatric Depression Scale) | 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] | Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q] | 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] | cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B] | 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) | dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire | 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) | 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) | German Pain Questionnaire | 0, 3 and 6 month | 
| History of diet (Food frequency questionnaire DEGS1) | Food frequency questionnaire DEGS1 | 0, 3 and 6 month | 
| History and fear of falling (German version of the Falls-Efficacy-Scale International Version) | German version of the Falls-Efficacy-Scale International Version | 0, 3 and 6 month | 
| Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry) | International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry | 0, 3 and 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic Exercise Training, prevention, magnetic resonance spectroscopic imaging, psychometric tests, cognition, dementia, cognitive impairment