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

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ClinicalTrials.gov Identifier: NCT02343029
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Professor Johannes Pantel, Goethe University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Cognitive Impairment Other: Individualised aerobic exercise training Other: Waiting Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
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
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.
Active Comparator: 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)
 Other: Individualised aerobic exercise training
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.

Other: Waiting Control
After waiting for 12 weeks with normal daily activity, patients are allocated to a individualised aerobic exercise training, too.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET) [ Time Frame: 0, 3 and 6 month ]
    Aerobic exercise capacity is determined by a physician-supervised CPET

  2. Psychometric testing 1 (verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test] [ Time Frame: 0, 3 and 6 month ]
    verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test]

  3. Psychometric testing 2 (frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B] [ Time Frame: 0, 3 and 6 month ]
    frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B]

  4. Psychometric testing 3 (working memory [Digit Span Test forward and backward] [ Time Frame: 0, 3 and 6 month ]
    working memory [Digit Span Test forward and backward]

  5. 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) [ Time Frame: 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

  6. Psychometric testing 5 (speed of cognitive processing is assessed by means of the Trail-Making-Test Part A) [ Time Frame: 0, 3 and 6 month ]
    speed of cognitive processing is assessed by means of the Trail-Making-Test Part A

  7. Psychometric testing 6 (depressive disorders: Geriatric Depression Scale) [ Time Frame: 0, 3 and 6 month ]
    depressive disorders: Geriatric Depression Scale

  8. Psychometric testing 7 (Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q] [ Time Frame: 0, 3 and 6 month ]
    Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q]

  9. Psychometric testing 8 (cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B] [ Time Frame: 0, 3 and 6 month ]
    cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B]

  10. Psychometric testing 9 (dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire) [ Time Frame: 0, 3 and 6 month ]
    dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire

  11. 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) [ Time Frame: 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)

  12. Pain Assessment (German Pain Questionnaire) [ Time Frame: 0, 3 and 6 month ]
    German Pain Questionnaire

  13. History of diet (Food frequency questionnaire DEGS1) [ Time Frame: 0, 3 and 6 month ]
    Food frequency questionnaire DEGS1

  14. History and fear of falling (German version of the Falls-Efficacy-Scale International Version) [ Time Frame: 0, 3 and 6 month ]
    German version of the Falls-Efficacy-Scale International Version

  15. Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry) [ Time Frame: 0, 3 and 6 month ]
    International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343029


Locations
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Germany
Department of Sports Medicine, Institute of Sports Sciences, Goethe University
Frankfurt am Main, Germany, 60487
Institute of General Practice, Goethe University,
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Professor Johannes Pantel
Investigators
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Principal Investigator: Johannes Pantel, Prof. Institute of General Practice, Goethe University, Frankfurt/Main, Germany
Principal Investigator: Winfried E Banzer, Prof. Department of Sports Medicine, Institute of Sports Sciences, Goethe University, Frankfurt/Main, Germany
More Information
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Publications:

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Responsible Party: Professor Johannes Pantel, Head of Department, Institute of General Practice, Goethe University
ClinicalTrials.gov Identifier: NCT02343029    
Other Study ID Numbers: SMART
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by Professor Johannes Pantel, Goethe University:
Aerobic Exercise Training
prevention
magnetic resonance spectroscopic imaging
psychometric tests
 cognition
dementia
cognitive impairment
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders