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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 12, 2015
First Posted Date  ICMJE January 21, 2015
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • 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
  • 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]
  • 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]
  • 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]
  • 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
  • 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
  • Psychometric testing 6 (depressive disorders: Geriatric Depression Scale) [ Time Frame: 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] [ Time Frame: 0, 3 and 6 month ]
    Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q]
  • 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]
  • 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
  • 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)
  • Pain Assessment (German Pain Questionnaire) [ Time Frame: 0, 3 and 6 month ]
    German Pain Questionnaire
  • History of diet (Food frequency questionnaire DEGS1) [ Time Frame: 0, 3 and 6 month ]
    Food frequency questionnaire DEGS1
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
Official Title  ICMJE Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Dementia
  • Cognitive Impairment
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Other: Individualised aerobic exercise training
  • 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)
    Interventions:
    • Other: Individualised aerobic exercise training
    • Other: Waiting Control
Publications * Fleckenstein J, Matura S, Engeroff T, Füzéki 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02343029
Other Study ID Numbers  ICMJE SMART
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Professor Johannes Pantel, Goethe University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Professor Johannes Pantel
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Goethe University
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP