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Completed

NCT Number: NCT02343029

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be above 65 years of age,
  • voluntariness
  • capacity to consent,
  • having passed medical entry exam by the Department of Sports Medicine,
  • 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

Treatment and study plan

Individualised aerobic exercise training

Other

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.

Waiting Control

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Professor Johannes Pantel

Other

Registry information

Acronym: SMART

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2015
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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