Back to resultsPhysical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial (SMART)
Primary Purpose
Dementia, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Individualised aerobic exercise training
Waiting Control
Sponsored by
About this trial
This is an interventional prevention trial for Dementia focused on measuring Aerobic Exercise Training, prevention, magnetic resonance spectroscopic imaging, psychometric tests, cognition, dementia, cognitive impairment
Eligibility Criteria
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
Sites / Locations
- Department of Sports Medicine, Institute of Sports Sciences, Goethe University
- Institute of General Practice, Goethe University,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Waiting Control
Arm Description
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).
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET)
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]
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]
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]
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)
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)
speed of cognitive processing is assessed by means of the Trail-Making-Test Part A
Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)
depressive disorders: Geriatric Depression Scale
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]
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]
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
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)
Pain Assessment (German Pain Questionnaire)
German Pain Questionnaire
History of diet (Food frequency questionnaire DEGS1)
Food frequency questionnaire DEGS1
History and fear of falling (German version of the Falls-Efficacy-Scale International Version)
German version of the Falls-Efficacy-Scale International Version
Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry)
International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry
Full Information
NCT ID
NCT02343029
First Posted
January 12, 2015
Last Updated
August 31, 2015
Sponsor
Professor Johannes Pantel
1. Study Identification
Unique Protocol Identification Number
NCT02343029
Brief Title
Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
Acronym
SMART
Official Title
Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Johannes Pantel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognitive Impairment
Keywords
Aerobic Exercise Training, prevention, magnetic resonance spectroscopic imaging, psychometric tests, cognition, dementia, cognitive impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Waiting Control
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Individualised aerobic exercise training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting Control
Intervention Description
After waiting for 12 weeks with normal daily activity, patients are allocated to a individualised aerobic exercise training, too.
Primary Outcome Measure Information:
Title
Change in cerebral metabolism (assessed by MRSI)
Description
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
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET)
Description
Aerobic exercise capacity is determined by a physician-supervised CPET
Time Frame
0, 3 and 6 month
Title
Psychometric testing 1 (verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test]
Description
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
Title
Psychometric testing 2 (frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B]
Description
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
Title
Psychometric testing 3 (working memory [Digit Span Test forward and backward]
Description
working memory [Digit Span Test forward and backward]
Time Frame
0, 3 and 6 month
Title
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)
Description
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
Time Frame
0, 3 and 6 month
Title
Psychometric testing 5 (speed of cognitive processing is assessed by means of the Trail-Making-Test Part A)
Description
speed of cognitive processing is assessed by means of the Trail-Making-Test Part A
Time Frame
0, 3 and 6 month
Title
Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)
Description
depressive disorders: Geriatric Depression Scale
Time Frame
0, 3 and 6 month
Title
Psychometric testing 7 (Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q]
Description
Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q]
Time Frame
0, 3 and 6 month
Title
Psychometric testing 8 (cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B]
Description
cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B]
Time Frame
0, 3 and 6 month
Title
Psychometric testing 9 (dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire)
Description
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
Title
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)
Description
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
Title
Pain Assessment (German Pain Questionnaire)
Description
German Pain Questionnaire
Time Frame
0, 3 and 6 month
Title
History of diet (Food frequency questionnaire DEGS1)
Description
Food frequency questionnaire DEGS1
Time Frame
0, 3 and 6 month
Title
History and fear of falling (German version of the Falls-Efficacy-Scale International Version)
Description
German version of the Falls-Efficacy-Scale International Version
Time Frame
0, 3 and 6 month
Title
Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry)
Description
International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry
Time Frame
0, 3 and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Pantel, Prof.
Organizational Affiliation
Institute of General Practice, Goethe University, Frankfurt/Main, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Winfried E Banzer, Prof.
Organizational Affiliation
Department of Sports Medicine, Institute of Sports Sciences, Goethe University, Frankfurt/Main, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Sports Medicine, Institute of Sports Sciences, Goethe University
City
Frankfurt am Main
ZIP/Postal Code
60487
Country
Germany
Facility Name
Institute of General Practice, Goethe University,
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25872789
Citation
Fleckenstein J, Matura S, Engeroff T, Fuzeki 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.
Results Reference
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Learn more about this trial
Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
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