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

Dementia Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343029
• Other study ID #: SMART
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: August 31, 2015
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Dementia

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Sports Medicine, Institute of Sports Sciences, Goethe University	Frankfurt am Main
Germany	Institute of General Practice, Goethe University,	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Professor Johannes Pantel

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Psychometric testing 3 (working memory [Digit Span Test forward and backward]	working memory [Digit Span Test forward and backward]	0, 3 and 6 month	No
Secondary	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	No
Secondary	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	No
Secondary	Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)	depressive disorders: Geriatric Depression Scale	0, 3 and 6 month	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Pain Assessment (German Pain Questionnaire)	German Pain Questionnaire	0, 3 and 6 month	No
Secondary	History of diet (Food frequency questionnaire DEGS1)	Food frequency questionnaire DEGS1	0, 3 and 6 month	No
Secondary	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	No
Secondary	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	No

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