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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 September 2015
• Main ID: NCT02343029
• Date of registration: 12/01/2015
• Prospective Registration: No
• Primary sponsor: Professor Johannes Pantel
• Public title: Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial SMART
• Scientific title: Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial
• Date of first enrolment: June 2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02343029
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Winfried E Banzer, Prof.
• Affiliation: Department of Sports Medicine, Institute of Sports Sciences, Goethe University, Frankfurt/Main, Germany

• Name: Johannes Pantel, Prof.
• Affiliation: Institute of General Practice, Goethe University, Frankfurt/Main, Germany

Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia

Cognitive Impairment

Intervention(s)

Other: Individualised aerobic exercise training

Other: Waiting Control

Primary Outcome(s)

Change in cerebral metabolism (assessed by MRSI) [Time Frame: 6 month]

Secondary Outcome(s)

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]

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

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

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]

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

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]

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

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

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]

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

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]

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

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]

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

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]

Secondary ID(s)

SMART

Source(s) of Monetary Support

Please refer to primary and secondary sponsors