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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Dementia
• Intervention / Treatment: Other: Individualised aerobic exercise training; Other: Waiting Control

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60487
    • Department of Sports Medicine, Institute of Sports Sciences, Goethe University
  • Frankfurt am Main, Germany, 60590
    • Institute of General Practice, Goethe University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.
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)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Psychometric testing 3 (working memory [Digit Span Test forward and backward]	working memory [Digit Span Test forward and backward]	0, 3 and 6 month
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
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
Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)	depressive disorders: Geriatric Depression Scale	0, 3 and 6 month
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
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
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
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
Pain Assessment (German Pain Questionnaire)	German Pain Questionnaire	0, 3 and 6 month
History of diet (Food frequency questionnaire DEGS1)	Food frequency questionnaire DEGS1	0, 3 and 6 month
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
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

Collaborators and Investigators

• Sponsor: Professor Johannes Pantel
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 12, 2015
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: dementia; cognition; prevention; cognitive impairment; Aerobic Exercise Training; magnetic resonance spectroscopic imaging; psychometric tests
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: SMART