Clinical trial NCT03272061: Exercise and Brain Vascular Function
Official title: The Effects of Aerobic-based Exercise on Brain Vascular Function in Elderly Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Exercise
Cerebrovascular Function
Cerebral Blood Flow
Glucose Metabolism
Cognitive Performance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 19
Sex: MALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will follow in randomized order a tightly controlled, progressive, aerobic-based exercise program or control program for eight weeks, separated by a washout period of twelve weeks.
Primary purpose: PREVENTION

Brief summary: Cognitive performance is negatively related to an impaired glucose metabolism, possibly due to impairments in brain vascular function. Supported by the statement from the American Heart and Stroke Association that physical exercise is one of the most effective strategies to protect against cognitive decline, we now hypothesize that exercise-induced changes in glucose metabolism cause beneficial effects on brain vascular function thereby improving cognitive performance. The primary objective of this intervention study is thus to evaluate in sedentary elderly men the effect of a 8-week aerobic-based exercise program on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to examine effects on glucose metabolism using the oral glucose tolerance test and cognitive performance as assessed with a neurophysiological test battery.


Eligibility criteria: Inclusion Criteria:

* Aged between 60-70 years
* Men
* BMI between 25-35 kg/m2 (overweight and slightly obese)
* Sedentary (not moderately active for 3 times or more per week)
* Fasting plasma glucose \< 7.0 mmol/L
* Fasting serum total cholesterol \< 8.0 mmol/L
* Fasting serum triacylglycerol \< 4.5 mmol/L
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
* No difficult venipuncture as evidenced during the screening visit

Exclusion Criteria:

* Women
* Current smoker, or smoking cessation \< 12 months
* Diabetic patients
* Familial hypercholesterolemia
* Abuse of drugs
* More than 3 alcoholic consumptions per day
* Use of dietary supplements known to interfere with the main study outcomes as judged by the principal investigators
* Use medication to treat blood pressure, lipid or glucose metabolism
* Use of an investigational product within another biomedical intervention trial within the previous 1-month
* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
* Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)

Primary outcomes:
measure: Brain vascular function
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Secondary outcomes:
measure: Glucose metabolism
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Cognitive performance
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other outcomes:
measure: Other physiological parameters: Peripheral vascular function
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other physiological parameters: Blood pressure
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other physiological parameters: Continuous blood glucose
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other physiological parameters: Advanced glycation endproducts
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other physiological parameters: Conventional metabolic risk markers
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other perceivable benefits: Quality of Life
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other perceivable benefits: Sleep characteristics
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other perceivable benefits: Mood
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other perceivable benefits: Physical fitness (1)
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other perceivable benefits: Physical fitness (2)
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other perceivable benefits: Physical fitness (3)
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
measure: Other perceivable benefits: Physical fitness (4)
timeFrame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Peter J Joris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Ronald P Mensink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mashnafi S, Plat J, Mensink RP, Joris PJ, Kleinloog JPD, Baumgartner S. Effects of an 8-week aerobic exercise program on plasma markers for cholesterol absorption and synthesis in older overweight and obese men. Lipids Health Dis. 2021 Sep 21;20(1):112. doi: 10.1186/s12944-021-01537-2.
citation: Kleinloog JPD, Mensink RP, Ivanov D, Adam JJ, Uludag K, Joris PJ. Aerobic Exercise Training Improves Cerebral Blood Flow and Executive Function: A Randomized, Controlled Cross-Over Trial in Sedentary Older Men. Front Aging Neurosci. 2019 Dec 4;11:333. doi: 10.3389/fnagi.2019.00333. eCollection 2019.