Exercise and Brain Vascular Function

Cognitive Performance Clinical Trial

Official title:

The Effects of Aerobic-based Exercise on Brain Vascular Function in Elderly Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272061
• Other study ID #: METC173025
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Blood Flow
• Cerebrovascular Function
• Cognitive Performance
• Glucose Metabolism
• Physical Exercise

Intervention

Other:
• Aerobic-based exercise program
Aerobic-based exercise will be carried out on a cycling ergometer three times a week for 30 minutes at 70% of the maximal workload. Every two weeks, the maximal workload will be reassessed, and training loads will be readjusted accordingly. Fully supervised training sessions will be performed with three-to-four study participants at a time. Subjects should maintain their body weight during the intervention period.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other physiological parameters: Peripheral vascular function	Flow-mediated vasodilation (FMD), carotid artery reactivity, pulse wave analysis (PWA) and velocity (PWV), and retinal images	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other physiological parameters: Blood pressure	Office and 24-hour ambulatory blood pressure	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other physiological parameters: Continuous blood glucose	36-hour glycaemic response	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other physiological parameters: Advanced glycation endproducts	Serum protein-bound advanced glycation endproducts (AGEs)	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other physiological parameters: Conventional metabolic risk markers	Lipids and lipoproteins, glucose and insulin, and markers for low-grade systemic inflammation and microvascular function	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other perceivable benefits: Quality of Life	The Quality of life (QoL) will be assessed using a 32-item questionnaire	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other perceivable benefits: Sleep characteristics	Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other perceivable benefits: Mood	Mood will be tested using the Affect Grid	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other perceivable benefits: Physical fitness (1)	Incremental exhaustive exercise test (VO2 max)	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other perceivable benefits: Physical fitness (2)	Timed up-and-go test (TUGT)	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other perceivable benefits: Physical fitness (3)	The 6-minute walk test (6 MWT)	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Other	Other perceivable benefits: Physical fitness (4)	Handgrip and muscle strength tests	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Primary	Brain vascular function	Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Secondary	Glucose metabolism	Oral Glucose Tolerance Test (OGTT)	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
Secondary	Cognitive performance	Cambridge Neuropsychological Test Automated Battery (CANTAB)	Difference between outcomes at the end of an 8-week aerobic-based exercise and control program