Exercise and Brain Vascular Function

NCT ID: NCT03272061

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Aerobic-based exercise program

Group Type: EXPERIMENTAL

Aerobic-based exercise program

Intervention Type: OTHER

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.

Control program

Maintenance of habitual physical activity levels

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter J Joris, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Ronald P Mensink, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 34548089 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31866855 (View on PubMed)

Other Identifiers

METC173025

Identifier Type: -

Identifier Source: org_study_id