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CompletedNCT03272061Updated Jan 16, 2019

Exercise and Brain Vascular Function

An interventional study of Aerobic-based exercise program in Physical Exercise, Cerebrovascular Function and Cerebral Blood Flow, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
60 Years to 70 Years
Sex
Male
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Study 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.

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Conditions studied

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

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In context

Motor Activity

2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.

This study's enrollment of 19 is below the median of 60 across 2,309 interventional studies indexed under Motor Activity.

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Lead sponsor

Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Aerobic-based exercise program

    Other: Aerobic-based exercise program

  • No intervention
    Control program

    Maintenance of habitual physical activity levels

Interventions

  • OtherAerobic-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.

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What researchers measure

Primary outcomes

  1. Brain vascular function

    Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

Secondary outcomes

  1. Glucose metabolism

    Oral Glucose Tolerance Test (OGTT)

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  2. Cognitive performance

    Cambridge Neuropsychological Test Automated Battery (CANTAB)

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

Other outcomes

  1. Other physiological parameters: Peripheral vascular function

    Flow-mediated vasodilation (FMD), carotid artery reactivity, pulse wave analysis (PWA) and velocity (PWV), and retinal images

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  2. Other physiological parameters: Blood pressure

    Office and 24-hour ambulatory blood pressure

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  3. Other physiological parameters: Continuous blood glucose

    36-hour glycaemic response

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  4. Other physiological parameters: Advanced glycation endproducts

    Serum protein-bound advanced glycation endproducts (AGEs)

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  5. Other physiological parameters: Conventional metabolic risk markers

    Lipids and lipoproteins, glucose and insulin, and markers for low-grade systemic inflammation and microvascular function

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  6. Other perceivable benefits: Quality of Life

    The Quality of life (QoL) will be assessed using a 32-item questionnaire

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  7. Other perceivable benefits: Sleep characteristics

    Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  8. Other perceivable benefits: Mood

    Mood will be tested using the Affect Grid

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  9. Other perceivable benefits: Physical fitness (1)

    Incremental exhaustive exercise test (VO2 max)

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  10. Other perceivable benefits: Physical fitness (2)

    Timed up-and-go test (TUGT)

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  11. Other perceivable benefits: Physical fitness (3)

    The 6-minute walk test (6 MWT)

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

  12. Other perceivable benefits: Physical fitness (4)

    Handgrip and muscle strength tests

    Time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program

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Study locations

1 site
  • Maastricht University Medical Center
    Maastricht, Netherlands
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References and documents

Publications

  • 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. PubMed 34548089 ↗
  • 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. PubMed 31866855 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03272061
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Dec 1, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Jan 16, 2019

Study contacts

Peter J Joris, PhD
principal investigator · Maastricht University Medical Center
Ronald P Mensink, PhD
principal investigator · Maastricht University Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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