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Completed

NCT Number: NCT03272061

Exercise and Brain Vascular Function

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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Key information

Conditions

Physical Exercise Behavior Cerebral Blood Flow Cerebrovascular Function Cognitive Performance Glucose Metabolism Motor Activity

Age range

60 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aerobic-based exercise program

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.

Primary outcomes

  1. Brain vascular function

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

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

Secondary outcomes

  1. Glucose metabolism

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

    Oral Glucose Tolerance Test (OGTT)

  2. Cognitive performance

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

    Cambridge Neuropsychological Test Automated Battery (CANTAB)

Other outcomes

  1. Other physiological parameters: Peripheral vascular function

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

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

  2. Other physiological parameters: Blood pressure

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

    Office and 24-hour ambulatory blood pressure

  3. Other physiological parameters: Continuous blood glucose

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

    36-hour glycaemic response

  4. Other physiological parameters: Advanced glycation endproducts

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

    Serum protein-bound advanced glycation endproducts (AGEs)

  5. Other physiological parameters: Conventional metabolic risk markers

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

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

  6. Other perceivable benefits: Quality of Life

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

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

  7. Other perceivable benefits: Sleep characteristics

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

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

  8. Other perceivable benefits: Mood

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

    Mood will be tested using the Affect Grid

  9. Other perceivable benefits: Physical fitness (1)

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

    Incremental exhaustive exercise test (VO2 max)

  10. Other perceivable benefits: Physical fitness (2)

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

    Timed up-and-go test (TUGT)

  11. Other perceivable benefits: Physical fitness (3)

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

    The 6-minute walk test (6 MWT)

  12. Other perceivable benefits: Physical fitness (4)

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

    Handgrip and muscle strength tests

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2017
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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