<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272061</url>
  </required_header>
  <id_info>
    <org_study_id>METC173025</org_study_id>
    <nct_id>NCT03272061</nct_id>
  </id_info>
  <brief_title>Exercise and Brain Vascular Function</brief_title>
  <official_title>The Effects of Aerobic-based Exercise on Brain Vascular Function in Elderly Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive performance is negatively related to an impaired glucose metabolism, possibly due&#xD;
      to impairments in brain vascular function. Supported by the statement from the American Heart&#xD;
      and Stroke Association that physical exercise is one of the most effective strategies to&#xD;
      protect against cognitive decline, we now hypothesize that exercise-induced changes in&#xD;
      glucose metabolism cause beneficial effects on brain vascular function thereby improving&#xD;
      cognitive performance. The primary objective of this intervention study is thus to evaluate&#xD;
      in sedentary elderly men the effect of a 8-week aerobic-based exercise program on cerebral&#xD;
      blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)&#xD;
      perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive&#xD;
      physiological marker of brain vascular function. Secondary objectives are to examine effects&#xD;
      on glucose metabolism using the oral glucose tolerance test and cognitive performance as&#xD;
      assessed with a neurophysiological test battery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain vascular function</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Oral Glucose Tolerance Test (OGTT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Cambridge Neuropsychological Test Automated Battery (CANTAB)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other physiological parameters: Peripheral vascular function</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Flow-mediated vasodilation (FMD), carotid artery reactivity, pulse wave analysis (PWA) and velocity (PWV), and retinal images</description>
  </other_outcome>
  <other_outcome>
    <measure>Other physiological parameters: Blood pressure</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Office and 24-hour ambulatory blood pressure</description>
  </other_outcome>
  <other_outcome>
    <measure>Other physiological parameters: Continuous blood glucose</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>36-hour glycaemic response</description>
  </other_outcome>
  <other_outcome>
    <measure>Other physiological parameters: Advanced glycation endproducts</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Serum protein-bound advanced glycation endproducts (AGEs)</description>
  </other_outcome>
  <other_outcome>
    <measure>Other physiological parameters: Conventional metabolic risk markers</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Lipids and lipoproteins, glucose and insulin, and markers for low-grade systemic inflammation and microvascular function</description>
  </other_outcome>
  <other_outcome>
    <measure>Other perceivable benefits: Quality of Life</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>The Quality of life (QoL) will be assessed using a 32-item questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Other perceivable benefits: Sleep characteristics</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Other perceivable benefits: Mood</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Mood will be tested using the Affect Grid</description>
  </other_outcome>
  <other_outcome>
    <measure>Other perceivable benefits: Physical fitness (1)</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Incremental exhaustive exercise test (VO2 max)</description>
  </other_outcome>
  <other_outcome>
    <measure>Other perceivable benefits: Physical fitness (2)</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Timed up-and-go test (TUGT)</description>
  </other_outcome>
  <other_outcome>
    <measure>Other perceivable benefits: Physical fitness (3)</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>The 6-minute walk test (6 MWT)</description>
  </other_outcome>
  <other_outcome>
    <measure>Other perceivable benefits: Physical fitness (4)</measure>
    <time_frame>Difference between outcomes at the end of an 8-week aerobic-based exercise and control program</time_frame>
    <description>Handgrip and muscle strength tests</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Physical Exercise</condition>
  <condition>Cerebrovascular Function</condition>
  <condition>Cerebral Blood Flow</condition>
  <condition>Glucose Metabolism</condition>
  <condition>Cognitive Performance</condition>
  <arm_group>
    <arm_group_label>Aerobic-based exercise program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Maintenance of habitual physical activity levels</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic-based exercise program</intervention_name>
    <description>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.</description>
    <arm_group_label>Aerobic-based exercise program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 60-70 years&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  BMI between 25-35 kg/m2 (overweight and slightly obese)&#xD;
&#xD;
          -  Sedentary (not moderately active for 3 times or more per week)&#xD;
&#xD;
          -  Fasting plasma glucose &lt; 7.0 mmol/L&#xD;
&#xD;
          -  Fasting serum total cholesterol &lt; 8.0 mmol/L&#xD;
&#xD;
          -  Fasting serum triacylglycerol &lt; 4.5 mmol/L&#xD;
&#xD;
          -  Systolic blood pressure &lt; 160 mmHg and diastolic blood pressure &lt; 100 mmHg&#xD;
&#xD;
          -  Stable body weight (weight gain or loss &lt; 3 kg in the past three months)&#xD;
&#xD;
          -  Willingness to give up being a blood donor from 8 weeks before the start of the study,&#xD;
             during the study and for 4 weeks after completion of the study&#xD;
&#xD;
          -  No difficult venipuncture as evidenced during the screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Current smoker, or smoking cessation &lt; 12 months&#xD;
&#xD;
          -  Diabetic patients&#xD;
&#xD;
          -  Familial hypercholesterolemia&#xD;
&#xD;
          -  Abuse of drugs&#xD;
&#xD;
          -  More than 3 alcoholic consumptions per day&#xD;
&#xD;
          -  Use of dietary supplements known to interfere with the main study outcomes as judged&#xD;
             by the principal investigators&#xD;
&#xD;
          -  Use medication to treat blood pressure, lipid or glucose metabolism&#xD;
&#xD;
          -  Use of an investigational product within another biomedical intervention trial within&#xD;
             the previous 1-month&#xD;
&#xD;
          -  Severe medical conditions that might interfere with the study, such as epilepsy,&#xD;
             asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease,&#xD;
             inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis&#xD;
&#xD;
          -  Active cardiovascular disease like congestive heart failure or cardiovascular event,&#xD;
             such as an acute myocardial infarction or cerebrovascular accident&#xD;
&#xD;
          -  Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body,&#xD;
             metal splinter in eye, claustrophobia)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter J Joris, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald P Mensink, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272061
org study id: METC173025
nct id: NCT03272061
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
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
masking: Single (Outcomes Assessor)
measure: Brain vascular function
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
measure: Glucose metabolism
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Oral Glucose Tolerance Test (OGTT)
measure: Cognitive performance
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Cambridge Neuropsychological Test Automated Battery (CANTAB)
measure: Other physiological parameters: Peripheral vascular function
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Flow-mediated vasodilation (FMD), carotid artery reactivity, pulse wave analysis (PWA) and velocity (PWV), and retinal images
measure: Other physiological parameters: Blood pressure
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Office and 24-hour ambulatory blood pressure
measure: Other physiological parameters: Continuous blood glucose
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: 36-hour glycaemic response
measure: Other physiological parameters: Advanced glycation endproducts
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Serum protein-bound advanced glycation endproducts (AGEs)
measure: 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
description: Lipids and lipoproteins, glucose and insulin, and markers for low-grade systemic inflammation and microvascular function
measure: Other perceivable benefits: Quality of Life
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: The Quality of life (QoL) will be assessed using a 32-item questionnaire
measure: Other perceivable benefits: Sleep characteristics
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index
measure: Other perceivable benefits: Mood
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Mood will be tested using the Affect Grid
measure: Other perceivable benefits: Physical fitness (1)
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Incremental exhaustive exercise test (VO2 max)
measure: Other perceivable benefits: Physical fitness (2)
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Timed up-and-go test (TUGT)
measure: Other perceivable benefits: Physical fitness (3)
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: The 6-minute walk test (6 MWT)
measure: Other perceivable benefits: Physical fitness (4)
time frame: Difference between outcomes at the end of an 8-week aerobic-based exercise and control program
description: Handgrip and muscle strength tests
arm group label: Aerobic-based exercise program
arm group type: Experimental
arm group label: Control program
arm group type: No Intervention
description: Maintenance of habitual physical activity levels
intervention type: Other
intervention name: Aerobic-based exercise program
description: 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.
arm group label: Aerobic-based exercise program
criteria: 
gender: Male
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter J Joris, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
last name: Ronald P Mensink, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor