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Exercise for Improved Cognition and Cardiometabolic Health
Phase 2 & 3
Recruiting
Led By Steven K Malin, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female >40 and <80 years old
Male or female >40 and <80 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to exercise; about 1 week apart
Awards & highlights
Study Summary
This trial will study the effects of exercise on brain insulin resistance, cognition & cardiometabolic health in middle-aged to older adults to reduce Alzheimer's risk.
Who is the study for?
This trial is for men and women aged 40-80 who are not very active (less than 150 minutes of exercise per week), have a BMI between 25 and 45, but aren't pregnant or nursing. It's not for those with serious health issues, recent smokers, or people on certain medications that affect weight or heart rate.Check my eligibility
What is being tested?
The study investigates how a single session of exercise affects brain insulin sensitivity in middle-aged to older adults. It also looks at the relationship between this sensitivity, cognition, and overall cardiometabolic health.See study design
What are the potential side effects?
Since the intervention involves acute physical exercise, potential side effects may include muscle soreness, fatigue, and risk of injury. However, these are common to any new exercise regimen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 80 years old.
Select...
I am between 40 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to exercise; about 1 week apart
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to exercise; about 1 week apart
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain insulin sensitivity
Secondary outcome measures
Blood Free Fatty Acids
Blood Glucose
Carbohydrate Use
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Individuals will exercise for at medium to hard intensity for 1 hour.
Group II: RestActive Control1 Intervention
Individuals will rest for about 1 hour in the seated position to mimic time exercising.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,192 Total Patients Enrolled
4 Trials studying Obesity
353 Patients Enrolled for Obesity
Steven K Malin, PhDPrincipal InvestigatorRutgers University - New Brunswick
3 Previous Clinical Trials
223 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a significant weight change of more than 2 kilograms in the past 3 months.Your body mass index is between 25 and 45 kg/m2.I am between 40 and 80 years old.You have a history of serious health conditions that could affect the study results or your safety.I am currently on medication that affects my heart rate or rhythm.You have conditions that make it unsafe for you to have an MRI scan.You have abnormal kidney function.You have very high levels of triglycerides (over 400 mg/dl) and cholesterol (over 260 mg/dl).Your blood pressure is higher than 160 over 100.You have reasons that make it unsafe for you to take part in physical activity.I am currently on medication to help with weight loss.You do not engage in at least 150 minutes of moderate to high-intensity exercise per week.Your body mass index is between 25 and 45.I am currently smoking or quit less than a year ago.I am between 40 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Rest
- Group 2: Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age requirement for this medical study limited to those over forty years of age?
"This trial is targeting patients aged 40 to 80, resulting in 238 studies for those younger and 1310 experiments dedicated to the elderly."
Answered by AI
Are there any restrictions as to who can volunteer for this clinical experiment?
"With an objective of enrolling 40 persons, this trial is looking for individuals from the ages of 40 to 80 that have been diagnosed with insulin resistance."
Answered by AI
Does this research endeavor currently have space for participants?
"The data on clinicaltrials.gov indicates that this trial, which was first posted in May of 2023 and updated shortly after, is no longer actively recruiting patients. Fortunately, 1787 other trials are presently open for enrollment."
Answered by AI
Who else is applying?
What site did they apply to?
Robert Wood Johnson University Hospital Clinical Research Center
Center for Advanced Human Brain Imaging Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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