Trial Outcomes & Findings for Aerobic Exercise and Cerebrovascular Function (NCT NCT03803904)
NCT ID: NCT03803904
Last Updated: 2026-05-07
Results Overview
CVR will be assessed using 5% CO2 challenge while continuously acquiring MR images. This method has been extensively used and is the most suitable vasoactive stimulus. Briefly, the CO2 air (5% CO2, 21% O2 and 74% N2) will be administered via an air bag with a valve to switch between room air and CO2 air in the bag. A mouth piece and a nose clip will be used to achieve mouth-only breathing. A research staff member will be inside the magnet room throughout the experiment to switch the valve and to monitor the subject. Physiologic parameters, including end-tidal (Et) CO2 and breathing rate will be monitored and recorded during the experiments. The percentage of change in Blood-Oxygen-Level-Dependent (BOLD) signal per millimeter of mercury is the metric used to quantify CVR. It measures how much the BOLD signal changes in response to a 1 mmHg change in the end-tidal partial pressure of carbon dioxide.
ACTIVE_NOT_RECRUITING
NA
37 participants
At the Pre-intervention assessment and 12-weeks following at the Post intervention assessment
2026-05-07
Participant Flow
Participant milestones
| Measure |
Spin
The intervention will take place three times a week for 12 weeks and will be led by a qualified instructor (an Exercise Physiologist with five years of experience conducting the intervention). The duration of each session will be increased by 1-2 minutes to a maximum time of 45 minutes per session based on the progression of the participants and the recommendation of the instructor. Because participants are initially sedentary and detrained, exercise intensity will begin at low levels (50% of maximal heart rate reserve, HRR) but will be increased by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.
|
Control
Participants in the control group will be equalized (frequency and duration) to the Spin group for contact and monitoring. As such they will report to the same facility and interact with the same experienced interventionist; however instead of progressive Spin exercise they will participate in sessions focused on balance and stretching. Similar to the aerobic intervention, these exercises will take place in a group setting and heart rate will be consistently monitored during each session to verify heart rate does not reach 50% HRR.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
15
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aerobic Exercise and Cerebrovascular Function
Baseline characteristics by cohort
| Measure |
Spin
n=22 Participants
The intervention will take place three times a week for 12 weeks and will be led by a qualified instructor (an Exercise Physiologist with five years of experience conducting the intervention). The duration of each session will be increased by 1-2 minutes to a maximum time of 45 minutes per session based on the progression of the participants and the recommendation of the instructor. Because participants are initially sedentary and detrained, exercise intensity will begin at low levels (50% of maximal heart rate reserve, HRR) but will be increased by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.
|
Control
n=15 Participants
Participants in the control group will be equalized (frequency and duration) to the Spin group for contact and monitoring. As such they will report to the same facility and interact with the same experienced interventionist; however instead of progressive Spin exercise they will participate in sessions focused on balance and stretching. Similar to the aerobic intervention, these exercises will take place in a group setting and heart rate will be consistently monitored during each session to verify heart rate does not reach 50% HRR.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=54 Participants
|
15 Participants
n=60 Participants
|
35 Participants
n=114 Participants
|
|
Age, Continuous
|
70.18 years
STANDARD_DEVIATION 3.61 • n=54 Participants
|
72.88 years
STANDARD_DEVIATION 4.36 • n=60 Participants
|
71.04 years
STANDARD_DEVIATION 3.98 • n=114 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
23 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=54 Participants
|
12 Participants
n=60 Participants
|
30 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=54 Participants
|
15 Participants
n=60 Participants
|
37 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: At the Pre-intervention assessment and 12-weeks following at the Post intervention assessmentCVR will be assessed using 5% CO2 challenge while continuously acquiring MR images. This method has been extensively used and is the most suitable vasoactive stimulus. Briefly, the CO2 air (5% CO2, 21% O2 and 74% N2) will be administered via an air bag with a valve to switch between room air and CO2 air in the bag. A mouth piece and a nose clip will be used to achieve mouth-only breathing. A research staff member will be inside the magnet room throughout the experiment to switch the valve and to monitor the subject. Physiologic parameters, including end-tidal (Et) CO2 and breathing rate will be monitored and recorded during the experiments. The percentage of change in Blood-Oxygen-Level-Dependent (BOLD) signal per millimeter of mercury is the metric used to quantify CVR. It measures how much the BOLD signal changes in response to a 1 mmHg change in the end-tidal partial pressure of carbon dioxide.
Outcome measures
| Measure |
Spin
n=15 Participants
The intervention will take place three times a week for 12 weeks and will be led by a qualified instructor (an Exercise Physiologist with five years of experience conducting the intervention). The duration of each session will be increased by 1-2 minutes to a maximum time of 45 minutes per session based on the progression of the participants and the recommendation of the instructor. Because participants are initially sedentary and detrained, exercise intensity will begin at low levels (50% of maximal heart rate reserve, HRR) but will be increased by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.
|
Control
n=7 Participants
Active Comparator: Control Participants in the control group will be equalized (frequency and duration) to the Spin group for contact and monitoring. As such they will report to the same facility and interact with the same experienced interventionist; however instead of progressive Spin exercise they will participate in sessions focused on balance and stretching. Similar to the aerobic intervention, these exercises will take place in a group setting and heart rate will be consistently monitored during each session to verify heart rate does not reach 50% HRR.
|
|---|---|---|
|
Cerebrovascular Reactivity (CVR) Using a Hypercapnic CO2 Response Test Change
|
0.120 percentage of change BOLD/mmHg
Standard Deviation 0.057
|
0.133 percentage of change BOLD/mmHg
Standard Deviation 0.036
|
Adverse Events
Spin
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place