Trial Outcomes & Findings for Cerebrovascular Dysregulation in Chronic Kidney Disease (NCT NCT05571605)
NCT ID: NCT05571605
Last Updated: 2025-07-20
Results Overview
Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity very low frequency phase (radians)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).
Results posted on
2025-07-20
Participant Flow
Participant milestones
| Measure |
Exercise Training
Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session.
Exercise: Participants randomized to this arm will exercise on a stationary bicycle.
|
Stretching
Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes.
Stretching: Participants randomized to this arm will perform stretching and balance exercise.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cerebrovascular Dysregulation in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Exercise Training
n=5 Participants
Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session.
Exercise: Participants randomized to this arm will exercise on a stationary bicycle.
|
Stretching
n=6 Participants
Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes.
Stretching: Participants randomized to this arm will perform stretching and balance exercise.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 7 • n=99 Participants
|
68 years
STANDARD_DEVIATION 6 • n=107 Participants
|
66 years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity very low frequency phase (radians)
Outcome measures
| Measure |
Exercise Training
n=5 Participants
Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session.
|
Stretching
n=6 Participants
Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes.
|
|---|---|---|
|
Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Phase (Radians)
Baseline
|
1.38 Radians
Standard Deviation 0.45
|
1.12 Radians
Standard Deviation 0.64
|
|
Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Phase (Radians)
Post-Training
|
1.40 Radians
Standard Deviation 0.55
|
1.60 Radians
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: Mean arterial pressure-middle cerebral artery blood velocity transfer function gain (cm/s/mmHg) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity data was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity gain (cm/s/mmHg).
Outcome measures
| Measure |
Exercise Training
n=5 Participants
Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session.
|
Stretching
n=6 Participants
Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes.
|
|---|---|---|
|
Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Gain (cm/s/mmHg)
Baseline
|
0.65 Cm/s/mmHg
Standard Deviation 0.31
|
0.67 Cm/s/mmHg
Standard Deviation 0.19
|
|
Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Gain (cm/s/mmHg)
Post-Training
|
0.77 Cm/s/mmHg
Standard Deviation 0.20
|
0.63 Cm/s/mmHg
Standard Deviation 0.24
|
Adverse Events
Exercise Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stretching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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