Trial Outcomes & Findings for Sex Differences in Vascular Responses to Exercise (NCT NCT04128215)

Last Updated: 2024-11-14

Results Overview

Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)\*100. The change in FMD for the control period was calculated as the difference in FMD from baseline to the end of the 8-week control period. The change in FMD for the exercise intervention period was calculated as the difference in FMD from the end of the 8-week control period to the end of the 8-week intervention period.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention

Results posted on

2024-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Older Men Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Older Postmenopausal Women Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.
Overall Study STARTED	9	11
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex Differences in Vascular Responses to Exercise

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention

Outcome measures

Outcome measures
Measure	Older Postmenopausal Women n=11 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Older Men n=9 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.
Change in FMD in Response to Chronic HIIT Control period	0.11 % flow mediated dilation Standard Deviation 1.27	0.57 % flow mediated dilation Standard Deviation 2.07
Change in FMD in Response to Chronic HIIT Exercise intervention	0.81 % flow mediated dilation Standard Deviation 1.78	0.10 % flow mediated dilation Standard Deviation 2.36

PRIMARY outcome

Timeframe: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise

Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)\*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the untrained state (before beginning the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).

Outcome measures

Outcome measures
Measure	Older Postmenopausal Women n=9 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Older Men n=11 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.
Change in FMD in Response to Acute HIIT in the Untrained State End of exercise	-0.46 % flow mediated dilation Standard Deviation 2.04	0.19 % flow mediated dilation Standard Deviation 1.85
Change in FMD in Response to Acute HIIT in the Untrained State 1-hour post-exercise	-0.64 % flow mediated dilation Standard Deviation 1.97	-1.28 % flow mediated dilation Standard Deviation 1.69
Change in FMD in Response to Acute HIIT in the Untrained State 24-hours post-exercise	-0.53 % flow mediated dilation Standard Deviation 1.18	0.12 % flow mediated dilation Standard Deviation 1.93

PRIMARY outcome

Timeframe: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise

Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)\*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the trained state (at the end of the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).

Outcome measures

Outcome measures
Measure	Older Postmenopausal Women n=9 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Older Men n=11 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.
Change in FMD in Response to Acute HIIT in the Trained State 1-hour post-exercise	-0.66 % flow mediated dilation Standard Deviation 2.59	-0.63 % flow mediated dilation Standard Deviation 2.15
Change in FMD in Response to Acute HIIT in the Trained State 24-hours post-exercise	-0.45 % flow mediated dilation Standard Deviation 1.71	1.35 % flow mediated dilation Standard Deviation 1.79
Change in FMD in Response to Acute HIIT in the Trained State End of exercise	0.77 % flow mediated dilation Standard Deviation 2.24	-0.07 % flow mediated dilation Standard Deviation 2.32

PRIMARY outcome

Timeframe: Acute FMD response at 1) pre-exercise vs. end of exercise; 2) pre-exercise vs. 1-hour post-exercise; and 3) pre-exercise vs. 24-hours post-exercise. Chronic FMD response at baseline vs. end of 8-week. exercise intervention

Outcome measures

Outcome measures
Measure	Older Postmenopausal Women n=9 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Older Men n=11 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.
Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT End of exercise	-0.32 Correlation coefficient	-0.26 Correlation coefficient
Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT 1-hour post-exercise	0 Correlation coefficient	-0.20 Correlation coefficient
Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT 24-hour post-exercise	-0.17 Correlation coefficient	0.07 Correlation coefficient

Adverse Events

Older Men

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Older Postmenopausal Women

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Older Men n=9 participants at risk Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Older Postmenopausal Women n=11 participants at risk Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.
General disorders Vomiting, dizziness	0.00% 0/9 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	9.1% 1/11 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Immune system disorders Skin allergic reaction	11.1% 1/9 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	0.00% 0/11 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	0.00% 0/11 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Musculoskeletal and connective tissue disorders Knee pain	0.00% 0/9 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	9.1% 1/11 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Musculoskeletal and connective tissue disorders Soft tissue pain	0.00% 0/9 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	9.1% 1/11 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Nervous system disorders Dizziness	0.00% 0/9 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	18.2% 2/11 • Number of events 2 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Nervous system disorders Presyncope	11.1% 1/9 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	0.00% 0/11 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Nervous system disorders Headache	0.00% 0/9 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	9.1% 1/11 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Injury, poisoning and procedural complications Ecchymosis	0.00% 0/9 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	36.4% 4/11 • Number of events 4 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
Injury, poisoning and procedural complications Arterial spasm	11.1% 1/9 • Number of events 1 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.	54.5% 6/11 • Number of events 6 • Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.

Additional Information

Dr. Demetra Christou

University of Florida

Phone: 3522941715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Older Men n=9 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Older Postmenopausal Women n=11 Participants Control Period: Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period. Exercise Period: Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 6 • n=5 Participants	68 years STANDARD_DEVIATION 5 • n=7 Participants	68 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Flow Mediated Dilation	3.41 % of flow mediated dilation STANDARD_DEVIATION 0.89 • n=5 Participants	3.38 % of flow mediated dilation STANDARD_DEVIATION 1.73 • n=7 Participants	3.39 % of flow mediated dilation STANDARD_DEVIATION 1.38 • n=5 Participants