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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG063143 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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A key early event in cardiovascular disease development is endothelial dysfunction, characterized by impaired flow-mediated dilation. Regular aerobic exercise ameliorates endothelial dysfunction in healthy older men, but the data in healthy postmenopausal women are inconsistent with many studies showing no effect. The primary objective of this study was to examine sex differences in acute and chronic endothelial responses to exercise training in older men vs. older postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older Men | Active Comparator |
| |
| Older Postmenopausal Women | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Period | Behavioral | Participants completed an 8-week control period of normal lifestyle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in FMD in Response to Chronic HIIT | 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. | From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention |
| Change in FMD in Response to Acute HIIT in the Untrained State | 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). | From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise |
| Change in FMD in Response to Acute HIIT in the Trained State | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Demetra Christou, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Cardiovasculal Physiology Laboratory, University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in FMD in Response to Chronic HIIT | 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. | Posted | Mean | Standard Deviation | % flow mediated dilation | From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention |
|
Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting, dizziness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Demetra Christou | University of Florida | 3522941715 | ddchristou@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2022 | Jul 24, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2021 | Jul 24, 2024 | ICF_001.pdf |
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| Exercise Period | Behavioral | Participants completed an 8-week exercise intervention period of remotely supervised home-based non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT consisted 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 were included. |
|
| From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise |
| Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Flow Mediated Dilation | Mean | Standard Deviation | % of flow mediated dilation |
|
| OG001 | 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. |
|
|
| Primary | Change in FMD in Response to Acute HIIT in the Untrained State | 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). | Posted | Mean | Standard Deviation | % flow mediated dilation | From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise |
|
|
|
| Primary | Change in FMD in Response to Acute HIIT in the Trained State | 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). | Posted | Mean | Standard Deviation | % flow mediated dilation | From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise |
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| Primary | Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT | Posted | Number | Correlation coefficient | 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 |
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| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 8 | 11 |
| Skin allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Soft tissue pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Ecchymosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Arterial spasm | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| 24-hours post-exercise |
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| 24-hours post-exercise |
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| 24-hour post-exercise |
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