Trial · NCT04181606
Age Comparisons of Exercising Muscle O2 Supply in Healthy Adults: Effects of Esmolol Infusion
NCT04181606, Early phase 1, Completed, David N. Proctor, PhD; results first posted 2025-05-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Age Comparisons of Exercising Muscle O2 Supply in Healthy Adults: Effects of Esmolol Infusion. Trials, record NCT04181606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04181606
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Age Comparisons of Exercising Muscle O2 Supply in Healthy Adults: Effects of Esmolol Infusion
- NCT number
- NCT04181606
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- David N. Proctor, PhD
- Conditions
- Aging
- Interventions
- Esmolol infusion, Saline infusion, Pre exercise baseline, Isometric handgrip exercise, Semi-recumbent cycling
- First posted
- 2019-11-29
- Last updated
- 2025-05-13
- Results first posted
- 2025-05-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tissue Saturation Index (TSI) - Active Leg Muscle | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | The primary outcome variable is the change in skeletal muscle oxygenation (∆TSI%) in the active leg muscle from baseline during recumbent cycling using near-infrared spectroscopy. TSI% represent the percentage of oxygenated hemoglobin relative to total hemoglobin in the tissue beneath the NIRS probe. Lower values represent a greater reduction in tissue oxygenation from baseline (greater oxygen extraction and/or reduced oxygen delivery). TSI% = oxy\[heme\] / total\[heme\] x 100 |
| Secondary | Tissue Saturation Index - Inactive Forearm Muscle | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | The change in skeletal muscle oxygenation (∆TSI%) in the inactive forearm from baseline during recumbent cycling using near-infrared spectroscopy. TSI% represent the percentage of oxygenated hemoglobin relative to total hemoglobin in the tissue beneath the NIRS probe. Lower values represent a greater reduction in tissue oxygenation from baseline (greater oxygen extraction and/or reduced oxygen delivery). TSI% = oxy\[heme\] / total\[heme\] x 100 |
| Secondary | Systolic Blood Pressure | At rest and 3 minutes into moderate exercise and heavy exercise. | Systolic Blood Pressure recorded via an automatic sphygmomanometer (SunTech Tango) |
| Secondary | Heart Rate | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | Heart rate recorded via EKG |
| Secondary | Cardiac Output | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | Cardiac Output recorded using bioimpedance cardiography |
| Secondary | Diastolic Blood Pressure | At rest and 3 minutes into moderate exercise and heavy exercise. | Diastolic Blood Pressure recorded via an automatic sphygmomanometer (SunTech Tango) |
| Secondary | Mean Arterial Pressure | At rest and 3 minutes into moderate exercise and heavy exercise. | Mean Arterial Pressure recorded via an automatic sphygmomanometer (SunTech Tango) |
| Secondary | Stroke Volume | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | Stroke Volume recorded using bioimpedance cardiography |
| Secondary | Systemic Vascular Conductance | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | Systemic Vascular Conductance recorded using bioimpedance cardiography |
| Secondary | ∆HHb - Inactive Forearm | Last 60 seconds of Moderate and Heavy Exercise | Change in deoxygenated hemoglobin (∆HHb) in the inactive forearm muscle from baseline during recumbent cycling exercise using near-infrared spectroscopy (NIRS) relative to the Total Labile Signal. ∆HHb is an index of oxygen extraction obtained using NIRS. The total labile signal is defined as the difference between the highest observed HHb value during 5 minutes of limb occlusion at 250 mmHg and the lowest observed HHb value observed during reperfusion following removal of the occlusion. Greater ∆HHb values indicate greater oxygen extraction in the tissue under the NIRS probe. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tissue Saturation Index (TSI) - Active Leg Muscle | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | 11 younger and 12 older at two different exercise intensities (Moderate and Heavy) | % Total Labile Signal | MEAN |
| SECONDARY | Tissue Saturation Index - Inactive Forearm Muscle | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | 11 younger, 11 older | % Total Labile Signal | MEAN |
| SECONDARY | Systolic Blood Pressure | At rest and 3 minutes into moderate exercise and heavy exercise. | 13 younger, 13 older | mmHg | MEAN |
| SECONDARY | Heart Rate | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | 13 Younger, 14 Older | Beats/minute | MEAN |
| SECONDARY | Cardiac Output | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | 13 younger, 13 older | Liters/minute | MEAN |
| SECONDARY | Diastolic Blood Pressure | At rest and 3 minutes into moderate exercise and heavy exercise. | 13 younger, 13 older | mmHg | MEAN |
| SECONDARY | Mean Arterial Pressure | At rest and 3 minutes into moderate exercise and heavy exercise. | 13 younger, 13 older | mmHg | MEAN |
| SECONDARY | Stroke Volume | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | 13 younger, 13 older | mL/beat | MEAN |
| SECONDARY | Systemic Vascular Conductance | Last 60 seconds of Rest, Moderate exercise, and Heavy Exercise. | 13 younger, 13 older | mL/minute/mmHg | MEAN |
| SECONDARY | ∆HHb - Inactive Forearm | Last 60 seconds of Moderate and Heavy Exercise | 9 younger, 12 older | % Total Labile Signal | MEAN |
Source ClinicalTrials.gov
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tissue Saturation Index (TSI) - Active Leg Muscle | Esmolol Infusion | Younger - Moderate | -5.1 | Standard Deviation 3.2 | % Total Labile Signal |
| Tissue Saturation Index (TSI) - Active Leg Muscle | Saline Infusion | Younger - Moderate | -3.1 | Standard Deviation 2.4 | % Total Labile Signal |
| Tissue Saturation Index (TSI) - Active Leg Muscle | Esmolol Infusion | Younger - Heavy | -8.7 | Standard Deviation 3.5 | % Total Labile Signal |
| Tissue Saturation Index (TSI) - Active Leg Muscle | Saline Infusion | Younger - Heavy | -6.3 | Standard Deviation 3.6 | % Total Labile Signal |
| Tissue Saturation Index (TSI) - Active Leg Muscle | Esmolol Infusion | Older - Moderate | -1.5 | Standard Deviation 0.9 | % Total Labile Signal |
| Tissue Saturation Index (TSI) - Active Leg Muscle | Saline Infusion | Older - Moderate | -0.5 | Standard Deviation 1.1 | % Total Labile Signal |
| Tissue Saturation Index (TSI) - Active Leg Muscle | Esmolol Infusion | Older - Heavy | -4.1 | Standard Deviation 2.7 | % Total Labile Signal |
| Tissue Saturation Index (TSI) - Active Leg Muscle | Saline Infusion | Older - Heavy | -2.8 | Standard Deviation 3.2 | % Total Labile Signal |
| Tissue Saturation Index - Inactive Forearm Muscle | Esmolol Infusion | Younger - Moderate | -3.3 | Standard Deviation 2.5 | % Total Labile Signal |
| Tissue Saturation Index - Inactive Forearm Muscle | Saline Infusion | Younger - Moderate | -1.3 | Standard Deviation 1.6 | % Total Labile Signal |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (up to 1 Hour) | STARTED | Esmolol, Then Saline | 13 | |
| First Intervention (up to 1 Hour) | STARTED | Saline, Then Esmolol | 14 | |
| First Intervention (up to 1 Hour) | COMPLETED | Esmolol, Then Saline | 13 | |
| First Intervention (up to 1 Hour) | COMPLETED | Saline, Then Esmolol | 14 | |
| First Intervention (up to 1 Hour) | NOT COMPLETED | Esmolol, Then Saline | 0 | |
| First Intervention (up to 1 Hour) | NOT COMPLETED | Saline, Then Esmolol | 0 | |
| Washout (45 Mins) | STARTED | Esmolol, Then Saline | 13 | |
| Washout (45 Mins) | STARTED | Saline, Then Esmolol | 14 | |
| Washout (45 Mins) | COMPLETED | Esmolol, Then Saline | 13 | |
| Washout (45 Mins) | COMPLETED | Saline, Then Esmolol | 14 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esmolol | 0 | 27 |
| Total, all-cause mortality | Saline | 0 | 27 |
| Total, other adverse events | Esmolol | 0 | 27 |
| Total, other adverse events | Saline | 0 | 27 |
| Total, serious adverse events | Esmolol | 0 | 27 |
| Total, serious adverse events | Saline | 0 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esmolol vs Saline: deaths from any cause | Trial comparisons |
| Esmolol vs Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04181606
GET https://conductscience.org/api/trials/v1/NCT04181606/results?page=2