An interventional study of Inspiratory muscle strength training and Sham training in Hypertension, Prehypertension and Aging, sponsored by Douglas Seals. Completed at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-07.
Sponsored by Douglas Seals · Not applicable, Interventional, and Treatment
Among 2,029 studies in Hypertension with a site in United States — 273 open to participants now, 369 under way, 16 of them phase 3. Hypertension · United States.
Among the 2,029 studies in Hypertension with a site in United States, this one is the 1,043rd largest by enrollment of the 1,777 interventional ones that give a count, is one of 80 that started in 2017, is one of 1,069 with no phase, and was the 1,138th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
Browse Hypertension studies →273 of the 2,029 studies in Hypertension with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt University Medical Center · Sites in United States
University of California, San Francisco · Sites in United States
University of Alabama at Birmingham · Sites in United States
The University of Texas at Arlington · Sites in United States
University of Washington · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 50 Years to 64 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,029 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 147 · Phase 2 216 · Phase 3 214 · Phase 4 188
First in 1973; this study’s year is marked. 80 started in 2017.
This study's enrollment of 64 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Median enrollment 100 across the 1,777 interventional studies, 200 across the 238 observational. Of the 1,511 that completed or were terminated, 577 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
461 of 2,029 have an industry lead sponsor. The 10 most frequent:
Douglas Seals is the lead sponsor of 3 studies on the registry; none are open to participants now.
Douglas Seals has 2 studies filed under Hypertension — fewer than ten, so there is no comparison to draw.
142 of the studies in Hypertension with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT04971720Phase 3University of Alabama at BirminghamPRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis | 2027-01-01 |
| NCT06948422Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening) | 2027-09 |
| NCT06948435Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 | 2027-09 |
| NCT06952530Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2 | 2027-09 |
Among the 2,029 studies in Hypertension with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the efficacy of inspiratory muscle strength training for lowering blood pressure and improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults with elevated systolic blood pressure.
Over, the proposed research project has the long-term potential to influence clinical practice by establishing a novel lifestyle intervention for treating multiple domains of age- and hypertension-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be strong.
Other: Inspiratory muscle strength training
Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be weak.
Other: Sham training
Subjects will perform inspiratory muscle strength training for 6 weeks.
Subjects will perform sham training for 6 weeks.
Blood pressure
Resting blood pressure
Time frame: 6 weeks
Ambulatory blood pressure
24-hour mean blood pressure
Time frame: 6 weeks
Endothelium-dependent dilation
Flow-mediated dilation
Time frame: 6 weeks
Arterial stiffness
Aortic pulse wave velocity
Time frame: 6 weeks
Motor function
NIH Toolbox motor test battery
Time frame: 6 weeks
Cognitive function
NIH Toolbox cognition test battery
Time frame: 6 weeks
Systemic markers of oxidative stress
Oxidized LDL levels in blood
Time frame: 6 weeks
Endothelial cell markers of oxidative stress
Nitrotyrosine levels in biopsied endothelial cells
Time frame: 6 weeks
Plan to share: No
Ran from Nov 2017 to primary completion in Apr 2020, 28 months.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 28 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Douglas Seals