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Behavioural Intervention

Inspiratory Muscle Training vs Aerobic Exercise for High Blood Pressure

N/A

Recruiting

Led By Douglas R Seals, PhD

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No change in blood pressure medications or other medications (prescription or dosing) in the prior 3 months and willing to maintain current medication regimen

Postmenopausal women (>12 months of amenorrhea)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is looking at the effects of high-resistance inspiratory muscle strength training (IMST) on blood pressure and endothelial function in postmenopausal women.

Who is the study for?

This trial is for postmenopausal women aged 50 or older with high blood pressure (systolic BP ≥120 mmHg). Participants should not be on hormone therapy, have a BMI under 40, and must not have had significant weight changes or medication adjustments recently. They shouldn't smoke, abuse alcohol, or engage in regular intense exercise.Check my eligibility

What is being tested?

The study compares the effects of high-resistance inspiratory muscle strength training (IMST) versus standard aerobic exercise like brisk walking on lowering blood pressure and improving vascular health in postmenopausal women over three months.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include muscle fatigue from IMST and typical exercise-related risks such as joint strain from brisk walking. The safety profile will likely be clarified during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't changed my blood pressure or any other medications in the last 3 months and am willing to keep them the same.

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I am a woman who has not had a period for over 12 months.

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I am 50 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in casual systolic and diastolic blood pressure at 3 months

Secondary outcome measures

Change from baseline endothelial function at 3 months

Change from baseline in ambulatory systolic and diastolic blood pressure at 3 months

Other outcome measures

Adherence to the intervention

Change from baseline in endothelial cell nitric oxide production at 3 months

Change from baseline in endothelial cell oxidative stress at 3 months

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High-resistance inspiratory muscle strength trainingExperimental Treatment1 Intervention

Using a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for three months.

Group II: Aerobic exerciseActive Control1 Intervention

Participants will walk for 25 minutes a day, six days a week, for three months at a target heart rate of 40-60% heart rate reserve. Heart rate will be monitored with a heart rate monitor.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

University of Colorado, BoulderLead Sponsor

119 Previous Clinical Trials

29,104 Total Patients Enrolled

Douglas R Seals, PhDPrincipal InvestigatorUniversity of Colorado, Boulder

7 Previous Clinical Trials

573 Total Patients Enrolled

Media Library

High-resistance inspiratory muscle strength training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05000515 — N/A

High Blood Pressure Research Study Groups: High-resistance inspiratory muscle strength training, Aerobic exercise

High Blood Pressure Clinical Trial 2023: High-resistance inspiratory muscle strength training Highlights & Side Effects. Trial Name: NCT05000515 — N/A

High-resistance inspiratory muscle strength training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05000515 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this clinical exploration?

"According to the clinicaltrials.gov database, this medical trial is actively recruiting patients and has been since it was first published on February 4th 2022. Most recently, data pertaining to the study was updated on June 6th 2022."

Answered by AI

What is the current enrollment volume of this clinical experiment?

"Affirmative. As per the information available on clinicaltrials.gov, this medical examination has been accepting applicants since February 4th 2022 and the most recent update was provided in June 6th 2022. The trial requires 90 patients to be enrolled across a single centre."

Answered by AI