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Breathing Muscle Training for Heart Rehabilitation
N/A
Recruiting
Led By Thomas Olson, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 week follow up
Awards & highlights
Study Summary
This trial looks at the effects of adding extra breathing exercises to cardiac rehabilitation on blood flow and blood pressure during exercise.
Who is the study for?
This trial is for adults over 18 who speak English. There are two groups: one with heart failure patients eligible for cardiac rehab, and a healthy control group without lung, heart, or other major diseases. Participants must be able to exercise and give consent. Those with liver disease, uremia, iodide allergies, or poor kidney function (creatinine >1.3 mg/dL) can't join.Check my eligibility
What is being tested?
The study tests if breathing muscle training improves blood flow and pressure during exercise when added to standard cardiac rehabilitation in people with heart failure compared to healthy individuals matched by age and sex.See study design
What are the potential side effects?
While the document doesn't list specific side effects of inspiratory muscle training, it's generally considered safe but may include temporary breathlessness or fatigue during the exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 week follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 week follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure response
Change in blood flow response
Change in limb vascular resistance response
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Non-sham armActive Control1 Intervention
Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
Group II: Sham armPlacebo Group1 Intervention
Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,233 Previous Clinical Trials
3,771,784 Total Patients Enrolled
72 Trials studying Heart Failure
1,021,986 Patients Enrolled for Heart Failure
Thomas Olson, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Heart Failure
28 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, speak English, and don't have major health issues.I have heart failure and can't participate in a structured exercise program.I am able and willing to give informed consent.I have kidney problems or am allergic to iodides.I am an adult with heart failure and qualify for cardiac rehab.I have been diagnosed with liver disease.Your kidney test showed a creatinine level higher than 1.3 mg/dL in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Sham arm
- Group 2: Non-sham arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a current call for participants in this experiment?
"Affirmative, the information available on clinicaltrials.gov attests that this experiment is actively seeking participants. Originally posted on June 1st 2021 and most recently edited July 21st 2022, it seeks to recruit 42 patients at a single location."
Answered by AI
What is the aggregate enrollment figure for this experiment?
"Affirmative. Per the information on clinicaltrials.gov, this research is actively looking for participants to join their study. This trial was first published on June 1st 2021 and recently updated July 21st 2022; 42 patients are needed at a single site of enrollment."
Answered by AI
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