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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
Healthy Control Group: Adult 18 years and older. English speaking. Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex.
Heart Failure Group: Adult 18 years and older. English speaking. Has a qualifying heart failure indication for center-based cardiac rehabilitation.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18, speak English, and don't have major health issues.
Select...
I am an adult with heart failure and qualify for cardiac rehab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 week follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 week follow up for reporting.

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,469 Total Patients Enrolled
72 Trials studying Heart Failure
1,022,024 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

Non-sham arm Clinical Trial Eligibility Overview. Trial Name: NCT04984473 — N/A
Heart Failure Research Study Groups: Sham arm, Non-sham arm
Heart Failure Clinical Trial 2023: Non-sham arm Highlights & Side Effects. Trial Name: NCT04984473 — N/A
Non-sham arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984473 — N/A

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
~2 spots leftby Jun 2024