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Breathing Muscle Training for Heart Rehabilitation

N/A
Recruiting
Led By Joshua Smith, 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
Must not have
HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program.
Participants unable/unwilling to provide informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 week follow up

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.
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.
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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have heart failure and can't participate in a structured exercise program.
Select...
I am able and willing to give informed consent.
Select...
I have kidney problems or am allergic to iodides.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
3,332 Previous Clinical Trials
3,059,869 Total Patients Enrolled
75 Trials studying Heart Failure
26,157 Patients Enrolled for Heart Failure
Joshua Smith, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
68 Total Patients Enrolled
1 Trials studying Heart Failure
68 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
~5 spots leftby Jun 2025
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