A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
1 other identifier
interventional
42
1 country
1
Brief Summary
The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Jun 2021
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 14, 2021
CompletedFirst Posted
Study publicly available on registry
July 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 16, 2025
July 1, 2025
5 years
June 14, 2021
July 14, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Blood pressure response
Mean arterial pressure
baseline and 12 week follow up
Change in blood flow response
respiratory muscle blood flow
baseline and 12 week follow up
Change in limb vascular resistance response
Limb vascular resistance
baseline and 12 week follow up
Study Arms (2)
Sham arm
SHAM COMPARATORPerform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.
Non-sham arm
ACTIVE COMPARATORPerform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
Interventions
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure
Eligibility Criteria
You may qualify if:
- Adult 18 years and older.
- English speaking.
- Has a qualifying heart failure indication for center-based cardiac rehabilitation.
- Adult 18 years and older.
- English speaking.
- Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex.
You may not qualify if:
- 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.
- Uremia, history of allergy to iodides. Impaired renal function.
- Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months).
- Diagnosis of liver disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Smith, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 14, 2021
First Posted
July 30, 2021
Study Start
June 1, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 16, 2025
Record last verified: 2025-07