Recruiting NCT04984473
A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inspiratory muscle training.
- Who it may be relevant to
- Registry conditions: Healthy, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
Overview
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.
Interventions
- Device Inspiratory muscle training
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure
Primary outcome measures
- Blood pressure response [Time frame: baseline and 12 week follow up]
- Change in blood flow response [Time frame: baseline and 12 week follow up]
- Change in limb vascular resistance response [Time frame: baseline and 12 week follow up]
Eligibility criteria
Inclusion Criteria - Heart Failure Group:
- Adult 18 years and older.
- English speaking.
- Has a qualifying heart failure indication for center-based cardiac rehabilitation.
Inclusion Criteria - 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04984473 · 20-009490