Back to resultsA Study to Evaluate Breathing Muscle Training in Cardiac Rehab
Primary Purpose
Healthy, Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
About this trial
This is an interventional other trial for Healthy
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.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham arm
Non-sham arm
Arm Description
Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.
Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
Outcomes
Primary Outcome Measures
Blood pressure response
Mean arterial pressure
Change in blood flow response
respiratory muscle blood flow
Change in limb vascular resistance response
Limb vascular resistance
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04984473
Brief Title
A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
Official Title
Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Heart Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham arm
Arm Type
Sham Comparator
Arm Description
Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.
Arm Title
Non-sham arm
Arm Type
Active Comparator
Arm Description
Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure
Primary Outcome Measure Information:
Title
Blood pressure response
Description
Mean arterial pressure
Time Frame
baseline and 12 week follow up
Title
Change in blood flow response
Description
respiratory muscle blood flow
Time Frame
baseline and 12 week follow up
Title
Change in limb vascular resistance response
Description
Limb vascular resistance
Time Frame
baseline and 12 week follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Bruhn, MA
Phone
507-266-2690
Email
bruhn.eric@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Smith
Email
smith.joshua1@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Olson, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Olson, PhD
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
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