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A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04984473
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
28
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Inspiratory muscle training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham arm

Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.

Device: Inspiratory muscle training
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure
Active Comparator: Non-sham arm

Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.

Device: Inspiratory muscle training
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure

Outcome Measures

Primary Outcome Measures

  1. Blood pressure response [baseline and 12 week follow up]

    Mean arterial pressure

  2. Change in blood flow response [baseline and 12 week follow up]

    respiratory muscle blood flow

  3. Change in limb vascular resistance response [baseline and 12 week follow up]

    Limb vascular resistance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Thomas Olson, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Thomas P. Olson, M.S., Ph.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04984473
Other Study ID Numbers:
  • 20-009490
First Posted:
Jul 30, 2021
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jul 25, 2022