Respiratory Muscle Function in Heart Failure

NCT03924479 | Completed

• 1 other identifier: 17-007785
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done because investigators are trying to determine how respiratory muscle and lung function influence the exercise responses in heart failure and healthy participants. Further, the heart failure patients will participate in an intervention to improve their respiratory muscle function to determine if this improves exercise capacity.

Conditions

Heart Failure, Diastolic

Keywords

heart failure preserved ejection fraction; exercise; respiratory muscle

Outcome Measures

Primary Outcomes (6)

• Breathing muscle oxygen cost

  Breathing muscle oxygen uptake between heart failure and healthy participants

  Year 1

• Respiratory muscle blood flow

  Breathing muscle blood flow between heart failure and healthy participants

  Year 1

• Systolic and diastolic blood pressure

  Respiratory muscle workout-induced increases in systolic and diastolic blood pressure between heart failure and healthy participants

  Year 1

• Breathing muscle oxygen cost

  Breathing muscle oxygen uptake from pre to post-breathing muscle training in heart failure participants

  Year 2

• Respiratory muscle blood flow

  Breathing muscle blood flow rom pre to post-breathing muscle training in heart failure participants

  Year 2

• Systolic and diastolic blood pressure

  Respiratory muscle workout-induced increases in systolic and diastolic blood pressure from pre to post-breathing muscle training in heart failure participants

  Year 2

Study Arms (2)

Breathing muscle training

EXPERIMENTAL

The breathing muscle training will consist of 7 sessions per week (1 per day) for 8 weeks. Each training session will consist of breathing \~15 times each minute for 30 minutes at 40% of maximal breathing muscle strength, while using the breathing muscle trainer. During the inhalation, participants will be instructed to inhale as fast as they can, while exhalations will be performed at the participants discretion.

Device: PowerBreathe (Breathing muscle training)

Sham breathing muscle training

SHAM COMPARATOR

The breathing muscle training will consist of 7 sessions per week (1 per day) for 8 weeks. Each training session will consist of breathing \~15 times each minute for 30 minutes at 2%% of maximal breathing muscle strength, while using the breathing muscle trainer. During the inhalation, participants will be instructed to inhale as fast as they can, while exhalations will be performed at the participants discretion.

Device: PowerBreathe (Breathing muscle training)

Interventions

PowerBreathe (Breathing muscle training) DEVICE

The breathing muscle breathing training will consist of using the PowerBreathe training for 8 weeks. The PowerBreathe is an inspiratory pressure threshold trainer.The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device.

Also known as: PowerBreathe Device

Breathing muscle training; Sham breathing muscle training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Clinical diagnosis of HFpEF.
• Patients with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis \>6 months).
• New York Heart Association class I-III.
• Current non-smokers with \<15 pack year history.
• Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).
• history of dangerous arrhythmias
• body mass index \>35 kg/m2
• current smokers and/or smoking history \>15 pack years
• pregnant women
• uremia, history of allergy to iodides
• impaired renal function
• creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the past 6 months)
• diagnosis of liver disease
• individuals who are not able to engage in exercise

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure, Diastolic; Motor Activity

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Thomas P Olson

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: February 4, 2019
• First Posted: April 23, 2019
• Study Start: November 28, 2018
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)