High Intensity Interval Exercise in Diastolic Heart Failure

NCT02147613 | Completed Results

• 1 other identifier: Mayo-ArizonaSU Seed 93016001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

Heart failure is a major health concern and is the leading cause of hospitalization among elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and the estimated direct and indirect costs of treating heart failure are approximately $37.2 billion. Approximately 40% of those diagnosed with heart failure will have heart failure with preserved ejection fraction (HFPEF). These individuals have significant restrictions in their ability to carry out activities of daily living. Exercise training has been established as adjuvant therapy in heart failure. Although exercise training guidelines for treatment of heart failure with reduced ejection fraction (HFREF) are well established, no consensus exercise guidelines exist for management of HFPEF. Aerobic and cardiovascular adaptations are generally greater after high-intensity exercise training; interval-type exercise facilitates this type of training because it allows for rest periods that make it possible for patients with heart failure to perform short (e.g., 1-4 minutes) work periods at intensities that are higher than would be possible during continuous exercise. High-intensity aerobic interval training presents a unique, yet untested, therapeutic modality for the exercise training of patients with heart failure with preserved ejection fraction. Pilot testing is warranted, results of which may have important implications for reducing cardiovascular risk, increasing short- and long-term quality of life and survival, and reducing healthcare costs in this patient population. The investigators primary specific aim is to determine the efficacy of a novel, high-intensity aerobic interval exercise training program for improving VO2peak (peak oxygen uptake), endothelial function, and arterial stiffness in patients with HFPEF. The investigators secondary aim is to determine whether the vascular changes are correlated with the changes in VO2peak.

Conditions

Diastolic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Diastolic Dysfunction

  Measured using left ventricular echocardiography. Diastolic dysfunction is graded as: normal, grade 1, grade 2, grade 3, grade 4. Increasing grade is indicative of worsening LV dysfunction and worse outcomes. Improvement in LV grade is associated with better long term outcomes.

  Before and after the 1 month exercise intervention

Secondary Outcomes (1)

• VO2peak

  Test carried out before and after the 1 month long exercise intervention.

Other Outcomes (1)

• Brachial Artery Flow-mediated Dilation

  Before and after 1-month exercise intervention

Study Arms (2)

High intensity interval training

EXPERIMENTAL

High intensity interval training - 3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)

Other: High intensity interval training

Moderate intensity exercise training

ACTIVE COMPARATOR

3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)

Other: Moderate intensity exercise training

Interventions

High intensity interval training OTHER

3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)

High intensity interval training

Moderate intensity exercise training OTHER

3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)

Moderate intensity exercise training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HFpEF diagnosis with New York Heart Association heart failure Class II-III symptoms

You may not qualify if:

• Unstable angina
• Myocardial infarction in the past 4 weeks
• Uncompensated heart failure
• New York Heart Association class IV symptoms
• Complex ventricular arrhythmias (at rest or during the maximal exercise test)
• Medical or orthopedic conditions that precluded treadmill walking
• Symptomatic severe aortic stenosis
• Acute pulmonary embolus
• Acute myocarditis
• Medication non-compliance

Sponsors & Collaborators

• Arizona State University: lead
• Mayo Clinic: collaborator
• University of Alberta: collaborator

Study Sites (2)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

• Angadi SS, Mookadam F, Lee CD, Tucker WJ, Haykowsky MJ, Gaesser GA. High-intensity interval training vs. moderate-intensity continuous exercise training in heart failure with preserved ejection fraction: a pilot study. J Appl Physiol (1985). 2015 Sep 15;119(6):753-8. doi: 10.1152/japplphysiol.00518.2014. Epub 2014 Sep 4.

  PMID: 25190739 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Siddhartha S. Angadi, PhD., FACSM
• Organization: Arizona State University - Downtown Phoenix Campus

sangadi@asu.edu

6028272254

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 28, 2014
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-01

Locations

US (2)