Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit (EXT-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648762
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

The purpose of this research study is to better understand how skeletal muscle is affected by heart failure, and to determine how exercise interventions impact skeletal muscle and functional capacity. While many think of heart failure as a disease that only affects the heart, doctors now believe that it actually affects the whole body, including skeletal muscle, such as the muscles of your arms and legs. Therefore, while many people with heart failure develop weakness and reduced exercise capacity, this may be related more to their skeletal muscle than their weakened hearts. This study looks directly at how exercise might change skeletal muscle and possibly improve quality of life in heart failure patients.

As part of the study participants will take part in a cardiopulmonary exercise test, lower body strength testing, breathing assessment, a muscle biopsy (optional), blood draw, and DXA scanning (to assess lean body mass). Participants with heart failure will complete 1 of 3 exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory) for 12 weeks and will be assessed pre and post to determine if any differences occur in their skeletal muscle and functional capacity as part of the exercise intervention.


Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Aerobic Exercise Intervention Behavioral: Combined Aerobic and Strength Exercise Intervention Behavioral: Inspiratory Muscle Training Exercise Intervention Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Participants with heart failure will complete 1 of 3 exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory) for 12 weeks and will be assessed pre and post to determine if any differences occur in their skeletal muscle and functional capacity as part of the exercise intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Heart failure patients
Patients diagnosis with heart failure will be assessed for the study
Behavioral: Aerobic Exercise Intervention
Aerobic Exercise Intervention - 12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise

Behavioral: Combined Aerobic and Strength Exercise Intervention
Combined Aerobic and Strength Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Combined Aerobic and Strength Exercise

Behavioral: Inspiratory Muscle Training Exercise Intervention
Inspiratory Muscle Training Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Inspiratory Muscle Training Exercise




Primary Outcome Measures :
  1. Oxygen uptake (VO2) peak [ Time Frame: baseline and through study completion an average of 14 weeks ]
    a cardiopulmonary exercise test will be performed to determined peak VO2 in ML/KG/Min

  2. One Repetition Maximum- Leg press [ Time Frame: baseline and through study completion an average of 14 weeks ]
    Leg press will be performed on the Keiser Leg press and measured in kilograms (kg)


Secondary Outcome Measures :
  1. Gene Expression - proteolytic genes (Forkhead box O3 [Foxo3] and Ubiquitin) [ Time Frame: baseline and through study completion an average of 14 weeks ]
    Assessment of proteolytic genes (Forkhead box O3 [Foxo3] and Ubiquitin) through assessment real-time -polymerase chain reaction of skeletal muscle biopsy measured in relative expression.

  2. Gene Expression anabolic genes Peroxisome proliferator-activated receptor gamma coactivator 1-alpha and Insulin-like growth factor 1 [ Time Frame: baseline and through study completion an average of 14 weeks ]
    Gene Expression anabolic genes Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1 ) and Insulin-like growth factor 1 (IGF-1) through assessment real-time -polymerase chain reaction of skeletal muscle biopsy measured in relative expression.


Other Outcome Measures:
  1. Inflammation - C-reactive protein [ Time Frame: baseline and through study completion an average of 14 weeks ]
    Inflammation - C-reactive protein will be measured through blood

  2. dual-energy x-ray absorptiometry [ Time Frame: Baseline and through study completion an average of 14 weeks ]
    dual-energy x-ray absorptiometry will look at muscle mass change in kg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Heart failure
  • Echo in two years
  • NYHA class II or III
  • Optimal therapy according to AHA/ACC and HFSA HF guidelines; unless documented by a provider for variation.

Exclusion Criteria:

  • Major cardiovascular event or procedure within the prior 6 weeks.
  • Dementia
  • Severe COPD (FEV1<50%),
  • End-stage malignancy
  • Severe valvular heart disease that would make exercise un safe
  • Orthopedic limitation preventing exercise
  • Any bleeding disorder that would contraindicate safe exercise
  • Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months
  • Psychiatric hospitalization within the last 3 months
  • ICD device with heart rate limits that prohibit exercise assessments or exercise training.

    • Referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
  • Chronic use of oral corticosteroids or medications that affect muscle function.

    • Notably, patients using statins will be eligible, and this will be factored into the randomization and analysis.
  • Chronic ETOH or drug dependency shown within the last year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648762


Locations
Layout table for location information
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Daniel E. Forman, MD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03648762    
Other Study ID Numbers: O0834-R
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Heart failure
Exercise
Cardiopulmonary
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases