Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit

NCT03648762 | Completed Results

• 1 other identifier: O0834-R
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to better understand how exercise training in older adults (≥65 years) with heart failure (HF) affects skeletal muscle both intrinsically and in respect to its impact on functional capacity. While many conceptualize HF as a pathophysiology that exclusively affects the heart, skeletal muscle atrophy and weakening are also elemental to the disease. While reduced exercise capacity is typically associated with HF, this may be related more to disease effects in skeletal muscle than the heart. This is a clinical study that focuses on exercise training which compares functional endpoints before and after training. Patients are randomized to one of three exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory muscle training) for 12 weeks and are assessed pre- and post-training to determine if any differences occur in their skeletal muscle and functional capacity. Skeletal muscle biopsies before and after the exercise training intervention in order to study changes in skeletal muscle histology and biology. Functional endpoints in this study include ventilatory gas indices from cardiopulmonary exercise testing, lower body strength testing, grip strength, sit-to-stand, six-minute-walk distance, gait speed, inspiratory muscle strength, and quality of life and physical activity-oriented questionnaires, including the Kansas City Cardiomyopathy Questionnaire, Duke Activity Status Index, and CHAMPS Physical Activity Questionnaire for Older Adults. Body composition is measured with Dual Energy X-ray (DXA) scanning. Skeletal muscle biopsies are completed in the vastus lateralis of the non-dominant leg to assess histology and biologic endpoints.

Conditions

Heart Failure

Keywords

Heart failure; Exercise; Cardiopulmonary

Outcome Measures

Primary Outcomes (2)

• Oxygen Uptake (VO2) Peak

  a cardiopulmonary exercise test will be performed to determined peak VO2 in ML/KG/Min

  baseline and through study completion an average of 14 weeks

• One Repetition Maximum- Leg Press

  Leg press will be performed on the Keiser Leg press and measured in kilograms (kg)

  baseline and through study completion an average of 14 weeks

Secondary Outcomes (5)

• Metabolomics

  baseline and through study completion an average of 14 weeks

• Skeletal Muscle Gene Expression

  baseline and through study completion an average of 14 weeks

• Quality of Life and Daily Function Questionnaires

  baseline and through study completion an average of 12 weeks

• Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Frequency Component

  baseline and through study completion an average of 12 weeks

• Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Duration Component

  baseline and through study completion an average of 12 weeks

Other Outcomes (2)

• Inflammation - C-reactive Protein

  baseline and through study completion an average of 14 weeks

• Dual-energy X-ray Absorptiometry

  Baseline and through study completion an average of 14 weeks

Study Arms (3)

Aerobic Exercise Intervention

OTHER

12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise

Behavioral: Aerobic Exercise Intervention

Combined Aerobic and Strength Exercise Intervention

OTHER

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

Behavioral: Combined Aerobic and Strength Exercise Intervention

Inspiratory Muscle Training Exercise Intervention

OTHER

12 weeks of a minimum of 3 days a week for 60 minutes of Inspiratory Muscle Training Exercise

Behavioral: Inspiratory Muscle Training Exercise Intervention

Interventions

Aerobic Exercise Intervention BEHAVIORAL

Aerobic Exercise Intervention - 12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise

Aerobic Exercise Intervention

Combined Aerobic and Strength Exercise Intervention BEHAVIORAL

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

Combined Aerobic and Strength Exercise Intervention

Inspiratory Muscle Training Exercise Intervention BEHAVIORAL

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

Inspiratory Muscle Training Exercise Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Daniel E. Forman, MD
• Organization: VA Pittsburgh Healthcare System

Daniel.Forman@va.gov

(412) 360-2917

Study Officials

• Daniel E. Forman, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: May 8, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)