Resistance Training in HFpEF

Heart Failure Preserved Ejection Fraction Clinical Trial

Official title:

Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435667
• Other study ID #: 15-000320
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 2021

Study information

• Verified date: February 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).

Description:

In this randomized controlled pilot study of resistance exercise training in patients with HFpEF, the investigators will recruit 24 HFpEF patients who will be randomized to resistance exercise training (RT - n=12) or no resistance exercise training (standard care control group [CTL] - n=12). The investigators will have baseline and follow-up measures of clinical characteristics, leg muscle strength, quality of life, lean muscle mass (body composition via DXA including segmental lean mass), maximal cardiopulmonary exercise test (peak VO2, peak work, ventilatory efficiency), constant-load submaximal cardiopulmonary exercise test with speckle tracking echocardiography (exertional dyspnea and fatigue at matched workloads, cardiac output, diastolic function, left ventricular strain, ventilation, gas exchange, and locomotor muscle neural feedback). Participants will be asked to make 4 separate study visits. Those randomized to undergo Resistance Training will be expected to make those visits as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

All patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and exclusion criteria and that participation in exercise testing and resistance exercise training is safe.

Inclusion Criteria, includes:

• Clinical diagnosis of HFpEF.
• Patients 18-80 yrs old with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis >6 months).
• New York Heart Association class I-III.
• Ejection fraction =40%.
• 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).

Exclusion Criteria, includes:

• Patient refusal to participate.
• Significant orthopedic or neuromuscular limitations
• Significant cognitive impairment
• Hemoglobin < 7.0 g/d.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Preserved Ejection Fraction

Intervention

Other:
• Resistance Exercise Training
Aerobic Exercise a. Each participant will engage in 5 minutes of aerobic based exercise on an arm/leg ergometer (NuStep Cross Trainer) at an intensity of 12-14 on the Borg Rating of Perceived Exertion Scale as a warm-up prior to the exercise session and again as a cool-down at the end of the exercise session. Resistance Exercise - 2 sets of 8-12 repetitions - beginning at 60% of the initial 1 RM. a) Leg Extension, b) Bicep Curl, c) Leg Press, d) Chest Press, e) Leg Curl, f)Seated Row (horizontal or pulldown), g) Calf Raises Core Strengthening Exercises a. 5-10 minutes of stability ball and balance exercises

Radiation:
• DEXA bone scan
A DEXA scan that provides bone density measures.

Other:
• Cardiopulmonary Max Exercise Test
Pedaling on a cycle ergometer to volitional fatigue.
• Quality of Life Questionnaire
A 10 minute questionnaire that measures quality of life.
• Submaximal Exercise Test
Two short submaximal constant-load exercise sessions at 20 Watts. Each session will include 6 minutes of cycling (baseline). Following baseline, the sessions will be randomized to continued constant-load cycling for an additional 9 minutes (for echocardiographic measures) or randomized sub-systolic inflation of bilateral thigh pressure tourniquets to 40 and 80 mmHg for 3 minutes with 3 minutes of deflation between inflations to stimulate locomotor muscle neural feedback.
• Blood Draw
A blood draw amounting to 1 teaspoon of blood drawn.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density and strength	DEXA scan	12 weeks
Primary	Cardiopulmonary Function	Cardiopulmonary bike exercise	12 weeks
Primary	Quality of Life	Questionnaire	12 weeks
Primary	Blood Biomarkers	Blood draw	12 weeks

External Links

•   Mayo Clinic Clinical Trials