Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction

Isometric Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: a Randomised Controlled Study

Heart failure with a preserved ejection fraction (HFpEF) is a major cause of morbidity and mortality. Hypertension remains one of the major modifiable risk factors in HFpEF development and progression. The role of aerobic exercise training for blood pressure (BP) reduction is well established, with positive cardiac, vascular, and neurohumoral adaptations all cited as potential mechanisms for improving arterial haemodynamics. However, recent evidence has shown that a specific type of resistance exercise alone, known as isometric exercise (IE), produces greater mean BP reductions than what has traditionally been seen with both aerobic and dynamic resistance exercise training programmes. Indeed, short duration IE training causes significant improvements in both cardiac structure and function, in addition to inducing significant reductions in resting BP in normotensive, pre-hypertensive and hypertensive individuals. This study aims to compare the acute and chronic effects of an IE training intervention on diastolic function parameters in patients who have been diagnosed with HFpEF compared to a control group.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: Isometric exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with HFpEF.
• Patients under the care of a St George's Heart Failure cardiology consultant.
• Patients willing and able to provide informed consent.
• Male and female, aged 18 years or above.
• Medically optimised patients.

Exclusion Criteria:

• Recent myocardial infarction or electrocardiographic changes, complete heart block, unstable angina.
• Inability or unwilling to provide informed consent.
• Male and female, aged 17 years or younger.
• Patients with HFrEF.
• Patients with musculoskeletal injury that could conceivably be affected by their involvement.
• Resting BP values of ≥180/110 mmHg.
• Patients unable to understand verbal and written English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Isometric exercise training	Other: Isometric exercise training; Participants randomised to the intervention will perform a 4-week programme of isometric exercise training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic function	Whether an isometric exercise training (IET) programme statistically significantly improves diastolic function parameters in patients who have been diagnosed with HFpEF. These parameters will be measured quantitatively using transthoracic echocardiography and using measures of transmitral filling velocity (early [E] and late [A] left ventricular filling velocities), the E/A ratio and tissue Doppler velocities (mitral annulus velocities in diastole [E']) and the E/E' ratio.	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Isometric exercise training has been shown to reduce systolic and diastolic blood pressure (mmHg). Our secondary outcome measure is to record any statistically significant changes in blood pressure following a programme of isometric exercise training compared to a control group.	1-year

Collaborators and Investigators

• Sponsor: St George's, University of London

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Isometric Exercise Training
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2021.0214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No