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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Other: Isometric exercise training

• Registration Number: NCT05551663
• Lead Sponsor: St George's, University of London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Study Start: 2022-11
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isometric exercise training	Isometric exercise training	-

Primary Outcome Measures

Name	Time	Method
Diastolic function	1-year	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	1-year	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.