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

NCT ID: NCT05551663

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-12-31

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Isometric exercise training

Group Type: EXPERIMENTAL

Isometric exercise training

Intervention Type: OTHER

Participants randomised to the intervention will perform a 4-week programme of isometric exercise training.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Isometric exercise training

Participants randomised to the intervention will perform a 4-week programme of isometric exercise training.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2021.0214

Identifier Type: -

Identifier Source: org_study_id