The effects of electrical muscle stimulation in patients with chronic heart failure

Not Applicable

Completed

• Conditions: Heart failure; Circulatory System

• Registration Number: ISRCTN16749049
• Lead Sponsor: niversity Hospitals Coventry & Warwickshire NHS Trust

Brief Summary

2017 results in https://pubmed.ncbi.nlm.nih.gov/28801415/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-09-30
• Study Start: 2016-12-05
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Able to provide written informed consent
2. Aged 18 years and over
3. Stable chronic systolic heart failure (LVEF < 40%) and NYHA class III-IV symptoms
4. Being treated within the University Hospital Coventry and Warwickshire NHS Trust
5. Established on reasonable standard treatment for heart failure (left ventricular systolic dysfunction)
6. Stable (defined as no hospital admission or alterations in medical therapy in the 2 weeks prior to inclusion)
7. Limited in their ability to perform exercise by either breathlessness or fatigue as a consequence of heart failure
8. Have had documented left ventricular systolic impairment on echocardiography

Exclusion Criteria

1. Serious cardiac arrhythmias
2. Current neurological disorders or previous stroke with residual neurological deficit significant enough to limit exercise
3. Orthopaedic problems in hip or knee that prevent walking
4. Neuromuscular disease
5. Documented psychiatric problems, dementia or confusion
6. Very obese (those with mid-thigh circumference more than 50cm will not be able to wear the EMS straps)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise capacity is assessed by measuring maximal oxygen consumption (VO2peak) using spirometry and the 6 Minute walk Test (6MWT) at baseline, 8 weeks and 20 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Leg strength is measured using hand held dynamometer at baseline, 8 weeks and 20 weeks<br> 2. Cardiac function is measured by 2D echocardiography and biomarker BNP at baseline and 8 weeks<br> 3. Vascular function (arterial stiffness, and endothelial function) is measured using pules wave analysis and vascular ultrasound at baseline and 8 weeks<br> 4. Physical activity is measured using sensewear activity armband at baseline, 8 weeks and 20 weeks<br> 5. Quality of life is measured using the Minnesota Living with Heart Failure Questionnaire at baseline, 8 weeks and 20 weeks<br>