Water Immersion in Chronic Stable Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT02949544
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary

This study aims to investigate the effects of water immersion and exercise on heart function and blood flow in patients with chronic stable heart failure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Study Start: 2016-11-22
• Primary Completion: 2017-04-04
• Study Completion: 2017-04-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Age >18
• Established diagnosis of heart failure with NTpro BNP >100

Exclusion Criteria

• Uncontrolled or severe heart failure, defined by NYHA class IV symptoms (breathlessness at rest)
• Severe fluid overload characterised as more than minimal pitting oedema of the ankles only
• Presence of haemodynamically significant valvular heart disease in the opinion of the investigator
• Haemoglobin <125 g/L
• Weight >120 kilograms
• Requiring long term oxygen supplementation in the community
• Hospitalisation for any cause within the last 6 weeks, that in the opinion of the investigator would affect the patients wellbeing in this study
• Unstable or severe stable angina that requires three or more antianginals
• Patients known to have disease causing immunocompromise such as HIV infection or undergoing chemotherapy
• Patients with active infection
• Dialysis patients
• Uncontrolled seizures; patients in whom the pool environment may trigger seizures, new diagnosis of epilepsy
• Insulin treated diabetic patients with hypoglycaemic episodes in the last 3 months.
• Pregnant women
• Central venous lines which are not tunnelled and are exposed superficially.
• Open access ports to lungs including tracheotomy sites
• Ventilation tubes for ears
• Nasogastric or gastrostomy tube in situ
• Presence of colostomy, ileostomy or urostomy.
• Presence of open, macerated, infected or non-intact skin or oedema with leakage of serous fluid.
• Skin condition such as severe eczema or psoriasis
• Any surgery or invasive devices fitted within the last 4 weeks
• Any form of mobility impairment requiring mobility aids (e.g. stick or wheelchair) or rendering patient unable to perform gentle exercises, including recent injury or trauma
• History of chlorine sensitivity
• Urinary or faecal incontinence
• Hydrophobia
• Unable to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cardiac output	15 minutes of water immersion

Secondary Outcome Measures

Name	Time	Method
Heart rate (beats/minute)	15 minutes of water immersion
Blood pressure (mmHg)	15 minutes of water immersion
N-terminal pro b-type natriuretic peptide (ng/L)	10 mins after water immersion
systemic vascular resistance (dyn·s/cm5)	15 minutes of water immersion
Stroke volume (millilitres)	15 minutes of water immersion
Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)	15 minutes of water immersion
BORG dyspnoea score (score between 1-10)	15 minutes of water immersion
cardiac output (milliliters/minute)	3 minutes of exercise in water
Left ventricular end systolic diameter (mm)	15 minutes of water immersion
Left ventricular end diastolic diameters (mm)	15 minutes of water immersion

Trial Locations

Locations (1)

Castle Hill Hospital; 🇬🇧 Cottingham, United Kingdom