Water Immersion in Chronic Stable Heart Failure (IMMERSE-HF)

Water Immersion and Water-based Exercise in Patients With Chronic Stable Heart Failure: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: water immersion

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cottingham, United Kingdom, HU165JQ
    • Castle Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: water immersion; patients with heart failure will be immersed to the neck for 15 minutes	Other: water immersion; warm water immersion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiac output	15 minutes of water immersion

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate (beats/minute)	15 minutes of water immersion
Blood pressure (mmHg)	15 minutes of 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
N-terminal pro b-type natriuretic peptide (ng/L)	10 mins after water immersion
Left ventricular end systolic diameter (mm)	15 minutes of water immersion
Left ventricular end diastolic diameters (mm)	15 minutes of water immersion

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Andrew Clark, Castle Hill Hospital

Publications and helpful links

General Publications

• Shah P, Pellicori P, Kallvikbacka-Bennett A, Zhang J, Pan D, Clark AL. Warm water immersion in patients with chronic heart failure: a pilot study : Shah immerse: HF. Clin Res Cardiol. 2019 May;108(5):468-476. doi: 10.1007/s00392-018-1376-2. Epub 2018 Sep 28.

Helpful Links

• Full PDF Original Paper

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2016
• Primary Completion (ACTUAL): April 4, 2017
• Study Completion (ACTUAL): April 4, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (ESTIMATE): October 31, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: R1996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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