Water Immersion in Chronic Stable Heart Failure

Heart Failure Clinical Trial

— IMMERSE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949544
• Other study ID #: R1996
• Status: Completed
• Phase: N/A
• Start date: November 22, 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: June 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• water immersion
warm water immersion

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital	Cottingham

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

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

External Links

•   Full PDF Original Paper