Clinical trial NCT02949544: Water Immersion in Chronic Stable Heart Failure
Official title: Water Immersion and Water-based Exercise in Patients With Chronic Stable Heart Failure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2016-10-31
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiac output
timeFrame: 15 minutes of water immersion
Secondary outcomes:
measure: Heart rate (beats/minute)
timeFrame: 15 minutes of water immersion
measure: Blood pressure (mmHg)
timeFrame: 15 minutes of water immersion
measure: systemic vascular resistance (dyn·s/cm5)
timeFrame: 15 minutes of water immersion
measure: Stroke volume (millilitres)
timeFrame: 15 minutes of water immersion
measure: Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)
timeFrame: 15 minutes of water immersion
measure: BORG dyspnoea score (score between 1-10)
timeFrame: 15 minutes of water immersion
measure: cardiac output (milliliters/minute)
timeFrame: 3 minutes of exercise in water
measure: N-terminal pro b-type natriuretic peptide (ng/L)
timeFrame: 10 mins after water immersion
measure: Left ventricular end systolic diameter (mm)
timeFrame: 15 minutes of water immersion
measure: Left ventricular end diastolic diameters (mm)
timeFrame: 15 minutes of water immersion
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
Study officials:
affiliation: Castle Hill Hospital
name: Andrew Clark
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.