Water Immersion in Chronic Stable Heart Failure

NCT ID: NCT02949544

Last Updated: 2019-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-22

Study Completion Date

2017-04-04

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label

Study Groups

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water immersion

patients with heart failure will be immersed to the neck for 15 minutes

Group Type OTHER

water immersion

Intervention Type OTHER

warm water immersion

Interventions

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water immersion

warm water immersion

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Clark

Role: PRINCIPAL_INVESTIGATOR

Castle Hill Hospital

Locations

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Castle Hill Hospital

Cottingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 30267153 (View on PubMed)

Related Links

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Other Identifiers

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R1996

Identifier Type: -

Identifier Source: org_study_id

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