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Completed

NCT Number: NCT02949544

Water Immersion in Chronic Stable Heart Failure

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Castle Hill Hospital

Cottingham, HU165JQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water Immersion

Other

warm water immersion

Primary outcomes

  1. Cardiac output

    Time frame: 15 minutes of water immersion

Secondary outcomes

  1. Heart rate (beats/minute)

    Time frame: 15 minutes of water immersion

  2. Blood pressure (mmHg)

    Time frame: 15 minutes of water immersion

  3. systemic vascular resistance (dyn·s/cm5)

    Time frame: 15 minutes of water immersion

  4. Stroke volume (millilitres)

    Time frame: 15 minutes of water immersion

  5. Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)

    Time frame: 15 minutes of water immersion

  6. BORG dyspnoea score (score between 1-10)

    Time frame: 15 minutes of water immersion

  7. cardiac output (milliliters/minute)

    Time frame: 3 minutes of exercise in water

  8. N-terminal pro b-type natriuretic peptide (ng/L)

    Time frame: 10 mins after water immersion

  9. Left ventricular end systolic diameter (mm)

    Time frame: 15 minutes of water immersion

  10. Left ventricular end diastolic diameters (mm)

    Time frame: 15 minutes of water immersion

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: IMMERSE-HF

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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