NCT02949544已完成不适用
Water Immersion and Water-based Exercise in Patients With Chronic Stable Heart Failure: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Cardiac output
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Established diagnosis of heart failure with NTpro BNP >100
排除标准
- •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
研究组 & 干预措施
water immersion
Other
patients with heart failure will be immersed to the neck for 15 minutes
干预措施: water immersion (Other)
结局指标
主要结局
Cardiac output
时间窗: 15 minutes of water immersion
次要结局
- Heart rate (beats/minute)(15 minutes of water immersion)
- Blood pressure (mmHg)(15 minutes of water immersion)
- N-terminal pro b-type natriuretic peptide (ng/L)(10 mins after 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)
- Left ventricular end diastolic diameters (mm)(15 minutes of water immersion)
- Left ventricular end systolic diameter (mm)(15 minutes of water immersion)
研究者
研究点 (2)
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