Effect of Intermittent Hypoxia Therapy on Functional Capacity in Geriatric Cardiac Patients With Functional Impairment During a Cardiac Rehabilitation Program: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in SPPB score
研究概览
简要总结
This is a randomized control pilot study to assess the effect of intermittent hypoxia therapy on functional capacity vs conventional care in old patients with functional impairment admitted to a Phase 2 in-hospital cardiac rehabilitation program.
详细描述
Because the improvement of exercise tolerance reduces mortality in elderly patients affected by cardiovascular disease, intermittent hypoxia therapy (IHT) - defined as repeated episodes of hypoxia interspersed with normoxic periods delivered by an ad hoc device - might be a valuable tool to be associated to structured cardiac rehabilitation (CR) interventions.
The present study is a pilot, monocentric, randomized (randomization ratio 1:1), parallel group study to assess the effect of IHT on functional capacity vs conventional care in old patients with functional impairment admitted to a phase 2 in-hospital cardiac rehabilitation program.
The study will enroll cardiac patients of both genders, ≥ 75 years and with a functional impairment assessed by a Short Physical Performance Battery (SPPB) score < 7.
The effect of IHT on functional capacity will be evaluated on top of the conventional multidisciplinary CR intervention, by means of SPPB score variation; variations in quality of life and cognitive status will also be evaluated as secondary goals of the study.
The total amount of IHT sessions per patient will be 10, 1 per day over 2 weeks, the duration of each single procedure will be 45 min and the Hypoxic O2 conc.% will be 14-10. The study was approved by local ethic committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to a Phase 2 in-hospital cardiac rehabilitation program because of a recent index event;
- •Provision of signed and dated informed consent form;
- •Age ≥ 75 years;
- •Basic venous blood oxygen saturation (SpO2) level > 93% measured at the fingertip;
- •SPPB score < 7;
- •New York Heart Association (NYHA) Class I-III.
排除标准
- •Inability to give informed consent (diminished understanding or comprehension);
- •Age < 75 years;
- •SPPB Score ≥ 7;
- •NYHA Class IV and/or concomitant i.v. therapy with cardiovascular active drugs;
- •Uncontrolled angina pectoris;
- •Uncontrolled arterial hypertension;
- •Uncontrolled atrial or ventricular arrhythmias;
- •Active pericarditis or myocarditis;
- •Need of continuous or intermittent O2 therapy;
- •Hb < 10 g/dl;
- •Severe concomitant non-cardiac diseases such as cancer or any other systemic disease limiting to participate in the study
- •Acute inflammatory diseases;
- •Acute non-cardiac somatic diseases, or somatic diseases with symptoms of decompensation;
- •Currently implanted left ventricular assist device;
- •Inability to accept the procedure of breathing via facial mask.
结局指标
主要结局
Changes in SPPB score
时间窗: 30 days
The Short Physical Performance Battery (SPPB) is a series of physical performance tests used in older persons to assess lower extremity function and mobility. Score total: minimum 0 (lowest performance), maximum 12 (highest performance). Three subscales (minimum 0, maximum 4 points each one): balance test, gait speed test, chair stand test.
次要结局
- Changes in EuroQoL score(30 days)
- Changes in distance at the 6-min walking test(30 days)
- Changes in peak exercise oxygen uptake (peak VO2)(30 days)
- Changes in basal blood pressure(30 days)
- Changes in geriatric depression scale(30 days)
- Changes in basal heart rate(30 days)
- Changes in minimental state evaluation(30 days)