Combination of Cardiac Coherence to Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
APACCHE (Adapted Physical Activity and Cardiac Coherence in HEmatologic patients) study investigates effects of heart rate variability biofeedback training, combined with classical adapted physical activity, on health-related quality of life in patients previously treated for hematologic malignancies. It is a prospective, randomized clinical trial from University Hospital of Reunion Island. The main objective is evaluated with QLQ-C30 survey score differences.
详细描述
Hematologic malignancies are aggressive cancers with significant long-term effects on physical and psychological health, due to the disease itself or aggressive treatments. Physical activity, with specific treatments, improves physical and psychological health in solid tumors patients. However, in hematologic malignancies, there is unsatisfactory quality of evidence that physical activity alone improves the various dimensions of quality of life.
Recent studies on heart-brain connections suggest that a high level of coherence in the heart rate variability may induce psychophysiological positive effects. Cardiac coherence is reached when the heart rhythm pattern becomes sine-wave-like at a frequency around 0.1 Hz. This status can be increased by the mean of deep and slow breathing control and/or positive emotions. By using a heart rate variability biofeedback training, previous studies have shown effects on physiological variables such as reduction of blood pressure or increase of vagal heart rate control, and also on psychological variables such as reduction of stress, anxiety, and depression.
The APACCHE protocol investigate if cardiac coherence biofeedback training, associated with an adapted physical activity program, can improve health related quality of life in adult hematologic patients.
70 patients are randomly assigned to receive either ten sessions of cardiac coherence biofeedback (CC-BF) and the adapted physical activity program (APA) or just APA. Both interventions are conducted simultaneously over 12 weeks, with 10 sessions of CC-BF (45mn) weekly and 24 sessions of APA (1h30) bi-weekly.
Data are collected at enrollment(T1), at 6 weeks (T2), at intervention ending at 12 weeks (T3) and after a 24 weeks follow-up (T4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients, previously treated and in remission for an Hematologic malignancy, in whom APA is indicated.
- •Adult patients aged 18-65 yo
- •Followed at South University Hospital of La Réunion Island
- •Previously treated for Hematologic Malignancy, and in Remission (complete or partial)
- •6 months or less since last treatment
- •Hemoglobin steady ≥ 90g/L
- •In whom APA is prescribed
- •Ability to give oral informed consent
- •French understanding
排除标准
- •With contraindication for APA
- •Under anti-arhythmic or beta-blocker drugs
- •Cardiac insufficiency (Left ventriculi Ejection Fraction less than 40%)
- •Participation in another trial
研究组 & 干预措施
Cardiac Coherence
Patients participate to Adapted physical activity sessions and to cardiac coherence sessions
干预措施: Cardiac Coherence (Procedure)
Adapted Physical Activity
Patients only participate to Adapted physical activity sessions
干预措施: Adapted Physical Activity (Procedure)
结局指标
主要结局
Health-related quality of life
时间窗: on week 12
Health-related quality is assessed by the Quality of Life Questionnaire dedicated to cancer patients and including 30 items (QLQ-C30) developed by the European Organization for Research and Treatment of Cancer (EORTC). This questionnaire is a multimodal construct, typically including physical, emotional and psychological health issues; evaluated with the QLQ-C30 survey of the European Organization for Research and Treatment of Cancer. QLQ-C30 items are coded with the same response categories as items 6 to 28, namely "Not at all", "A little", "Quite a bit" and "Very much." Score ranges from 0 to 100, with higher score indicating higher levels of quality of life.
次要结局
- Fatigue improvement(through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up)
- Anxiety and depression improvement with Hospital Anxiety and Depression Scale (HADS) survey(through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up)
- Cardiac coherence improvement(through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up)