Can Rehabilitation Training With Music-support Increase Exercise Tolerance in Individuals With COPD and CRF Compared to Rehabilitation Training Alone? A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- Change in effort tolerance at 6 minutes walking test: Minimal Clinical Important Difference (MCID) at 6MWT
研究概览
简要总结
Therapeutic-rehabilitative interventions supported by music can be considered important resources in many clinical contexts. Some studies report the improvement of psychological (i.e. anxiety) and physiological parameters such for example, dyspnea, blood pressure, quality of life, sleep disturbances, etc. through voice, singing, exercise with wind instruments, and sometimes listening to music. Among the various instruments proposed to support the physical training of COPD patients, music was also tested and, in particular, music as a distracting auditory stimulus (DAS) has been used to increase exercise and physical activity adherence and to reduce the perception of dyspnea in COPD subjects.
This randomized controlled trial will compare -in patients with COPD and CRF- the effects of the addiction of music to the training on exercise capacity (possible improvement of endurance and reduction of fatigue and dyspnea) with respect to the usual rehabilitation modality (no music).
详细描述
Background:
Several studies had proposed to support the physical training of COPD patients with and without chronic respiratory failure (CRF), with external systems such as oxygen therapy, high-flow oxygen therapy, and noninvasive ventilation, to improve performance during exercise training.
More recently, the role of music therapy has been also tested. Therapeutic-rehabilitative interventions supported by music can be considered important resources in many clinical contexts. The active and receptive approaches of music therapy (based respectively on sound-music interaction with the patient and introspection through musical listening techniques) are intended to improve relationships in terms of communication, expression, and regulation of emotions. Anyway, the use of sound and music is widely used in the rehabilitation context: music therapy in the neurological field, for example, consists of about 20 techniques that aim to improve neuromotor, and cognitive and sensory rehabilitation, as well. Some studies report the improvement of psychological (anxiety) and physiological parameters such as, for example, dyspnea, blood pressure, quality of life, sleep disturbances, etc. through voice, singing, exercise with wind instruments, and sometimes listening to music. OIn the studies conducted on patients with COPD, listening to music-staff during an exercise training session, have shown greater tolerance to high-intensity exercise demonstrated by a greater endurance time as well as listening to rhythmic music has allowed for greater exercise intensity. Furthermore, music as a distracting auditory stimulus (DAS) has been used to increase exercise and physical activity adherence and to reduce the perception of dyspnea in COPD subjects. A review of thirteen studies using DAS in 415 participants demonstrated that DAS increased exercise capacity when applied for at least 2 months of training (in most cases during walking), while the quality of life improved only after training of at least 3 months; the patient had less dyspnea using DAS during exercise, but this was not consistently observed in short-term exercise tests or the symptom management strategy at rest.
To date, there are no studies that evaluate whether a medium-term training cycle supported by music can further improve exercise tolerance in deconditioned subjects, such as patients with COPD and chronic respiratory failure (CRI), in comparison to subjects performing training without music.
In the present study, music will therefore be used to support training in a group of randomized patients with COPD and CRF to improve their endurance and reduce the perception of fatigue and dyspnea with respect to patients performing the usual rehabilitation training (without music). Possible improvements in performance and related physiological parameters are expected.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD (Forced expiratory volume in 1 second / post-bronchodilator forced vital capacity < 0.7) without functional reversibility
- •Chronic respiratory failure with stable hypoxia (PaO2 < 60 mmHg in room air)
- •Long Term Oxygen Therapy (LTOT) for at least 3 months
- •Clinical stability: pH range 7.38-7.42, with no recent exacerbations in the last 7 days and no changes in drug therapy in the previous 7 days
排除标准
- •Non-invasive ventilation at home
- •Cognitive impairment (Mini-Mental State Examination Score < 22)
- •Asthma or evidence of bronchodilator response
- •Pulmonary fibrosis
- •Obstructive sleep apnea syndrome
- •Lung cancer
- •Active microbial infections
- •Neuromuscular, orthopedic, and/or medical conditions that preclude testing
- •Pulmonary rehabilitation program in the previous 6 months
研究组 & 干预措施
Usual training with the support of music (MS)
This is the group performing training with the support of the music; it will be the intervention study group (MS)
干预措施: MS group (Other)
Usual training without music (C)
This is the usual training group without the support of the music, it will be the control group (C)
干预措施: C group (Other)
结局指标
主要结局
Change in effort tolerance at 6 minutes walking test: Minimal Clinical Important Difference (MCID) at 6MWT
时间窗: From the date of randomization to the End of the program (up to 3 weeks)
To evaluate whether the training exercise with music, compared to usual training (without music), is more effective in improving the exercise capacity measured in terms of the number of patients able to achieve the MCID (Minimal Clinical Important Difference) of 30 meters at the six-minute walking test (6MWT).
次要结局
- Change in dyspnea: total sessions(From the date of randomization to the End of the program (up to 3 weeks))
- Change in effort tolerance at the constant load exercise test (CLET)(From the date of randomization to the End of the program (up to 3 weeks))
- Change in dyspnea:iso-times at CLET(From the date of randomization to the End of the program (up to 3 weeks))
- Change in effort tolerance at 6 minutes walking test: distance at 6MWT(From the date of randomization to the End of the program (up to 3 weeks))
- Change in dyspnea during daily life activities (ADL) by Barthel Dyspnea Index(From the date of randomization to the End of the program (up to 3 weeks))
- Change in dyspnea during daily life activities (ADL) by Medical Research Council (MRC)(From the date of randomization to the End of the program (up to 3 weeks))
- Change in the disease impact status by COPD Assessment Test (CAT)(From the date of randomization to the End of the program (up to 3 weeks))
