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临床试验/NCT05832814
NCT05832814招募中不适用

The Effect of Music Therapy in Pulmonary Rehabilitation of COPD Patients Aged 40-75

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
incremental shuttle walking test(ISWT) distance

研究概览

简要总结

Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. Music therapy, such as rhythm-guided endurance training, singing training, listening to melody, may be one such potential relevant and motivating rehabilitation activity. The study aims to investigate the effects of home-based PR program with a rhythm-guided endurance walking exercise and singing training on both physiological and psychological aspects. Effects will be investigated in a randomized controlled trial (RCT) with 12-week intervention period.

详细描述

Physiology and psychology of COPD

COPD is a syndrome with a progressive pulmonary obstruction leading to increasingly impaired lung function due to chronic inflammation in the respiratory passages and pulmonary tissue. Living with COPD everyday life is a struggle and often marked with reduced physical activity, again leading to progression of disease, by which a vicious circle develops. Declining physical performance is associated with ventilation restriction, insufficient oxygen diffusion, respiratory muscle and peripheral skeletal muscle dysfunction, ventricular dysfunction and so on.

On a psychological level COPD patients tend to suffer from comorbidities such as increased stress and anxiety levels e.g. due to dyspnea and dysfunction. In conclusion, COPD often leads to a severe condition that both physically and psychologically can be very difficult to manage and cope with.

COPD and rehabilitation

Pulmonary rehabilitation (PR) is multidisciplinary and comprehensive intervention that may improve the interrelated physical and psychological consequences of the disease. It is designed to optimize functional status, reduce symptoms, improve health-related quality of life, reduce anxiety and depression, reduce exacerbations and mortality. However, in spite of documented efficacy and strong recommendations, PR is largely underutilized because most programs have been carried out on an inpatient or outpatient basis, relying on high cost, adequate doctors or therapists and regular visits to hospital. Another problem is the long-term maintenance of benefits once the hospital-based PR program has been completed, since gains achieved diminish progressively if training is abandoned. For these reasons, home-based PR has been proposed as an alternative to outpatient rehabilitation.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with a clinical diagnosis of COPD and meeting the following criteria are eligible:
  • Diagnosis of GOLD II-IV and without acute exacerbation within the last 4 weeks.
  • Motivated for participating in the project (and acceptance of randomization)
  • Sufficient mobility to attend PR

排除标准

  • Certain comorbidities (e.g. unstable coronary complications)
  • Severe cognitive disabilities (e.g. dementia)
  • Inability to cope with the program because of severe hearing or visual disorder.
  • No previous singing experience or musical competence is required.

结局指标

主要结局

incremental shuttle walking test(ISWT) distance

时间窗: 12 weeks

incremental shuttle walking test distance

次要结局

  • Spirometry(12 weeks)
  • COPD assessment test(CAT)(12 weeks)
  • St. George's Respiratory Questionnaire (SGRQ)(12 weeks)
  • Short Physical Performance Battery(SPPB)(12 weeks)
  • modified British medical research council(mMRC)(12 weeks)
  • Respiratory muscle strength(12 weeks)
  • International Physical Activity Questionnaire Short Form (IPAQ-short)(12 weeks)
  • Hospital Anxiety and Depression Scale(HADS)(12 weeks)
  • Compliance(12 weeks)

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ting YANG

Principal Investigator, Clinical Professor

China-Japan Friendship Hospital

研究点 (1)

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