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临床试验/NCT02980575
NCT02980575已完成不适用

Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial

West Park Healthcare Centre4 个研究点 分布在 2 个国家目标入组 58 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
4
主要终点
Multidimensional dyspnea profile

研究概览

简要总结

This study is aimed at determining whether listening to music during exercise will improve health-related outcomes for individuals with chronic obstructive pulmonary disease (COPD). Half of the participants will listen to music while they exercise and half will not listen to music. The study will follow participants during their pulmonary rehabilitation program and for 6 months following completion of the program.

详细描述

People with chronic obstructive pulmonary disease (COPD) are encouraged to undertake exercise training as part of their treatment. However, they often find themselves limited by breathlessness and tiredness in their legs. These barriers limit how much a person may benefit from an exercise program and how well they may keep up with a recommended schedule of exercise at home. One way of reducing feelings of breathlessness and leg tiredness is by listening to music during exercise.

The impact of adding music to exercise versus exercise alone has not been explored in the setting of pulmonary rehabilitation. This study is aimed at determining the effect of listening to music during exercise sessions on exercise capacity, symptom severity, quality of life and motivation to exercise.

People with COPD will be randomly allocated to exercise plus music or exercise alone. A music therapist will aid with music selection for the exercise plus music group and the music will be loaded onto a portable device that participants will listen to with earbuds. All participants will complete assessments before starting a pulmonary rehabilitation program, at the end of the 8-10 week program and 6 months following completion of the program. They will complete walking tests, report symptom severity and complete a series of questionnaires asking about their quality of life, symptoms and keenness to exercise.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medical diagnosis of COPD (physician diagnosis and spirometry with FEV1/FVC ratio <70) and smoking history of greater than 10 pack years
  • Stable clinical state, with no acute exacerbations over the last 6 weeks
  • Referred to pulmonary rehabilitation program

排除标准

  • Predominant diagnosis other than COPD (asthma, bronchiectasis, interstitial lung disease)
  • Co-morbidities (orthopaedic, neurological, cardiac) which might prevent safe exercise training
  • Substantial hearing difficulties (inability to hear music adequately)
  • Regularly uses music when exercising

结局指标

主要结局

Multidimensional dyspnea profile

时间窗: Change from baseline to end of 8-week PR program or 6 months follow-up

Change in end 6-minute walk test dyspnea and fatigue levels

时间窗: Change from baseline to end of 8-week PR program or 6 month follow-up

End test dyspnea and fatigue levels from best 6MWT

次要结局

  • Change in hospital anxiety and depression scale score(Change from baseline to end of 8-week PR program or 6 month follow-up)
  • Change in chronic respiratory disease questionnaire scores(Change from baseline to end of 8-week PR program or 6 month follow-up)
  • Change in multidimensional fatigue inventory score(Change from baseline to end of 8-week PR program or 6 month follow-up)
  • Change in physical activity enjoyment scale score(Change from baseline to end of 8-week PR program or 6 month follow-up)
  • Change in StepWatch physical acitvity monitor results(Change from baseline to end of 8-week PR program or 6 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roger Goldstein

Respirologist

West Park Healthcare Centre

研究点 (4)

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