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临床试验/NCT01235481
NCT01235481已完成3 期

Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial.

Nova Scotia Health Authority4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
90
试验地点
4
主要终点
6MWD

研究概览

简要总结

The Public Health Agency of Canada estimates that over 3.5 million Canadians live with chronic respiratory diseases, such as COPD (chronic bronchitis and emphysema), asthma, sleep apnea, and lung cancer. Nova Scotia has been reported to have one of the highest rates of chronic lung disease among Canadian provinces, likely a reflection of both the age of the population and high rates of exposures to occupational dusts and smoking. Pulmonary rehabilitation is a multidisciplinary intervention, involving exercise and education for patients with chronic lung disease. Pulmonary rehabilitation has been demonstrated to improve patient symptoms, exercise capacity, and quality of life while reducing health resource utilization. Many studies have shown that the benefits of pulmonary rehabilitation tend to diminish over time after program completion. The best interventions to maintain the benefits of pulmonary rehabilitation remain unclear.

The purpose of this study is to validate incorporation of an exercise DVD into a maintenance program after pulmonary rehabilitation. 100 subjects will be recruited over 2-years from pulmonary rehabilitation programs at Capital Health, with 50 individuals randomized to usual care following PR and 50 individuals randomized to usual care plus the exercise DVD. Study subjects will be evaluated at time of enrolment in pulmonary rehabilitation, at completion of pulmonary rehabilitation and 6-months post- pulmonary rehabilitation. Study outcome measures will include exercise capacity, exercise compliance, health-related quality of life, confidence with performing exercise, and satisfaction with the exercise DVD. The primary outcome measure will be a change in functional exercise capacity as determined by the distance walked in 6-minutes, a commonly used and validated assessment tool for patients with chronic lung disease.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any participant enrolled in pulmonary rehabilitation program

排除标准

  • Patients who do not have access to a DVD player.
  • Inability to commit to the study plan.
  • Cognitive or language barriers interfering with completion of the study procedures

结局指标

主要结局

6MWD

时间窗: 6 months

次要结局

  • disease-specific quality of life (CRQ)(6 months)
  • subject satisfaction(6 months)
  • exercise compliance(6 months)
  • exercise self-efficacy(6 months)

研究者

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

Paul Hernandez

Principle Investigator

Nova Scotia Health Authority

研究点 (4)

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