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临床试验/NCT07387432
NCT07387432招募中不适用

Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Change in 6 minute walk test distance

研究概览

简要总结

Preserved Ratio Impaired Spirometry (PRISm) describes individual with spirometry findings of forced expiratory volume (FEV1) and forced vital capacity (FVC) ratio greater than 0.7 but with the FEV1 less than 80% predicted.

While the spirometry findings of individuals with PRISm can be transited into obstructive pattern, remains at PRISm or become normal spirometry, limited evidence is on the role of exercise in the course of PRISm. This study aims to investigate the role of exercise, namely exercise with telehealth and walking exercise, together with smoking cessation advice, would alter the clinical course of PRISm.

详细描述

The is an open-labelled prospective randomised control trial on individuals with spirometry findings of PRISm. Individuals who are smoker/ ex-smoker will be screened by spirometry. Eligible individuals who fulfill the inclusion and exclusion criteria will be recruited and randomised into exercise with telehealth group, exercise group and no exercise group into 1:1:1 ratio.

The intervention period is 26 weeks and the follow up period is 52 weeks. In the intervention period, individuals will be instructed to exercise accordingly. In exercise with telehealth group, exercise with telehealth will be performed 2 times per week for 1 hour. In exercise group, individuals will be instructed to have exercise with each week's goal was the lowest of three numbers: (1) the average of the most recent 7 days of step counts + 600 steps, (2) the previous goal + 600 steps, or (3) 10,000 steps per day. In no exercise group, no exercise instruction will be given.

Smoking cessation advice and clincial assessment including hospitalisation due to any respiratory or cardiovascular causes, modified Medical Research Council Dyspnea Scale, St George's Respiratory Questionnaire will be assessed in baseline, week 4, 8, 12, 26, 52. Spirometry by Spirodoc and 6 minute walk test will be assessed at baseline, week 12, 26 and 52.

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
None

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

  • Age 18 or above
  • Smoker/ ex-smoker
  • Spirometry shows PRISm, with FEV1/FVC >= 0.7 and FEV1 <80% predicted
  • Ambulatory to walk
  • Able to give informed consent

排除标准

  • Age below 18
  • Non-smoker
  • Spirometry does not show PRISm/ unable to perform spirometry
  • Requires assistance for walking
  • Unable to give informed consent

研究组 & 干预措施

Exercise with telehealth group

Experimental

Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.

干预措施: Exercise with telehealth group (Behavioral)

Exercise group

Active Comparator

Participants will exercise with walking. Smoking cessation advice will be given.

干预措施: Exercise group (Behavioral)

No exercise group

Active Comparator

No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.

干预措施: No exercise group (Behavioral)

结局指标

主要结局

Change in 6 minute walk test distance

时间窗: 1 year

The 6 minute walk test distance will be measured in the start of the study, at 3 months, 6 months and 12 months. The differences will be compared.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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