Role of Exercise in PRISm and Subsequent Development of COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise with telehealth group, Exercise group, No exercise group.
- Who it may be relevant to
- Registry conditions: Preserved Ratio Impaired Spirometry (PRISM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease
Overview
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.
Detailed description
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.
Interventions
- Behavioral Exercise with telehealth group
Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given. - Behavioral Exercise group
Participants will exercise with walking. Smoking cessation advice will be given. - Behavioral No exercise group
No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.
Primary outcome measures
- Change in 6 minute walk test distance [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Age below 18
- Non-smoker
- Spirometry does not show PRISm/ unable to perform spirometry
- Requires assistance for walking
- Unable to give informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The University of Hong Kong, Queen Mary Hospital — Hong Kong
Publications
- Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30. PMID 32229541
- Wan ES, Balte P, Schwartz JE, Bhatt SP, Cassano PA, Couper D, Daviglus ML, Dransfield MT, Gharib SA, Jacobs DR Jr, Kalhan R, London SJ, Navas-Acien A, O'Connor GT, Sanders JL, Smith BM, White W, Yende S, Oelsner EC. Association Between Preserved Ratio Impaired Spirometry and Clinical Outcomes in US Adults. JAMA. 2021 Dec 14;326(22):2287-2298. doi: 10.1001/jama.2021.20939. PMID 34905031
- Perez-Padilla R, Montes de Oca M, Thirion-Romero I, Wehrmeister FC, Lopez MV, Valdivia G, Jardim JR, Muino A, B Menezes AM; PLATINO Group. Trajectories of Spirometric Patterns, Obstructive and PRISm, in a Population-Based Cohort in Latin America. Int J Chron Obstruct Pulmon Dis. 2023 Jun 21;18:1277-1285. doi: 10.2147/COPD.S406208. eCollection 2023. PMID 37366430
- Holland AE, Cox NS, Houchen-Wolloff L, Rochester CL, Garvey C, ZuWallack R, Nici L, Limberg T, Lareau SC, Yawn BP, Galwicki M, Troosters T, Steiner M, Casaburi R, Clini E, Goldstein RS, Singh SJ. Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2021 May;18(5):e12-e29. doi: 10.1513/AnnalsATS.202102-146ST. PMID 33929307
Identifiers
NCT: NCT07387432 · UW 24-461