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NCT Number: NCT07387432

Role of Exercise in PRISm and Subsequent Development of COPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong, Queen Mary Hospital

Hong Kong, China

Location status: Recruiting

Location contact

King Pui Florence Chan, MD

CONTACT

[email protected]

+852 22553741

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise with telehealth group

Behavioral

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

Exercise group

Behavioral

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

No exercise group

Behavioral

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

Primary outcomes

  1. Change in 6 minute walk test distance

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

King Pui Florence Chan, MD

CONTACT

[email protected]

+852 22553741

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Queen Mary Hospital, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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