Role of Exercise in PRISm and Subsequent Development of COPD

Last updated: March 4, 2026
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Smoking Cessation

Diabetes Prevention

Treatment

Exercise group

Exercise with telehealth group

No exercise group

Clinical Study ID

NCT07387432
UW 24-461
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Exercise group
Phase:
Study Start date:
July 14, 2025
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong,
    China

    Active - Recruiting

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong 1819729,
    China

    Site Not Available

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