Exercise with telehealth or walking programs for people with PRISm
Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease
This project will test whether a telehealth-guided exercise program or a step-based walking program, together with smoking-cessation advice, helps people with PRISm stay stable or avoid developing COPD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07387432 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized controlled trial enrolls smokers and ex-smokers with PRISm and randomizes them 1:1:1 to telehealth-guided exercise, a progressive walking step-goal program, or no exercise instruction. The active interventions last 26 weeks (telehealth sessions twice weekly; walking program with weekly step targets) with clinical follow-up through 52 weeks. All participants receive smoking cessation advice and serial assessments including spirometry, 6-minute walk test, symptom scores, and hospitalisation tracking at scheduled visits. The trial measures whether these exercise approaches change spirometric status, functional capacity, respiratory symptoms, and healthcare events over one year.
Who should consider this trial
Good fit: Adults (≥18) who currently smoke or formerly smoked, are ambulatory, can give informed consent, and have spirometry showing PRISm (FEV1/FVC ≥ 0.7 and FEV1 < 80% predicted).
Not a fit: Non-smokers, people who cannot walk independently, those whose spirometry does not meet PRISm criteria, or those unable to attend required in-person assessments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, these interventions could slow or prevent progression from PRISm to COPD and improve breathing, exercise capacity, and quality of life.
How similar studies have performed: Exercise and pulmonary rehabilitation have improved symptoms and function in COPD and telehealth delivery has shown promise, but randomized trials specifically targeting PRISm are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- The University of Hong Kong, Queen Mary Hospital — Hong Kong, China (Recruiting)
Study contacts
- Principal investigator: King Pui Florence Chan, MD — he University of Hong Kong, Queen Mary Hospital
- Study coordinator: King Pui Florence Chan, MD
- Email: kpfchan@hku.hk
- Phone: +852 22553741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.