Role of Exercise in PRISm and Subsequent Development of COPD

ConditionPreserved Ratio Impaired Spirometry (PRISM)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Hong Kong

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 18 or above

Smoker/ ex-smoker

Spirometry shows PRISm, with FEV1/FVC >= 0.7 and FEV1 <80% predicted

Ambulatory to walk

Disqualifiers

Age below 18

Non-smoker

Spirometry does not show PRISm/ unable to perform spirometry

Requires assistance for walking

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Exercise with telehealth groupExperimental treatment 1 intervention

Group B: Exercise groupActive comparator 1 intervention

Group C: No exercise groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in 6 minute walk test distance

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.

Time frame

1 year

Sponsors and contacts

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The University of Hong Kong

Lead sponsor

Queen Mary Hospital, Hong Kong

Collaborator

Source ClinicalTrials.gov

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