Preserved Ratio Impaired Spirometry (PRISM)NCT07387432
Role of Exercise in PRISm and Subsequent Development of COPD
A study testing Exercise with telehealth group, Exercise group and No exercise group in people with Preserved Ratio Impaired Spirometry (PRISM), run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preserved Ratio Impaired Spirometry (PRISM)
- What is being tested?
- Exercise with telehealth group, Exercise group and No exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age below 18
- Non-smoker
- Spirometry does not show PRISm/ unable to perform spirometry
- Requires assistance for walking
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong, Queen Mary Hospital
Hong Kong
King Pui Florence Chan, MD, +852 22553741, kpfchan@hku.hk
About this study
Official title: Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Being tested
- Exercise with telehealth group, Exercise group, No exercise group
- Keywords
- Preserved ratio impaired spirometry, PRISm, exercise with telehealth, walking exercise, smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with telehealth groupBehavioural
Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.
Exercise groupBehavioural
Participants will exercise with walking. Smoking cessation advice will be given.
No exercise groupBehavioural
No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.
| Study group | Role | What they receive |
|---|---|---|
| Exercise with telehealth group | Experimental | Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given. Receives: Behavioral: Exercise with telehealth group |
| Exercise group | Active comparator | Participants will exercise with walking. Smoking cessation advice will be given. Receives: Behavioral: Exercise group |
| No exercise group | Active comparator | No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given. Receives: Behavioral: No exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start14 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preserved Ratio Impaired Spirometry (PRISM)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- King Pui Florence Chan, MD, Principal investigator, he University of Hong Kong, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387432
- Sponsor's protocol ID
- UW 24-461
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the current ethics approval protocol, the IPD will be stored anonymously and destroyed 3 years after completion of study.
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.
PubMed 32229541Wan 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.
PubMed 34905031Perez-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.
PubMed 37366430Holland 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.
PubMed 33929307
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07387432
- Acronym / sponsor ID
- UW 24-461
- Keywords
- Preserved ratio impaired spirometry, PRISm, exercise with telehealth, walking exercise, smoking cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise with telehealth group | Experimental | Behavioral: Exercise with telehealth groupParticipants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given. |
| Exercise group | Active comparator | Behavioral: Exercise groupParticipants will exercise with walking. Smoking cessation advice will be given. |
| No exercise group | Active comparator | Behavioral: No exercise groupNo exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Age below 18
- Non-smoker
- Spirometry does not show PRISm/ unable to perform spirometry
- Requires assistance for walking
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with telehealth groupParticipants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given. | Behavioural | Exercise with telehealth group |
| Exercise groupParticipants will exercise with walking. Smoking cessation advice will be given. | Behavioural | Exercise group |
| No exercise groupNo exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given. | Behavioural | No exercise group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 32229541Hansen 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.
- Background: PubMed 34905031Wan 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.
- Background: PubMed 37366430Perez-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.
- Background: PubMed 33929307Holland 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.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) report. GOLD works with health care professionals and public health officials to raise awareness of Chronic Obstructive Pulmonary Disease (COPD).Link provided by the sponsor.
- Individual participant dataSharing planned: No. According to the current ethics approval protocol, the IPD will be stored anonymously and destroyed 3 years after completion of study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
King Pui Florence Chan, MD principal investigator
he University of Hong Kong, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with telehealth group, Exercise group and No exercise group in people with Preserved Ratio Impaired Spirometry (PRISM), run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact King Pui Florence Chan, MD (+852 22553741, kpfchan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 minute walk test distance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07387432, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.