Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:41 PM
Study NCT ID:
NCT07387432
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Exercise in PRISm and Subsequent Development of COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 6 minute walk test distance', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preserved ratio impaired spirometry', 'PRISm', 'exercise with telehealth', 'walking exercise', 'smoking cessation'], 'conditions': ['Preserved Ratio Impaired Spirometry (PRISM)']}, 'referencesModule': {'references': [{'pmid': '32229541', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34905031', 'type': 'BACKGROUND', 'citation': "Wan 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."}, {'pmid': '37366430', 'type': 'BACKGROUND', 'citation': 'Perez-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.'}, {'pmid': '33929307', 'type': 'BACKGROUND', 'citation': 'Holland 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.'}], 'seeAlsoLinks': [{'url': 'https://goldcopd.org/', 'label': '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).'}]}, 'descriptionModule': {'briefSummary': '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.\n\nWhile 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.', 'detailedDescription': "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.\n\nThe 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.\n\nSmoking 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or above\n* Smoker/ ex-smoker\n* Spirometry shows PRISm, with FEV1/FVC \\>= 0.7 and FEV1 \\<80% predicted\n* Ambulatory to walk\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Age below 18\n* Non-smoker\n* Spirometry does not show PRISm/ unable to perform spirometry\n* Requires assistance for walking\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT07387432', 'briefTitle': 'Role of Exercise in PRISm and Subsequent Development of COPD', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'UW 24-461'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise with telehealth group', 'description': 'Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.', 'interventionNames': ['Behavioral: Exercise with telehealth group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise group', 'description': 'Participants will exercise with walking. Smoking cessation advice will be given.', 'interventionNames': ['Behavioral: Exercise group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No exercise group', 'description': 'No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.', 'interventionNames': ['Behavioral: No exercise group']}], 'interventions': [{'name': 'Exercise with telehealth group', 'type': 'BEHAVIORAL', 'description': 'Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.', 'armGroupLabels': ['Exercise with telehealth group']}, {'name': 'Exercise group', 'type': 'BEHAVIORAL', 'description': 'Participants will exercise with walking. Smoking cessation advice will be given.', 'armGroupLabels': ['Exercise group']}, {'name': 'No exercise group', 'type': 'BEHAVIORAL', 'description': 'No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.', 'armGroupLabels': ['No exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'King Pui Florence Chan, MD', 'role': 'CONTACT', 'email': 'kpfchan@hku.hk', 'phone': '+852 22553741'}], 'facility': 'The University of Hong Kong, Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'King Pui Florence Chan, MD', 'role': 'CONTACT', 'email': 'kpfchan@hku.hk', 'phone': '+852 22553741'}], 'overallOfficials': [{'name': 'King Pui Florence Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'he University of Hong Kong, Queen Mary Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'According to the current ethics approval protocol, the IPD will be stored anonymously and destroyed 3 years after completion of study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}