Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT02757157
Status:
TERMINATED
Last Update Posted:
2021-08-25
First Post:
2016-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Hydrotherapy pool has closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dyspnoea, measured by the modified Borg 0-10 category ratio scale', 'timeFrame': 'Day of assessment during study measurement period (15 minutes)'}, {'measure': 'Exertion, measured by the modified Borg 0-10 category ratio scale', 'timeFrame': 'Day of assessment during study measurement period (15 minutes)'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Day of assessment during study measurement period (15 minutes)'}, {'measure': 'Heart rate', 'timeFrame': 'Day of assessment during study measurement period (15 minutes)'}], 'primaryOutcomes': [{'measure': 'Breath-by-breath oxygen consumption (VO2)', 'timeFrame': 'Day of assessment during study measurement period (15 minutes)'}], 'secondaryOutcomes': [{'measure': 'Minute ventilation (VE)', 'timeFrame': 'Day of assessment during study measurement period (15 minutes)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hydrotherapy', 'Walking'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with peak exercise metabolic response.\n\nThe hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of COPD (FEV1/FVC \\<0.7) in a clinically stable state (no acute exacerbation of COPD within the previous 4 weeks)\n* accepting of walking in water\n* BMI \\>/= 21 kg/m2\n\nExclusion Criteria:\n\n* long-term oxygen therapy\n* contraindications to entering a hydrotherapy pool'}, 'identificationModule': {'nctId': 'NCT02757157', 'briefTitle': 'Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'European Respiratory Society'}, 'officialTitle': 'Determining the Metabolic Load of Walking in Water Compared to Walking on Land in People With COPD, Who Are Normal Weight and Obese, Compared to Peak Exercise Metabolic Response: a Prospective, Randomised Cross-over Pilot Trial', 'orgStudyIdInfo': {'id': 'ERS STRTF 2015 - 9368'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPD (normal weight)', 'description': 'People with COPD (BMI 21 kg/m2 to 29 kg/m2)', 'interventionNames': ['Behavioral: Water-based walking', 'Behavioral: Land-based walking']}, {'type': 'EXPERIMENTAL', 'label': 'COPD (obese)', 'description': 'People with COPD (BMI \\>/= 30 kg/m2)', 'interventionNames': ['Behavioral: Water-based walking', 'Behavioral: Land-based walking']}], 'interventions': [{'name': 'Water-based walking', 'type': 'BEHAVIORAL', 'description': 'Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed.\n\nDuring walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured.', 'armGroupLabels': ['COPD (normal weight)', 'COPD (obese)']}, {'name': 'Land-based walking', 'type': 'BEHAVIORAL', 'description': 'Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed.\n\nDuring walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured.', 'armGroupLabels': ['COPD (normal weight)', 'COPD (obese)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Horn', 'country': 'Netherlands', 'facility': 'Centre of intergrated rehabilitation for chronic organ failure', 'geoPoint': {'lat': 51.21, 'lon': 5.94583}}], 'overallOfficials': [{'name': 'Martijn A Spruit, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre of integrated rehabilitation for chronic organ failure'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Respiratory Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Integrated Rehabilitation and Organ Failure Horn', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Specialist Physiotherapist', 'investigatorFullName': 'Renae McNamara', 'investigatorAffiliation': 'European Respiratory Society'}}}}