Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 8:04 AM
Study NCT ID:
NCT03564028
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2018-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Conservation Technique in COPD Patients
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': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients will perform two stair climbing sessions (each session include 108 steps) under two different conditions on the same day with at least 30 minutes of rest between the two sessions.\n\nthe order of the two conditions will be randomly assigned'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Dyspnea at iso time and at time limit between the two sessions', 'timeFrame': 'The outcome will be measured before, at the end and every one minute during the stair climbing sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort'}], 'secondaryOutcomes': [{'measure': 'difference in time required for the patient to climb the 6 floors', 'timeFrame': 'The outcome will be collected at the end of each sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in time (seconds) will be evaluated using a stopwatch'}, {'measure': 'Difference in respiratory rate', 'timeFrame': 'Data will be continuously collected during every sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography'}, {'measure': 'Difference in inspiratory capacity', 'timeFrame': 'The outcome will be collected before and at the end of each sessions (within 2 minutes after the end). The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in inspiratory capacity (Liters) will be measured using a portable spirometer'}, {'measure': 'Difference in Cardiac Frequency', 'timeFrame': 'Data will be continuously collected during every sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in Cardiac Frequence (bpm) using a pulse oximetry'}, {'measure': 'Difference in Oxygen Saturation', 'timeFrame': 'Data will be continuously collected during every sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in Oxygen Saturation'}, {'measure': 'Difference in peripheral muscle oxygenation', 'timeFrame': 'Data will be continuously collected during every sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.'}, {'measure': 'Difference in tidal volume', 'timeFrame': 'The outcome will be collected before and at the end of each sessions (within 2 minutes after the end). The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer'}, {'measure': 'Difference in muscular fatigue', 'timeFrame': 'The outcome will be measured before, at the end and every one minute during the stair climbing sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.', 'description': 'Difference in muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'daily activity', 'stair climbing', 'rehabilitation'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '32217783', 'type': 'DERIVED', 'citation': 'Prieur G, Combret Y, Medrinal C, Arnol N, Bonnevie T, Gravier FE, Quieffin J, Lamia B, Reychler G, Borel JC. Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study. Thorax. 2020 Jun;75(6):510-512. doi: 10.1136/thoraxjnl-2019-214295. Epub 2020 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dynamic hyperinflation during an exercise increase dyspnea and can reduce exercise capacity. Stair climbing is associated with prolonged dynamic hyperinflation and severe dyspnea in COPD patients. The aim of this study is to carry out the effect of an energy conservation technique on dyspnea to facilitate stair climbing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a diagnosis of COPD\n* Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)\n* clinically stable\n\nExclusion Criteria:\n\n* exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.\n* exacerbation during the study\n* inability to climb 6 floors'}, 'identificationModule': {'nctId': 'NCT03564028', 'acronym': 'UpstAIR', 'briefTitle': 'Energy Conservation Technique in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier du Havre'}, 'officialTitle': 'Effects of Energy Conservation Technique During Stair Climbing in COPD Patients : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2018-A00566-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'energy conservation technique', 'description': 'Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).', 'interventionNames': ['Other: energy conservation technique']}, {'type': 'OTHER', 'label': 'Control session', 'description': 'Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).', 'interventionNames': ['Other: control session']}], 'interventions': [{'name': 'energy conservation technique', 'type': 'OTHER', 'description': 'During the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps.', 'armGroupLabels': ['energy conservation technique']}, {'name': 'control session', 'type': 'OTHER', 'description': 'Patients will realize one session of stair climbing at their own pace', 'armGroupLabels': ['Control session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76290', 'city': 'Le Havre', 'state': 'Normandy', 'country': 'France', 'facility': 'Groupe Hospitalier du Havre', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier du Havre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}