Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-28 @ 8:03 AM
Study NCT ID:
NCT03120169
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2017-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in step symmetry during 20m walking', 'timeFrame': 'measurement on day 1 and 21', 'description': 'Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis'}], 'secondaryOutcomes': [{'measure': 'Change in balance performance during semi-tandem stance', 'timeFrame': 'measurement on day 1 and 21', 'description': 'patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.'}, {'measure': 'Change in balance performance during Romberg stance', 'timeFrame': 'measurement on day 1 and 21', 'description': 'patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.'}, {'measure': 'Change in balance performance during single leg stance', 'timeFrame': 'measurement on day 1 and 21', 'description': 'patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.'}, {'measure': 'Change in muscle power during counter movement jump', 'timeFrame': 'measurement on day 1 and 21', 'description': 'patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight'}, {'measure': 'Change in 1 Minute sit to stand test', 'timeFrame': 'measurement on day 1 and 21', 'description': 'Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute'}, {'measure': 'Change in 5 Repetition sit to stand test', 'timeFrame': 'measurement on day 1 and 21', 'description': 'Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible'}, {'measure': 'Change in peak muscle strength', 'timeFrame': 'measurement on day 1 and 21', 'description': 'isometric peak torque of the knee extensor muscles are measured in 90° knee angle'}, {'measure': 'Change in 4 meter gait Speed test', 'timeFrame': 'measurement on day 1 and 21', 'description': 'patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk.'}, {'measure': 'Change in 6-minute Walk test', 'timeFrame': 'measurement on day 1 and 21', 'description': 'the best out of two 6- Minute Walk Tests will be used for analysis'}, {'measure': 'Change in Hospital anxiety and Depression scale', 'timeFrame': 'measurement on day 1 and 21', 'description': 'the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'exercise', 'training', 'cycling', 'treadmill', 'walking', 'pulmonary rehabilitation'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to investigate the effects of treadmill versus cycling endurance training on Balance, gait performance and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. Walking intensity in the treadmill group will be set at 80 percent of the average speed of the 6-minute walking test. The cycling group will exercise at an intensity of 60 percent according to an Initial incremental cycling test.\n\nPatients will perform 5 to 6 training sessions per week. The total exercise duration will be progressively increased from 10 to 30 minutes. Walking or cycling intensity will also be progressively increased if perceived exertion during exercise is rated below 3 on the modified 10-point Borg scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD Stage III or IV according to the global initiative for chronic obstructive lung disease\n* impaired exercise capacity (6 Minute walk distance of less than 70% of the reference values from Troosters et al.)\n\nExclusion Criteria:\n\n* acute, severe exacerbation of COPD\n* carbon dioxide of more than 45 mmHg at rest\n* any disabilities that prevent patient form walking or cycling\n* Patient is not able to walk 20 meters without any aid (for example rollator)'}, 'identificationModule': {'nctId': 'NCT03120169', 'briefTitle': 'Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Effects of a Three Week Treadmill Versus Cycling Endurance Training on Balance, Gait Performance and Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease - a Pilot Study', 'orgStudyIdInfo': {'id': 'treadmill vs. cycling in COPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'treadmill endurance training', 'interventionNames': ['Other: treadmill endurance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cycling endurance training', 'interventionNames': ['Other: cycling endurance training']}], 'interventions': [{'name': 'treadmill endurance training', 'type': 'OTHER', 'description': 'n = 15 patients with COPD. Walking intensity will be initially set at 80 percent of 6-minute Walking test Speed with progressive increase in Duration and intensity.', 'armGroupLabels': ['treadmill endurance training']}, {'name': 'cycling endurance training', 'type': 'OTHER', 'description': 'n=15 patients with COPD. Cycling intensity will initially be set at 60 percent of Peak work rate with progressive increase in Duration and intensity', 'armGroupLabels': ['cycling endurance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83471', 'city': 'Schönau am Königssee', 'country': 'Germany', 'facility': 'Schoen Klinik Berchtesgadener Land', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head physican (department of pneumology)', 'investigatorFullName': 'Klaus Kenn', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}