Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT02218918
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2014-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Supervised Ground Walk Training and Treadmill Walk Training 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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treadmill training vs ground walk training'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Capacity (6 MINUTE WALK TEST)', 'timeFrame': 'Baseline, 6 weeks', 'description': '6 minute walk test according to standardisation of ATS'}, {'measure': 'Quality of Life (Chronic Respiratory Questionnaire)', 'timeFrame': 'Baseline, 6 weeks', 'description': 'CRQ - interviewer based'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ground walk', 'treadmill walk', 'Functional walk capacity', 'COPD', 'Quality of Life'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. The investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in COPD patients.', 'detailedDescription': 'Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is a promising management in COPD management. Exercise training in form of aerobic (walking, cycling) and strength training is an important part of pulmonary rehabilitation. However access to traditional supervised exercise programs is questionable debate even in developed western countries. Unsupervised ground walk programs are often told by physicians but not properly prescribed.\n\nObjective: To assess whether ground or treadmill walk is better in improving functional capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure: Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The intensity and progression of walk is based on 6 minute walk test. Quality of life will be gauged through Chronic respiratory questionnaire and functional capacity through 6 minute walk test.\n\nStatistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov and Variables will be compared through paired and unpaired student t tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable COPD\n* Stage II - IV\n* Both genders\n\nExclusion Criteria:\n\n* Cardiovascular diseases uncompensated\n* uncompensated pleural diseases\n* uncompensated liver diseases\n* Recent surgeries less than 3 weeks\n* malignancy receiving chemo and radiotherapy\n* Recent exacerbations less than 3 months'}, 'identificationModule': {'nctId': 'NCT02218918', 'acronym': 'GWT/TWT', 'briefTitle': 'Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'PSG Hospitals'}, 'officialTitle': 'Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients', 'orgStudyIdInfo': {'id': 'PSG01Rehab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supervised Treadmill Walk Training', 'description': 'Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks', 'interventionNames': ['Behavioral: Supervised Treadmill Walk training']}, {'type': 'EXPERIMENTAL', 'label': 'Supervised Ground walk training', 'description': 'Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks', 'interventionNames': ['Behavioral: Ground walk training']}], 'interventions': [{'name': 'Ground walk training', 'type': 'BEHAVIORAL', 'description': '3 times a week and 6 weeks', 'armGroupLabels': ['Supervised Ground walk training']}, {'name': 'Supervised Treadmill Walk training', 'type': 'BEHAVIORAL', 'description': '3 times a week and 6 weeks', 'armGroupLabels': ['Supervised Treadmill Walk Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641004', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'PSG Hospitals', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}], 'overallOfficials': [{'name': 'Baskaran Chandrasekaran, MPTh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Physiotherapist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PSG Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physiotherapist', 'investigatorFullName': 'Baskaran Chandrasekaran', 'investigatorAffiliation': 'PSG Hospitals'}}}}