Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT03584620
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2018-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of IMT on Physical Activity and Quality of Life in LTx Candidates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants who meet the study inclusion criteria and complete the baseline assessments were randomly allocated into one of the two groups: namely Pulmonary Rehabilitation plus Inspiratory Muscle Training Group (IMT+PR) or Pulmonary Rehabilitation Group (PR).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2018-06-30', 'studyFirstSubmitQcDate': '2018-06-30', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline International physical activity questionary short form (IPAQ-SF) score at 3-months', 'timeFrame': 'Three months', 'description': 'including seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week.'}, {'measure': 'Change from baseline Saint George Respiratory Questionaire score at 3-months', 'timeFrame': 'Three months', 'description': 'The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline distance covered in six minute walking test at 3-months', 'timeFrame': 'Three months', 'description': 'The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk. Before and after the test, oxygen saturation, heart rate, Borg fatigue rating, and walking distance were recorded.'}, {'measure': 'Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months', 'timeFrame': 'Three months', 'description': 'The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung transplantation', 'inspiratory muscle training', 'pulmonary rehabilitation', 'quality of life', 'physical activity'], 'conditions': ['Lung Transplantation', 'Inspiratory Muscle Training']}, 'descriptionModule': {'briefSummary': 'Inspiratory Muscle Training (IMT), which is used to strengthen the respiratory muscles, is one of the techniques used in PR. It is mostly used in patients with chronic obstructive pulmonary disease, and has been shown to be beneficial for functionality and also for relieving dyspnea perception. It is reported in the guidelines that IMT has additional benefit for endurance in COPD patients. However, there are no studies related to its use and effectiveness in lung transplantation. In this study, investigators hoped to increase these known benefits by adding IMT to the standard Pulmonary Rehabilitation.\n\nThere are two main objectives of this study:\n\n* to examine the effect of inspiratory muscle training on physical activity status and quality of life in lung transplantation candidates,\n* to compare physical activity and quality of life changes between the IMT+PR group and the PR group', 'detailedDescription': 'The patients in the lung transplantation waiting list were included the study. These patients were with severe lung disease requiring transplantation, and that the intervention was undertaken before any lung transplantation. The patients were eligible for inclusion if participitants have: a diagnosis of terminally severe lung disease, being listed for lung transplantation, medically stable, had no orthopedic or cardiac problems that would prevent them from exercising and had no transfer problem to the PR centre.\n\nParticipants who meet the study inclusion criteria and complete the baseline assessments were randomly allocated into one of the two groups: namely Pulmonary Rehabilitation plus Inspiratory Muscle Training Group (IMT+PR) or Pulmonary Rehabilitation Group (PR) using a numbered series of 34 prefilled envelops specifying group assignment generated by a computer-based program.\n\nAll patients underwent supervised PR program on 2 days per week for 3 months. Apart from that, participitant were asked to perform the home exercise program which was scheduled as 3 days per week and fill out the exercise follow-up form. The study group was provided with IMT in addition to the standard program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a diagnosis of terminally severe lung disease,\n* being listed for lung transplantation,\n* medically stable,\n* had no orthopedic or cardiac problems that would prevent them from exercising\n* had no transfer problem to the PR centre.\n\nExclusion Criteria:\n\n* Malignancy in the last 2 years,\n* Other advanced major organ / system dysfunction that can not be treated outside the lung,\n* Untreated non-pulmonary infection,\n* Disputed medical treatment discontinuity,\n* Untreatable psychiatric illness or psychosocial condition that interferes with treatment compliance,\n* No appropriate, reliable social support,'}, 'identificationModule': {'nctId': 'NCT03584620', 'briefTitle': 'The Effects of IMT on Physical Activity and Quality of Life in LTx Candidates', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effects of Inspiratory Muscle Training on Physical Activity and Quality of Life in Lung Transplantation Candidates', 'orgStudyIdInfo': {'id': 'IMT_LTx_PA_QOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMT+PR Group', 'description': 'Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. In addition standard pulmonary rehabilitation, patients received inspiratory muscle training.', 'interventionNames': ['Other: Inspiratory muscle training', 'Other: Pulmonary rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'PR group', 'description': 'Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training.', 'interventionNames': ['Other: Pulmonary rehabilitation']}], 'interventions': [{'name': 'Inspiratory muscle training', 'type': 'OTHER', 'description': 'Inspiratory Muscle Training was performed with an exercise tool (Powerbreath®) with a resistance range of 0-90. The training intensity was started with 30% of the Maximum Inspiratory Pressure (MIP) value obtained as a result of the mouth pressure measurement, training was progressively increased from 30% to 60% considering that they were terminal-stage pulmonary disease patients. Patients were asked to perform IMT for 15 minutes, twice a day, 7 days a week, for 3 months.', 'armGroupLabels': ['IMT+PR Group']}, {'name': 'Pulmonary rehabilitation', 'type': 'OTHER', 'description': 'Aerobic training:The aerobic exercise program consists of treadmill walking, cycle ergometer and arm ergometer training. Group exercises were performed in sets of 15 minutes each with three exercise modalities.\n\nStrength training:It is recommended that resistance targets are set at loads equivalent to 20 to 40% of a 1-repetition maximum (1RM) maneuver and performed between 8 to 12 repetitions for 1 to 2 sets per session.\n\nHome exercise programme:The program included breathing exercises (local expansion exercises, diaphragmatic breathing and pursed lip breathing), free walking, upper and lower extremity strengthening exercises with Thera-Band', 'armGroupLabels': ['IMT+PR Group', 'PR group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'esra pehlivan', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}