Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT04284605
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2020-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects Exercise Training in Patients With Pituitary Adenoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical Factors', 'timeFrame': '6 weeks', 'description': 'Concentrations of IL6, IL1beta, TNFalfa in serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pituitary Adenoma']}, 'descriptionModule': {'briefSummary': 'This study planned to investigate the effects of aerobic training combined with strengthening training and yoga on biochemical factors, physical performance and quality of life in people with pituitary adenoma. The hypotheses are; H1: Aerobic training combined with strengthening training is effective on biochemical factors in people with pituitary adenoma.\n\nH2: Aerobic training combined with strengthening training is effective on physical performance in people with pituitary adenoma.\n\nH3: Aerobic training combined with strengthening training is effective on quality of life in people with pituitary adenoma.\n\nH4: Yoga is effective on biochemical factors in people with pituitary adenoma. H5: Yoga is effective on physical performance in people with pituitary adenoma. H6: Yoga is effective on quality of life in people with pituitary adenoma. H7: Aerobic training combined with strengthening training and yoga is effective on biochemical factors, physical performance and quality of life in people with pituitary adenoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* volunteers\n* macroadenomas\n* at least 1 hormonal axis affected\n* Karnofsky Perfomance Scale between 70-100\n* 18-65 years\n* approved by cardiologists\n\nExclusion Criteria:\n\n* regular exercise habit\n* acute pain in many part of the body\n* additional neurologic condititons\n* any rheumatological and immunologic conditions'}, 'identificationModule': {'nctId': 'NCT04284605', 'briefTitle': 'Effects Exercise Training in Patients With Pituitary Adenoma', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effects of Aerobic Training Combined With Strength Training and Yoga on Biochemical Factors, Physical Performance and Quality of Life in Patients With Pituitary Adenoma', 'orgStudyIdInfo': {'id': 'KA-180156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1', 'interventionNames': ['Other: Aerobic exercise combined with strength training', 'Other: Yoga']}, {'type': 'EXPERIMENTAL', 'label': 'Group2', 'interventionNames': ['Other: Aerobic exercise combined with strength training', 'Other: Yoga']}], 'interventions': [{'name': 'Aerobic exercise combined with strength training', 'type': 'OTHER', 'description': '30 minute aerobic exercise training with warm-up and cool down followed by 30 minute strength training for specific muscles.', 'armGroupLabels': ['Group1', 'Group2']}, {'name': 'Yoga', 'type': 'OTHER', 'description': '60 minute yoga intervention including different asanas, breath control and meditation', 'armGroupLabels': ['Group1', 'Group2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06530', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no IPD will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Esra Dülger', 'investigatorAffiliation': 'Hacettepe University'}}}}