Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-04-08 @ 2:15 PM
Study NCT ID:
NCT06763718
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2024-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Fitness: Post Bariatric Surgery With Modified Qigong Breathing Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2024-12-31', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function by (SP - electronic hand held spirometer)', 'timeFrame': 'at base line and 8 weeks', 'description': 'Forced vital capacity (FVC) \\[Time Frame: 8 weeks\\]'}, {'measure': 'Core endurance by McGill tests', 'timeFrame': 'At base line and 8 weeks', 'description': 'trunk anterior flexor test'}, {'measure': 'Pulmonary function by (SP - electronic hand held spirometer)', 'timeFrame': 'at base line and 8 weeks', 'description': 'forced expiratory volume in 1 second (FEV1) \\[Time Frame: 8 weeks\\]'}, {'measure': 'Pulmonary function by (SP - electronic hand held spirometer)', 'timeFrame': 'at base line and 8 weeks', 'description': 'Peak expiratory flow (PEF) \\[Time Frame: 8 weeks\\]'}, {'measure': 'Core endurance by McGill tests', 'timeFrame': 'at base line and 8 weeks', 'description': 'trunk posterior extensor test'}, {'measure': 'Core endurance by McGill tests', 'timeFrame': 'at base line and 8 weeks', 'description': 'the right lateral plank'}], 'secondaryOutcomes': [{'measure': 'Resting metabolic rate', 'timeFrame': 'at base line and 8 weeks', 'description': 'Change in resting metabolic rate measured by indirect calorimetry at 0 and 8 weeks.'}, {'measure': 'Percent fat mass', 'timeFrame': 'at base line and 8 weeks', 'description': 'Change in fat mass percentage measured by DXA at 0 and 8 weeks'}, {'measure': 'Weight measurement', 'timeFrame': 'ate base line and 8 weeks', 'description': 'Weight measurement in kilogram'}, {'measure': 'Height measurement', 'timeFrame': 'at base line and 8 weeks', 'description': 'Height measurement in centimeter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fitness', 'Bariatric Surgery', 'Qigong Breathing Exercise'], 'conditions': ['Bariatric Surgery']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC4888907/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery. This study was conducted to explore the influence of Modified Qigong Breathing Exercise on pulmonary function, endurance and fitness on post bariatric surgery patients.\n\nQigong as ancient Chinese traditional medicine have been documented to be effective in treating obesity. Literature showing that the desire to eat and the feeling of hunger, along with prospective food consumption in patients with obesity.', 'detailedDescription': 'Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery. This study was conducted to explore the influence of Modified Qigong Breathing Exercise on pulmonary function,endurance and fitness on post bariatric surgery patients.\n\nBariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery.\n\nQigong as ancient Chinese traditional medicine have been documented to be effective in treating obesity. Literature showing that the desire to eat and the feeling of hunger, along with prospective food consumption in patients with obesity .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and fem\n* age ranged from 18-25 years old\n* at least 6 months after BS\n\nExclusion Criteria:\n\n* Patients with nerve root compression\n* spine disorders\n* spinal fracture\n* previous spinal surgery\n* pregnancy\n* lower limb injury\n* Any contraindication to the exercise therapy'}, 'identificationModule': {'nctId': 'NCT06763718', 'briefTitle': 'Optimizing Fitness: Post Bariatric Surgery With Modified Qigong Breathing Exercise', 'organization': {'class': 'OTHER', 'fullName': 'MTI University'}, 'officialTitle': 'Optimizing Fitness: Post Bariatric Surgery With Modified Qigong Breathing Exercise', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'No exercise will be given to the participants in the control group', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Qigong Breathing Exercise', 'description': 'The exercise is recommended to be performed standing, or modified standing with trunk leaning forward and bilateral upper extremities support on countertop. Initial position: Stand up with feet shoulder-width apart, hands down along your body, or put palms on the abdomen. Take a deep breath, squaring shoulders, and pull in belly at the same time. Hold breath for 3 to 4 seconds, while keeping abdomen retracted with maximally contracting abdominal muscles. Exhale, so the shoulders go back to the starting position, while chest and abdominal muscles relax. Repeat this exercise 10 times. Note. If the stomach is difficult to draw in a standing position, it is possible to perform the exercise with both hands resting on support.', 'interventionNames': ['Other: Modified Qigong Breathing Exercise']}], 'interventions': [{'name': 'Modified Qigong Breathing Exercise', 'type': 'OTHER', 'description': 'The exercise is recommended to be performed standing, or modified standing with trunk leaning forward and bilateral upper extremities support on countertop. Initial position: Stand up with feet shoulder-width apart, hands down along the body, or put palms on the abdomen. Take a deep breath, squaring shoulders, and pull in belly at the same time. Hold breath for 3 to 4 seconds, while keeping abdomen retracted with maximally contracting abdominal muscles. Exhale, so the shoulders go back to the starting position, while chest and abdominal muscles relax. Repeat this exercise 10 times. Note. If the stomach is difficult to draw in a standing position, it is possible to perform the exercise with both hands resting on support.\n\nDuration: 30 minutes, 3 days/ week for 8 weeks', 'armGroupLabels': ['Modified Qigong Breathing Exercise']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No exercise will be given to the participants in the control group', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of ohysical therapy Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MTI University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Zaytoonah University of Jordan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assi.Prof.Dr.Ahmed Mohamed Ahmed Abd elhady Elfahl', 'investigatorFullName': 'Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d', 'investigatorAffiliation': 'Al-Zaytoonah University of Jordan'}}}}