Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT06455033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual Diaphragm Release on Stepping Reaction Time in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stepping reaction time', 'timeFrame': 'up to 8 weeks', 'description': 'stepping reaction time will be assessed by choice stepping reaction time test. The test procedure is as follows: when the stepping target is illuminated in a random order, the subject steps onto the illuminated target as quickly as possible.4 The faster the reaction, the shorter the reaction time.'}, {'measure': 'Balance', 'timeFrame': 'up to 8 weeks', 'description': 'Balance Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score \\< 10 seconds = normal \\< 20 seconds = good mobility; can walk outside alone; does not require a walking aid \\< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'Finding the effect of diaphragm release exercises on stepping reaction time and balance in patients with chronic obstructive pulmonary disease patients.', 'detailedDescription': "Sixty patients with Chronic Obstructive Pulmonary Disease (COPD) will be randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be 55 years and above with history of COPD. The Ex group will attend 4 sessions/week of Manual Diaphragm Release Technique Combined with Deep Breathing (10:15-min) for 8 weeks, the CON will attend 4 sessions/week of Deep Breathing (10:15-min) for 8 weeks. The stepping reaction time will be assessed by the choice stepping reaction time (CSRT). The Balance will be determined using a Time up and Go test (TUG) an d Berg balance scale (BBS). All the outcomes will be examined at baseline, and 8 weeks of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants with a history of COPD\n* Adults ranging from 55- 70 years old of both genders.\n* Medically stable\n\nExclusion Criteria:\n\n* Obesity (BMI ≥ 30 kg/m2)\n* History of Pneumonia\n* Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.\n* History of Myocardial infarction and/or cardiothoracic surgery\n* orthopedics, or neurological that may interfere the intervention.\n* Visual impairments, vestibular disorders, and postural hypotension.\n* Dementia that interferes with the ability to follow instructions.'}, 'identificationModule': {'nctId': 'NCT06455033', 'briefTitle': 'Manual Diaphragm Release on Stepping Reaction Time in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Effect of Manual Diaphragm Release Technique on Stepping Reaction Time and Balance in Patients with Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'Manual Diaphragm Release'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group', 'description': '30 patients with chronic obstructive pulmonary disease', 'interventionNames': ['Other: Manual Diaphragm Release Technique', 'Other: Breathing Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '30 patients with chronic obstructive pulmonary disease', 'interventionNames': ['Other: Breathing Exercise']}], 'interventions': [{'name': 'Manual Diaphragm Release Technique', 'type': 'OTHER', 'description': "The participant will assume a supine position with relaxed limbs. The therapist should position themselves at the head of the participant and make manual contact with the pisiform, hypothenar region, and the last three fingers on both sides, underneath the seventh to tenth rib costal cartilages. The therapist's forearms should be aligned towards the participant's shoulders. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. During exhalation, the therapist deepens their contact towards the inner costal margin while maintaining resistance. As the respiratory cycles continues, the therapist progressively increases the depth of their contact within the costal margin.", 'armGroupLabels': ['Study Group']}, {'name': 'Breathing Exercise', 'type': 'OTHER', 'description': 'Sit up straight in a chair lengthen the distance between your navel and sternum. Keep your shoulders relax.\n\nKeep the pelvis in neutral position (Sit on your sitting bones). Place your hands at either side of your lower ribs. Breath in slowly through your nose. As you inhale feel your ribs expanding outwards and upwards. During inhalation is generated expansion of the trunk in three directions front , sides and back.\n\nBreath out from your nose. As you exhale feel your lower ribs moving inwards.', 'armGroupLabels': ['Control group', 'Study Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kz Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohammed S Saif, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National institute for Gerontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical therapy', 'investigatorFullName': 'Mohammed Youssef Elhamrawy', 'investigatorAffiliation': 'Beni-Suef University'}}}}