Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT07043959
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2025-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Isometrics Versus Range of Motion Exercises on Pain, Mobility and Functional Independence in Post-Mastectomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016059', 'term': 'Range of Motion, Articular'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-06-21', 'studyFirstSubmitQcDate': '2025-06-21', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Pain', 'timeFrame': 'Eight Weeks', 'description': 'Numeric Pain Rating Scale (NPRS) with decreasing values indicates improved patient condition and reduced pain intensity.'}, {'measure': 'Shoulder ROM', 'timeFrame': 'Eight Weeks', 'description': 'Goniometer with increasing ROM indicates improved patient condition and joint movements.'}], 'secondaryOutcomes': [{'measure': 'Shoulder Functional Independence', 'timeFrame': 'Eight Weeks', 'description': 'Upper Extremity Functional Scale determines the level of function of participant where higher score indicates improved upper extremity function and reduced functional impairment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Isometric Exercises', 'Range of Motion Exercises', 'Pain', 'Mobility', 'Functional Independence', 'Post-mastectomy'], 'conditions': ['Post Mastectomy', 'Postmastectomy Pain']}, 'descriptionModule': {'briefSummary': 'The aim of study was to investigate the comparative effectiveness of Isometrics versus Range of Motion (ROM) Exercises on Pain, Mobility and Functional Independence post-mastectomy. A randomized clinical trial was conducted, in which 30 participants were randomly assigned to 2 parallel groups. One group received Isometric Exercises, while the other received Range of Motion Exercises. Outcome measures included pain, range of motion and functional independence. Treatments were administered 3 times per week with 2 sets of each exercise with 5-7 repetitions per day for a duration of eight weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women between the ages of 45 and 65\n* Underwent a one-sided mastectomy\n* No history of shoulder injuries\n* Able to understand instructions and provide informed consent\n\nExclusion Criteria:\n\n* Experiencing severe pain\n* Diagnosed with advanced lymph edema\n* Physically unable to engage in exercises\n* Medically unstable'}, 'identificationModule': {'nctId': 'NCT07043959', 'briefTitle': 'Comparative Effects of Isometrics Versus Range of Motion Exercises on Pain, Mobility and Functional Independence in Post-Mastectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Faisalabad'}, 'officialTitle': 'Comparative Effects of Isometrics Versus Range of Motion Exercises on Pain, Mobility and Functional Independence in Post-Mastectomy Patients', 'orgStudyIdInfo': {'id': 'TUF/PB/40/1033/40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isometrics Exercise Group A', 'description': 'Group A received a hot pack for 10-15 minutes and performed deep breathing exercises for 3-4 repetitions. Patients were instructed in diaphragmatic breathing, where they inhaled deeply, held their breath for 2-3 seconds, and then exhaled. Following this, isometric exercises were performed, consisting of 2 sets of each exercise with 5-7 repetitions per set, done three times per week for a total duration of 8 weeks.', 'interventionNames': ['Procedure: Isometrics Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Range of Motion Exerccise Group B', 'description': 'Group B received a hot pack for 10-15 minutes and performed deep breathing exercises for 3-4 repetitions. Patients were guided in diaphragmatic breathing, where they inhaled deeply, held their breath for 2-3 seconds, and then exhaled. Afterward, they performed Range of Motion (ROM) exercises, consisting of 2 sets of each exercise with 5-7 repetitions per set, conducted three times per week over a period of 8 weeks.', 'interventionNames': ['Procedure: Range of Motion Exercises']}], 'interventions': [{'name': 'Isometrics Exercise', 'type': 'PROCEDURE', 'description': 'Shoulder Squeeze:\n\nThe therapist instructed the patient to lift their arms to shoulder height while keeping the elbows bent, then move the arms backward until the shoulder blades come together.\n\nArm Lift to Front and Side:\n\nThe therapist instructed the patient to raise their arm forward and upward while applying gentle resistance for 2-3 seconds to facilitate front arm elevation. Then, the patient was guided to lift the arm sideways, with slight resistance applied for 2-3 seconds to assist in side-arm elevation.', 'armGroupLabels': ['Isometrics Exercise Group A']}, {'name': 'Range of Motion Exercises', 'type': 'PROCEDURE', 'description': 'Wall Climb for Flexion: The therapist instructed the patient to move their fingers upward along the wall until they reach their limit, then repeat the movement.\n\nArm across Chest for Adduction and Internal Rotation: The therapist instructed the patient to move the affected arm toward the unaffected arm and shoulder.\n\nWand Exercise for Flexion and Abduction: The patient was instructed to hold a wand with both hands and move it forward and sideways toward the affected side', 'armGroupLabels': ['Range of Motion Exerccise Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Faisalābad', 'country': 'Pakistan', 'facility': 'The University of Faisalabad'}], 'overallOfficials': [{'name': 'Dr Izza Ayub; PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rehabilitaion Sciences, The University of Faisalabad'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Faisalabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Izza Ayub; PT', 'investigatorAffiliation': 'University of Faisalabad'}}}}