Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-01 @ 11:58 AM
Study NCT ID:
NCT04653350
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2020-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Multi-Modal Exercise Training in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Females participating in a clinical trial will be kept blind with respect to their allocated exercise group. The assessor doing reporting for the DEXA scan will also be kept blind about the patient group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-17', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-11-26', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Femoral Neck BMD (FN BMD)', 'timeFrame': '8 Months', 'description': 'Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan'}, {'measure': 'Lumbar Spine BMD (LS BMD)', 'timeFrame': '8 Months', 'description': 'Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan'}], 'secondaryOutcomes': [{'measure': '1 RM for Leg Extensors', 'timeFrame': '3 Months', 'description': 'Changes from the baseline, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform leg press that is to extend knee against maximum resistance once. weight will be recorded in Kgs.'}, {'measure': '1 RM for Leg Extensors', 'timeFrame': '6 Months', 'description': 'Changes from 3 Months, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform leg press that is to extend knee against maximum resistance once. weight will be recorded in Kgs.'}, {'measure': '1 RM for Trunk Extensors', 'timeFrame': '3 Months', 'description': 'Changes Baseline, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform deadlift, maximum weight lifted will be recorded in Kgs.'}, {'measure': '1 RM for Trunk Extensors', 'timeFrame': '6 Months', 'description': 'Changes from 3 Months, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform deadlift, maximum weight lifted will be recorded in Kgs.'}, {'measure': '30-second sit to stand test (Reps)', 'timeFrame': '3 Months', 'description': 'Changes from Baseline, It involves counting the number of times the participant can rise to a full standing position from the seated position on a chair without using the arms'}, {'measure': '30-second sit to stand test (Reps)', 'timeFrame': '6 Months', 'description': 'Changes from 3 Months, It involves counting the number of times the participant can rise to a full standing position from the seated position on a chair without using the arms'}, {'measure': 'Time up and Go test', 'timeFrame': '3 Months', 'description': 'Changes from Baseline, participants will be instructed to walk at usual speed for three meter and then walk back to sit down .Note time on stopwatch .The average of tests trail will be measured as the mean of TUG.'}, {'measure': 'Time up and Go test', 'timeFrame': '6 Months', 'description': 'Changes from 3 Months, participants will be instructed to walk at usual speed for three meter and then walk back to sit down .Note time on stopwatch .The average of tests trail will be measured as the mean of TUG.'}, {'measure': 'Dynamic Gait Index', 'timeFrame': '3 Months', 'description': 'Changes from Baseline, DGI was Developed to assess the likelihood of falling in older adults. Designed to test eight facets of gait. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score is 24'}, {'measure': 'Dynamic Gait Index', 'timeFrame': '6 Months', 'description': 'Changes from 3 months, DGI was Developed to assess the likelihood of falling in older adults. Designed to test eight facets of gait. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score is 24'}, {'measure': 'Falls Efficacy Scale', 'timeFrame': '3 Months', 'description': 'Changes from Baseline, On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, patient will be asked how confident are you that you do the given activities without falling. A total score of greater than 70 indicates that the person has a fear of falling.'}, {'measure': 'Falls Efficacy Scale', 'timeFrame': '6 Months', 'description': 'Changes from 3Months, On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, patient will be asked how confident are you that you do the given activities without falling. A total score of greater than 70 indicates that the person has a fear of falling.'}, {'measure': 'Berg balance scale', 'timeFrame': '3 Months', 'description': "Changes from Baseline, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait."}, {'measure': 'Berg balance scale', 'timeFrame': '6 Months', 'description': "Changes from 3Months, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait."}, {'measure': 'Functional Reach Test (FRT)', 'timeFrame': '3 Months', 'description': 'Changes from Baseline, it is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.'}, {'measure': 'Functional Reach Test (FRT)', 'timeFrame': '6 Months', 'description': 'Changes from 3 months, it is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postmenopausal Osteoporosis', 'Postmenopausal Osteopenia']}, 'referencesModule': {'references': [{'pmid': '22640372', 'type': 'BACKGROUND', 'citation': 'Gianoudis J, Bailey CA, Sanders KM, Nowson CA, Hill K, Ebeling PR, Daly RM. Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures. BMC Musculoskelet Disord. 2012 May 28;13:78. doi: 10.1186/1471-2474-13-78.'}, {'pmid': '28975661', 'type': 'BACKGROUND', 'citation': 'Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2018 Feb;33(2):211-220. doi: 10.1002/jbmr.3284. Epub 2017 Oct 4.'}, {'pmid': '30861219', 'type': 'BACKGROUND', 'citation': 'Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. No abstract available.'}, {'pmid': '26243363', 'type': 'BACKGROUND', 'citation': 'Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5.'}, {'pmid': '30612163', 'type': 'BACKGROUND', 'citation': 'Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-intensity exercise did not cause vertebral fractures and improves thoracic kyphosis in postmenopausal women with low to very low bone mass: the LIFTMOR trial. Osteoporos Int. 2019 May;30(5):957-964. doi: 10.1007/s00198-018-04829-z. Epub 2019 Jan 5.'}, {'pmid': '21113584', 'type': 'BACKGROUND', 'citation': 'Marques EA, Mota J, Machado L, Sousa F, Coelho M, Moreira P, Carvalho J. Multicomponent training program with weight-bearing exercises elicits favorable bone density, muscle strength, and balance adaptations in older women. Calcif Tissue Int. 2011 Feb;88(2):117-29. doi: 10.1007/s00223-010-9437-1. Epub 2010 Nov 27.'}, {'pmid': '36660974', 'type': 'DERIVED', 'citation': 'Riaz H, Babur MN, Farooq A. Effects of high-intensity multi-modal exercise training (HIT-MMEX) on bone mineral density and muscle performance in postmenopausal women. A Pilot randomized controlled trial. J Pak Med Assoc. 2022 Oct;72(10):1904-1908. doi: 10.47391/JPMA.5394.'}]}, 'descriptionModule': {'briefSummary': 'in Pakistan 9.9 million people are osteoporotic and 7.2 million amongst them are women. Globally after every 3 seconds there is occurrence of fragility fracture.In Pakistan females carries different risk factors based on distinct culture, environment, diet and lifestyle. So there is dire need to conduct more high quality clinical trials at National level in order to establish strong evidence in favor of low cost but highly effective exercise protocols for such a significant public health issue.', 'detailedDescription': 'In postmenopausal age, women bones get weak and easily fracture after 50years. In Pakistan every other female is silently suffering from this disease leading to bone, joint pain and disability. This project is innovatively designed first time in Pakistan to target weak bones of women with high intensity, progressive exercise training. The objectives of this study are to determine the effects of a high intensity multi-modal exercise training on bone mineral density and functional performance in postmenopausal women.\n\nAfter initial screening based on history, subjective fracture risk calculations and subjective osteoporosis screening. Females fulfilling criteria and willing to participate in exercise trial will be recruited in the study. At baseline, DEXA scan will be done for Femoral and lumbar bone density. All performance based testing for functional performance outcome measures would be done at baseline, after 3 months \\& after 6 months. Patient will be called twice a week for 8months and DEXA will be repeated after 8months of training. It is hypothesized that supervised exercise training will improve bone mineral density and functional performance in postmenopausal women with low bone mass.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal Women, at least 3 years since last mensuration.\n* Age: 45-70years\n* Body mass index (BMI) \\<30kg/m2\n* Community ambulant without walking aid\n* Good general health\n* Willing for exercise therapy\n\nExclusion Criteria:\n\n* History of fragility fracture in addition to BMD T-score of -2.5 or less\n* MMSE \\< 20\n* Taking Hormone replacement therapy or steroids from last 1 year.\n* Had participated in regular exercise for last 1 year\n* Systemic illness: hyperthyroidism, hyperparathyroidism, Diabetes Mellitus, renal failure, any malignancy, extensive radiation exposure\n* Any orthopedic injury/disorder hindering performance of exercise.'}, 'identificationModule': {'nctId': 'NCT04653350', 'acronym': 'HIT-MMEX', 'briefTitle': 'High Intensity Multi-Modal Exercise Training in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'RiphahIU Huma Riaz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIT-MMEX Group', 'description': 'In this group Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.', 'interventionNames': ['Other: High Intensity Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'In this Group Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training \\& balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.', 'interventionNames': ['Other: General Exercises']}], 'interventions': [{'name': 'High Intensity Exercises', 'type': 'OTHER', 'description': 'Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.', 'armGroupLabels': ['HIT-MMEX Group']}, {'name': 'General Exercises', 'type': 'OTHER', 'description': 'Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training \\& balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Rehab Center RCRAHS Potohar campus', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}, {'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Behbud Association of Pakistan', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Huma Riaz, Phd*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}, {'name': 'Muhammad Naveed Babur, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Isra University islamabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Huma Riaz', 'investigatorAffiliation': 'Riphah International University'}}}}