Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT04898218
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2021-05-21', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Velocity', 'timeFrame': 'Baseline', 'description': 'Temporal Spatial Gait Parameter'}, {'measure': 'Gait Velocity', 'timeFrame': '12 weeks', 'description': 'Temporal Spatial Gait Parameter'}, {'measure': 'Cadence', 'timeFrame': 'Baseline', 'description': 'Temporal Spatial Gait Parameter'}, {'measure': 'Cadence', 'timeFrame': '12 weeks', 'description': 'Temporal Spatial Gait Parameter'}, {'measure': 'Gait Stability Ratio', 'timeFrame': 'Baseline', 'description': 'Temporal Spatial Gait Parameter'}, {'measure': 'Gait Stability Ratio', 'timeFrame': '12 weeks', 'description': 'Temporal Spatial Gait Parameter'}, {'measure': 'Balance', 'timeFrame': 'Baseline', 'description': 'Balance was measured through Timed-up and Go Test'}, {'measure': 'Balance', 'timeFrame': '12 weeks', 'description': 'Balance was measured through Timed-up and Go Test'}, {'measure': 'Fear of Fall', 'timeFrame': 'Baseline', 'description': 'Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.'}, {'measure': 'Fear of Fall', 'timeFrame': '12 weeks', 'description': 'Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.'}], 'secondaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': 'Baseline', 'description': 'Measured through Peripheral DXA Scan on right side calcaneal bone'}, {'measure': 'Bone Mineral Density', 'timeFrame': '12 weeks', 'description': 'Measured through Peripheral DXA Scan on right side calcaneal bone'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Bone Mineral Density', 'Postmenopausal'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'With the increase in life expectancy women spend more than one-third of their life time in post-menopausal state leading to osteoporosis in later stages. Therefore a decrease in temporal-spatial parameters of gait, high risk of fracture, imbalance in functional parameters, fear of fall and compromised health-related quality of life is observed among osteoporotic females. Several physical activities and balance training programs have been implemented globally but nationally no program has yet been designed catering gait balance and fear of fall altogether as a combined program. Therefore, the aim of this study was to determine the effectiveness of Osteoanabolic exercises on Temporal-Spatial gait parameters, Gait Stability Ratio (GSR) and Bone Mineral Density (BMD) among the osteoporotic females. Moreover, the effectiveness of these exercises was evaluated on dynamic balance using Timed Up and Go Test (TUG).\n\nFurthermore, the impact on fear of fall was identified using Fall Efficacy ScaleInternational (FES-I).', 'detailedDescription': "A 3-arm Randomized Controlled Trial was conducted at the Department of Rehabilitation Sciences, Ziauddin Hospital using the envelope method. The participants were screened on the Physical Activity Readiness and You Questionnaire (PARQ \\&YOU). Ninety-three osteoporotic females were randomly allocated into three groups; where; participant in group A' received aerobic training protocol, a participant in group B' resistance training and participant in group C' Osteoanabolic training. A Frequency Intensity Time Type (FITT) protocol according to the American College of Sports Medicine for aerobic and resistance training was incorporated whereas for Osteoanabolic group combination training protocol was used. Twelve weeks of training was conducted where pre and post readings were calculated using activPAL, TUG, FES-I and Peripheral DXA Scan."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Postmenopausal osteoporotic females screened through PARQ and YOU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal osteoporotic females aged in between 50-75 years\n* Not participating in any exercise program for the past 3 months\n* Independently ambulatory were included in the study\n\nExclusion Criteria:\n\n• Red flags that limit the recruitment of participants in an exercise program, for example, vertebral fracture, an unstable heart condition, malignancy'}, 'identificationModule': {'nctId': 'NCT04898218', 'briefTitle': 'Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females', 'orgStudyIdInfo': {'id': 'Amna Khan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Aerobic Exercise Group)', 'description': 'Warm-up exercises were performed by the participants on a cycle ergometer for a duration of 5-10 minutes. Group A was advised to start walking at a comfortable speed on a treadmill for the duration of 30-60 minutes; the intensity of the exercises was 55-75% of MHR, calculated by using a Karvonen method. Initially with the minimum intensity that was gradually raised up to the intensity of Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase for 5-10 min.', 'interventionNames': ['Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Resistance Exercise Group)', 'description': 'Group B was instructed for strengthening exercises of ten major muscle groups that include Biceps, Triceps, Pectoralis Major, Deltoid, Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight-bearing exercises was calculated using 1 Repetition Maximum (RM) method.', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (Osteoanabolic Exercise Group)', 'description': 'Group C was performed Osteoanabolic exercise divided into two different phases:\n\nAerobic Conditioning Phase Participants were instructed to walk on treadmill for 30-60 min. The intensity of the exercises was 55-75% MHR, calculated by Karvonen method. Intensity gradually raised up to the Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase. The participants performed 3 days per week for 12 weeks on alternative days.\n\nAnaerobic (Resistance) Conditioning Phase Resistance training was started on every alternative day of the aerobic conditioning (3 days per week) for 45 min. The intensity of the weight-bearing exercises was calculated using 1 RM method. Resistance training muscle and protocol was the same as for Group B. The participants performed warm-up and cool down similar to that of group A and group B.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'The exercises were performed for 12 weeks, for the maximum of 6 days/week for Osteoanabolic group, 5 days/week for aerobic group and 3 days/ week for a resistance group as per ACSM, FITT protocol.', 'armGroupLabels': ['Group A (Aerobic Exercise Group)', 'Group B (Resistance Exercise Group)', 'Group C (Osteoanabolic Exercise Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74700', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Ziauddin University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Amna Khan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistant Professor', 'investigatorFullName': 'Dr. Amna Khan', 'investigatorAffiliation': 'Ziauddin University'}}}}