Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 7:04 AM
Study NCT ID:
NCT03885466
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D007738', 'term': 'Kyphosis'}, {'id': 'D016103', 'term': 'Spinal Fractures'}], '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'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Research assistants and technicians collecting data will be blinded as to whether participants are in the exercise or control group. Participants will not be blinded for Nordic walking. All methods and reporting of the trial will follow Consolidated Standards of Reporting Trials (CONSORT) guidelines.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel group randomized control trial will be used to test our hypotheses. Participants randomized to the waiting-list control group will serve as controls for the baseline and 3-month measurements. The control group will receive the same 3-month Nordic walking intervention after their control follow-up measurements are completed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional balance', 'timeFrame': '3-5 minutes', 'description': 'Assessed by timed up and go test (TUG)'}, {'measure': 'Quality of life score', 'timeFrame': '5-10 minutes', 'description': 'Assessed by 36-Item Short Form Survey (SF-36). Survey consists of 36 questions with 8 sub-scales: Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Responses range from 1-6 and are scored according to a key that values each answer from 0-100, where higher values are better outcomes. The average score of each sub-scale is recorded.'}, {'measure': 'Kyphosis angle', 'timeFrame': '2-3 minutes', 'description': 'Assessed using kyphometer'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '2-4 minutes', 'description': 'Assessed by sit-to-stand test'}, {'measure': 'Mobility', 'timeFrame': '16-20 minutes', 'description': 'Assessed by 6-minute walking test'}, {'measure': 'Bone and muscle properties and estimated bone strength of the lower leg and forearm', 'timeFrame': '20-30 minutes', 'description': 'Assessed by peripheral quantitative computed tomography (pQCT)'}, {'measure': 'Total body lean tissue mass (g)', 'timeFrame': '10-20 minutes', 'description': 'Assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Proximal femur bone mineral density (g/cm^2)', 'timeFrame': '10-20 minutes', 'description': 'Assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Kyphosis angle', 'timeFrame': '3-5 minutes', 'description': 'Assessed by flexicurve'}, {'measure': 'Physical activity exercise confidence', 'timeFrame': '2-5 minutes', 'description': 'Assessed by the Exercise self-efficacy scale. Scale consists of 10 questions with responses ranging from 1 (not confident at all) to 7 (very confident). Higher values are better outcomes. Sub-scale values are summed and total value is recorded.'}, {'measure': 'Fear of falling', 'timeFrame': '2-5 minutes', 'description': 'Assessed by the 10-item falls efficacy scale. Scale consists of 10 questions with responses ranging from 1 (not confident at all) to 10 (very confident). Higher values are better outcomes. Sub-scale values are summed and total value is recorded.'}, {'measure': 'Physical activity', 'timeFrame': '7 days', 'description': 'Recording minutes of physical activity using Actigraph wGT3X-BT accelerometer monitoring'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nordic walking', 'Osteoporosis', 'Hyperkyphosis', 'Vertebral Fracture'], 'conditions': ['Osteoporosis', 'Hyperkyphosis', 'Vertebral Fracture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://research-groupstest.usask.ca/nws/index.php', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': "Nordic walking is currently offered by a number of health care practitioners as a form of exercise therapy for older adults at risk of fracture. These include older individuals with osteoporosis, previous vertebral fracture, or hyperkyphosis. To the investigators knowledge, this practice is not evidence-based and thus potentially problematic as benefits and safety of Nordic walking for individuals with osteoporosis, fractures, or hyperkyphosis are unknown. The proposed study will answer the following principal question: Does Nordic walking improve mobility, physical function, posture, and quality of life for ambulant community dwelling individuals who have osteoporosis, a history of osteoporotic fracture, or hyperkyphosis? Participants will be randomized into either the Nordic walking intervention group, or the waiting-list control group. Participants will initially train 3 times per week for 3 months, led by peer- and/or student-instructors. The Nordic walking training will depend on the participant's skill and comfort level and will consist of walking with poles over a distance set individually for each participant. The control group will receive the same 3-month Nordic walking intervention after their control follow-up measurements are completed.", 'detailedDescription': 'The investigators will include 160 individuals who have been diagnosed with osteoporosis, have history of osteoporotic fracture or hyperkyphosis (hunched-back posture). Participants will be randomized to either a Nordic walking intervention group or a waiting-list control group (the latter group will receive same intervention after the trial is completed). The pole-walking intervention will be 12 weeks in duration, including 3 weekly Nordic walking sessions (warm up, Nordic walking with posture and leg strengthening exercises and stretches) tailored to each participants. The investigators will define osteoporosis status at baseline (via DXA scans). The investigators will compare between group changes in dynamic balance, posture, quality of life, mobility, muscle strength, size and composition (using low radiation CT scans) after 3 months of Nordic walking intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Eligibility criteria for study participants:\n\n* diagnosis of osteoporosis, past vertebral fracture or hyperkyphosis\n* ambulatory (without the use of assistive devices)\n* not currently involved in moderate-vigorous exercise training, including Nordic walking, more than once per week\n* must not be diagnosed with Parkinson's disease"}, 'identificationModule': {'nctId': 'NCT03885466', 'briefTitle': 'Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis', 'orgStudyIdInfo': {'id': '140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nordic walking', 'description': 'Nordic walking exercise intervention, 3 times per week over 12 weeks', 'interventionNames': ['Behavioral: Nordic Walking exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Waiting list controls will be offered same Nordic walking intervention after 3 month follow-up measurements'}], 'interventions': [{'name': 'Nordic Walking exercise', 'type': 'BEHAVIORAL', 'description': 'Participants will initially train 3 times per week for 3 months. Training sessions will be led by trained peer- and/or student-instructors. Nordic walking sessions (starting at 20 and progressing to 60min/session) will include a warm-up, strengthening, and dynamic balance and stretching exercises in addition to Nordic walking, as per the Saskatoon Health Region guide (Saskatoon Health Region, 2014). Training (distance and intensity) will be progressive and individually set.', 'armGroupLabels': ['Nordic walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 5B2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Saija Kontulainen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal University Hospital Foundation', 'class': 'OTHER'}, {'name': 'Saskatchewan Health Research Foundation', 'class': 'OTHER'}, {'name': 'Saskatchewan Centre for Patient-Oriented Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Saija Kontulainen', 'investigatorAffiliation': 'University of Saskatchewan'}}}}