Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-01 @ 9:22 PM
Study NCT ID:
NCT04168658
Status:
UNKNOWN
Last Update Posted:
2019-11-19
First Post:
2019-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-16', 'studyFirstSubmitDate': '2019-11-16', 'studyFirstSubmitQcDate': '2019-11-16', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of habitual physical activity', 'timeFrame': 'Baseline to 12 months post-baseline', 'description': 'The primary outcome is the change of habitual physical activity from baseline to 12 months, which will be measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF).'}], 'secondaryOutcomes': [{'measure': 'Incidental falls', 'timeFrame': '12 months starting from the baseline', 'description': 'A fall is defined as "an event which results in a person coming to rest in advertently on the ground or floor or other lower level".'}, {'measure': 'Change in bone mineral density (BMD)', 'timeFrame': 'Baseline to 12 months post-baseline', 'description': 'BMD (g/cm2) of lumbar spine (L1-L4) and proximal femoral neck'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Chinese women', 'nursing home', 'physical activity', 'RCT'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Worldwide, osteoporosis causes more than 8.9 million fractures per annum. Osteoporosis used to be a significant public health concern that most commonly affected Caucasian women in Northern Europe and the United States. Recently, it has become a major public health problem in Asia, most notably among Chinese women.\n\nWe intend to conduct a cluster randomized controlled trial (RCT) to examine if a physical activity and education intervention, compared with an education-only intervention (waiting list for physical activity), can result in improved physical activity, reduced falls, and maintaining bone mass, among female nursing home residents in China. The aim of the current pilot and feasibility trial is to test the feasibility and acceptability of conducting these interventions.\n\nA pilot and feasibility cluster RCT will be conducted for females aged 60 to 75 years living in nursing homes in Chengdu, the capital of Sichuan Province, Western China. The unit of cluster randomization is the nursing home. A total of four nursing homes (two state-owned and two private-owned) will be involved in the pilot and feasibility trial. They will be randomly selected and afterwards randomly assigned to either the intervention group (2 nursing homes) or control group (2 nursing homes). We seek to recruit 20 women from each nursing home.\n\nThe intervention group participants will exercise with the research staff or under supervision of the trained nursing home staff, and will receive face-to-face workshops, booklet, newsletters, phone calls, and short message service (SMS) reminders. Participants in the control group will only receive educational materials (i.e. face-to-face workshops and booklet) and will be wait listed to receive no other interventions of this study until after the post-intervention. All participants will be referred to doctors for advice and standard care as usual.\n\nThe primary outcome is the change of habitual physical activity from baseline to 12 months, which will be measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Secondary outcomes include incidental falls and change in bone mineral density (BMD) from baseline to 12 months. The study results will serve to provide an estimate of the effect size, intraclass correlation coefficient (ICC) and rates of eligibility, recruitment and attrition, which may enable a more accurate sample size calculation for a definitive RCT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (cluster level-nursing home):\n\n* have at least 100 female residents aged 60 to 75 years\n\nExclusion Criteria (cluster level-nursing home):\n\n* are participating in any other clinical trials\n\nInclusion Criteria (participant level):\n\n* female\n* aged 60 to 75 years\n\nExclusion Criteria (participant level):\n\n* have a previous diagnosis of osteoporosis\n* are osteoporotic\n* are taking medicines that would affect calcium or bone metabolism\n* are already physically active (i.e. exercise at least three times a week at a moderate or higher intensity for ≥ 30 min)\n* have taken part in any physical activity program within the past year\n* sustain any medical condition that would put them at risk by taking part in moderate intensity exercises'}, 'identificationModule': {'nctId': 'NCT04168658', 'briefTitle': 'A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu Jinjiang Maternity and Child Health Hospital'}, 'officialTitle': 'A Pilot and Feasibility Cluster Randomized Controlled Trial of Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis', 'orgStudyIdInfo': {'id': '201909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity and education intervention', 'interventionNames': ['Combination Product: Physical activity and education intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education intervention', 'interventionNames': ['Behavioral: Education intervention']}], 'interventions': [{'name': 'Physical activity and education intervention', 'type': 'COMBINATION_PRODUCT', 'description': 'At least six staff from each nursing home that assigned to the intervention group will be invited to attend two educational workshops. Participants in the intervention group will receive the following interventions.\n\n1. Face-to-face workshops: Five 1-hour educational workshops on physical activity will be delivered in months 1, 3, 5, 7 and 9 of the program held at each nursing home.\n2. Booklet: At the first educational workshop, each participant will be provided with a pictorial booklet.\n3. Exercise: The physical activity training consists of 50-60 min exercise sessions three times a week on non-consecutive days for 12 months.\n4. Others (newsletters, phone calls, and reminders): The intervention group will also receive newsletters containing myth dispelling information on osteoporosis and physical activity, motivational phone calls and a total of 52 SMS via mobile phones (reminders to attend workshop sessions and physical activity motivating messages) over 12 months.', 'armGroupLabels': ['Physical activity and education intervention']}, {'name': 'Education intervention', 'type': 'BEHAVIORAL', 'description': 'Participants in the control group will only receive educational materials (i.e. face-to-face workshops and booklet) and will be wait listed to receive no other interventions of this study until after the post-intervention.', 'armGroupLabels': ['Education intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li Tang, PhD', 'role': 'CONTACT', 'email': 'tangli207@hotmail.com', 'phone': '+8615002872018'}], 'overallOfficials': [{'name': 'Li Tang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu Jinjiang Maternity and Child Health Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Jinjiang Maternity and Child Health Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Li Tang', 'investigatorAffiliation': 'Chengdu Jinjiang Maternity and Child Health Hospital'}}}}