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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.
We 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.
A 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.
The 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.
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). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity and education intervention | Experimental |
| |
| Education intervention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity and education intervention | Combination Product | 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of habitual physical activity | 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). | Baseline to 12 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Incidental falls | 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". | 12 months starting from the baseline |
| Change in bone mineral density (BMD) |
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Inclusion Criteria (cluster level-nursing home):
Exclusion Criteria (cluster level-nursing home):
Inclusion Criteria (participant level):
Exclusion Criteria (participant level):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Tang, PhD | Contact | +8615002872018 | tangli207@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Tang, PhD | Chengdu Jinjiang Maternity and Child Health Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Education intervention | Behavioral | 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. |
|
BMD (g/cm2) of lumbar spine (L1-L4) and proximal femoral neck
| Baseline to 12 months post-baseline |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001519 | Behavior |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |