A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot and Feasibility Cluster Randomized Controlled Trial of Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Combination Product: Physical activity and education intervention
* Behavioral: Education intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (cluster level-nursing home): have at least 100 female residents aged 60 to 75 years Exclusion Criteria (cluster level-nursing home): are participating in any other clinical trials Inclusion Criteria (participant level): female aged 60 to 75 years Exclusion Criteria (participant level): have a previous diagnosis of osteoporosis are osteoporotic are taking medicines that would affect calcium or bone metabolism are already physically active (i.e. exercise at least three times a week at a moderate or higher intensity for ≥ 30 min) have taken part in any physical activity program within the past year sustain any medical condition that would put them at risk by taking part in moderate intensity exercises

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity and education intervention<br> | Combination Product: Physical activity and education intervention<br>* 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. 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. Booklet: At the first educational workshop, each participant will be provided with a pictorial booklet. Exercise: The physical activity training consists of 50-60 min exercise sessions three times a week on non-consecutive days for 12 months. 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.<br>|
| Active Comparator: Education intervention<br> | Behavioral: Education intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | BMD (g/cm2) of lumbar spine (L1-L4) and proximal femoral neck | Baseline to 12 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Chinese women, nursing home, physical activity, RCT