Osteoporosis Clinical Trial
Official title:
A Pilot and Feasibility Cluster Randomized Controlled Trial of Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
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.
n/a
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