A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
A Pilot and Feasibility Cluster Randomized Controlled Trial of Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedNovember 19, 2019
November 1, 2019
2.8 years
November 16, 2019
November 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Incidental falls
12 months starting from the baseline
Change in bone mineral density (BMD)
Baseline to 12 months post-baseline
Study Arms (2)
Physical activity and education intervention
EXPERIMENTALEducation intervention
ACTIVE COMPARATORInterventions
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. 1. 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. 2. Booklet: At the first educational workshop, each participant will be provided with a pictorial booklet. 3. Exercise: The physical activity training consists of 50-60 min exercise sessions three times a week on non-consecutive days for 12 months. 4. 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.
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.
Eligibility Criteria
You may qualify if:
- have at least 100 female residents aged 60 to 75 years
You may not qualify if:
- are participating in any other clinical trials
- female
- aged 60 to 75 years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Tang, PhD
Chengdu Jinjiang Maternity and Child Health Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 16, 2019
First Posted
November 19, 2019
Study Start
February 10, 2020
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
November 19, 2019
Record last verified: 2019-11