OsteoporosisNCT04168658
A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
A study testing Physical activity and education intervention and Education intervention in people with Osteoporosis, run by Chengdu Jinjiang Maternity and Child Health Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Physical activity and education intervention and Education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2020to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have at least 100 female residents aged 60 to 75 years
- female
- aged 60 to 75 years
Who cannot join
- are participating in any other clinical trials
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Conditions
- Osteoporosis
- Being tested
- Physical activity and education intervention, Education intervention
- Keywords
- Osteoporosis, Chinese women, nursing home, physical activity, RCT
- Medical subject headings
- Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and education interventionCombination 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.
- 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.
Education interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity and education intervention | Experimental | Not described Receives: Combination Product: Physical activity and education intervention |
| Education intervention | Active comparator | Not described Receives: Behavioral: Education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 12 months post-baseline
Secondary outcomes (2)
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".
Measured: 12 months starting from the baseline
Change in bone mineral density (BMD)
BMD (g/cm2) of lumbar spine (L1-L4) and proximal femoral neck
Measured: Baseline to 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start10 Feb 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Tang, Chengdu Jinjiang Maternity and Child Health Hospital
- Investigators
- Li Tang, PhD, Principal investigator, Chengdu Jinjiang Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168658
- Sponsor's protocol ID
- 201909
- Status last verified
- Nov 2019
- First submitted
- 16 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Cluster Randomized Controlled Trial of Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
- ClinicalTrials.gov ID
- NCT04168658
- Acronym / sponsor ID
- 201909
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Chinese women, nursing home, physical activity, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity and education intervention | Experimental | Combination Product: Physical activity and education intervention |
| Education intervention | Active comparator | Behavioral: Education intervention |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have at least 100 female residents aged 60 to 75 years
- female
- aged 60 to 75 years
Key exclusion criteria (7 listed)
- are participating in any other clinical trials
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity and education interventionAt 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. | Combination product | Physical activity and education intervention |
| Education interventionParticipants 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. | Behavioural | Education intervention |
Primary outcome
Change of habitual physical activity
Time frame: Baseline to 12 months post-baseline
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).
2 secondary outcomes
Incidental falls
Time frame: 12 months starting from the baseline
Change in bone mineral density (BMD)
Time frame: Baseline to 12 months post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Tang, PhD principal investigator
Chengdu Jinjiang Maternity and Child Health Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and education intervention and Education intervention in people with Osteoporosis, run by Chengdu Jinjiang Maternity and Child Health Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Tang, PhD (+8615002872018, tangli207@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of habitual physical activity (time frame: Baseline to 12 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.