Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-01 @ 9:22 PM
Study NCT ID:
NCT04168658
Status:
UNKNOWN
Last Update Posted:
2019-11-19
First Post:
2019-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
Sponsor:
Chengdu Jinjiang Maternity and Child Health Hospital
Organization:
Study Overview
Official Title:
A Pilot and Feasibility Cluster Randomized Controlled Trial of Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: