Clinical trial NCT04168658: A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
Official title: A Pilot and Feasibility Cluster Randomized Controlled Trial of Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis
Chinese women
nursing home
physical activity
RCT
Lead sponsor: Chengdu Jinjiang Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of habitual physical activity
timeFrame: Baseline to 12 months post-baseline
Secondary outcomes:
measure: Incidental falls
timeFrame: 12 months starting from the baseline
measure: Change in bone mineral density (BMD)
timeFrame: Baseline to 12 months post-baseline
Other outcomes:
Locations:
Study officials:
affiliation: Chengdu Jinjiang Maternity and Child Health Hospital
name: Li Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: