A Physical Activity Program for Female Nursing Home Residents at Risk of Osteoporosis

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04168658
• Other study ID #: 201909
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: June 2023

Study information

• Verified date: November 2019
• Source: Chengdu Jinjiang Maternity and Child Health Hospital
• Contact: Li Tang, PhD
• Phone: +8615002872018
• Email: tangli207[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Combination Product:
• Physical activity and education intervention
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.

Behavioral:
• Education intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Jinjiang Maternity and Child Health Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".	12 months starting from the baseline
Secondary	Change in bone mineral density (BMD)	BMD (g/cm2) of lumbar spine (L1-L4) and proximal femoral neck	Baseline to 12 months post-baseline