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

Chengdu Jinjiang Maternity and Child Health Hospital

Status

Unknown

Conditions

Osteoporosis

Treatments

Combination Product: Physical activity and education intervention

Behavioral: Education intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04168658

201909

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

60 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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