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

November 16, 2019 updated by: Li Tang, Chengdu Jinjiang Maternity and Child Health Hospital

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Physical activity and education 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.

  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.
ACTIVE_COMPARATOR: Education intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline to 12 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidental falls
Time Frame: 12 months starting from the baseline
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
Change in bone mineral density (BMD)
Time Frame: Baseline to 12 months post-baseline
BMD (g/cm2) of lumbar spine (L1-L4) and proximal femoral neck
Baseline to 12 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Jinjiang Maternity and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 10, 2020

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

November 16, 2019

First Submitted That Met QC Criteria

November 16, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 16, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201909

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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