AzTrials
AzTrials

Primary OsteoporosisNCT07506538

Community Smart Aging Model - Resistance Training

A study testing Smart Community-Based Resistance Training and Routine Health Education in people with Primary Osteoporosis, run by Lingshu Sun at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This clinical trial aims to evaluate the effectiveness of a smart community-based resistance training program in older adults aged 60 and older with primary osteoporosis. The main questions it aims to answer are: Does the 32-week smart resistance training improve lumbar spine bone mineral density (BMD)? Does the… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Primary Osteoporosis
What is being tested?
Smart Community-Based Resistance Training and Routine Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteChina
Study dates
1 Aug 2025to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 60 years or older.
  • Diagnosed with primary osteoporosis via DXA scan (lumbar spine or hip T-score ≤ -2.5, or ≤ -2.0 with a fragility fracture history).
  • Possess basic smartphone operation skills. Normal basic cognitive ability (MMSE score ≥ 24) and capable of independent walking.
  • Reside in the designated community without relocation plans within the next year.
  • Voluntarily sign the informed consent form.

Who cannot join

  • Diagnosed with secondary osteoporosis.
  • Recent major medical events (e.g., fractures or hip/spine surgery within the past 3 months) or uncontrolled severe cardiovascular diseases.
  • Completely unable to operate smart devices due to severe sensory or communication impairments.
  • Currently participating in similar exercise interventions or clinical trials.
  • Terminal illness or life expectancy of less than 1 year.
  • Lack of support or consent from children or guardians.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Inner Mongolia Changxiao Smart Elderly Care Service Co., Ltd.

    Tongliao, Inner Mongolia, 028000

Other trials in China

About this study

Official title: Based on the Community Smart Aging Model: A Study on the Application of Resistance Training to Elderly People With Primary Osteoporosis

This clinical trial aims to evaluate the effectiveness of a smart community-based resistance training program in older adults aged 60 and older with primary osteoporosis. The main questions it aims to answer are:

Does the 32-week smart resistance training improve lumbar spine bone mineral density (BMD)? Does the training improve lower extremity physical function? Researchers will compare the smart resistance training group with a routine health education control group to see if the resistance training effectively improves bone health and physical capabilities.

Read more

Participants will:

Be randomly assigned to either the resistance training group or the health education group.

If in the training group: Wear a smart health bracelet and complete 40 to 60 minutes of elastic band resistance training 3 times a week for 32 weeks, with guidance from smart devices and community staff.

If in the health education group: Maintain usual daily activities and attend a monthly group health education lecture on osteoporosis.

Complete clinical assessments, including bone density scans (DXA), physical performance tests, and questionnaires at the start, at 16 weeks, and at 32 weeks.

Enter a 12-month observational follow-up phase after the 32-week intervention to evaluate the long-term sustainability of the outcomes.

Read the detailed description

Primary osteoporosis presents a significant global public health burden. Resistance training effectively improves bone mineral density (BMD) and physical function in older adults. Traditional supervised training programs face practical barriers regarding spatial accessibility, temporal constraints, and long-term adherence. Mobile health (mHealth) and smart community facilities offer scalable solutions for home-based interventions. The clinical efficacy of high-intensity digital exercise prescriptions and the specific mechanistic role of technology acceptance require rigorous validation through randomized controlled trials.

This study is a single-center, single-blind, parallel-group randomized controlled trial. 98 older adults diagnosed with primary osteoporosis will be recruited from a smart elderly care community. Participants will be randomly assigned to either an intervention group or a control group. The study consists of a 32-week core intervention period followed by a 12-month observational follow-up phase to evaluate long-term effectiveness.

The intervention group will undergo a smart community-based resistance training program. Participants will complete 40 to 60 minutes of structured elastic band training 3 times a week. The protocol applies progressive overload, starting at 50-60% of 1-repetition maximum (1RM) and advancing to 70-80% 1RM. Smart health bracelets and mobile applications will deliver standardized video demonstrations, monitor real-time physiological metrics, and track attendance. Community staff holding fitness certifications will provide periodic offline coaching, error correction, and safety supervision.

The control group will receive routine care. Participants will maintain their usual daily activities and attend a monthly offline group seminar covering osteoporosis prevention, nutrition, and fall prevention strategies.

The primary objective is to evaluate longitudinal changes in lumbar spine BMD and physical performance, measured by the Short Physical Performance Battery (SPPB), at 16 and 32 weeks. Secondary objectives include assessing upper limb handgrip strength, health-related quality of life (SF-36), and dimensions of technology acceptance during the intervention and the subsequent 12-month follow-up period. The study will utilize mediation models and machine learning frameworks to explore whether baseline technology acceptance directly influences clinical outcomes or serves as an antecedent driving initial adherence.

Being tested
Smart Community-Based Resistance Training, Routine Health Education
Keywords
Primary Osteoporosis, Resistance Training, Smart Community, Bone Mineral Density / BMD, Physical Function, Technology Acceptance, mHealth, Older Adults, SF-36

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart Community-Based Resistance TrainingBehavioural

    Participants complete a 32-week resistance training program using elastic bands. Sessions occur 3 times per week, lasting 40-60 minutes each. The training intensity progressively increases from 50-60% of 1RM to 70-80% of 1RM. A smart health bracelet and mHealth application monitor heart rate and adherence in real-time.

  • Routine Health EducationBehavioural

    Participants maintain their usual daily activities without structured resistance training. Participants attend monthly 60-minute group health education lectures. The lectures cover osteoporosis knowledge, physical activity benefits, and fall prevention strategies.

Study groups in NCT07506538
Study groupRoleWhat they receive
Smart Community-based Resistance Training GroupExperimentalParticipants in this arm will receive a 32-week high-intensity resistance training program. The training consists of 9 specific exercises using elastic bands, covering major muscle groups of the spine and limbs. Frequency is 3 sessions per week, with each session lasting 40-60 minutes. Intensity starts at 50-60% 1RM and progresses to 70-80% 1RM. Smart health bracelets and mobile apps are used for real-time monitoring and adherence tracking. After the 32-week intervention, participants will enter a 12-month observational follow-up period
Receives: Behavioral: Smart Community-Based Resistance Training
Routine Health Education Control GroupActive comparatorParticipants in this arm will maintain their usual daily activities without structured resistance training. They will attend one offline group health education seminar per month. Topics include osteoporosis prevention, nutrition (calcium/Vitamin D intake), and fall prevention strategies. After the 32-week study period, they will also participate in the 12-month observational follow-up phase.
Receives: Behavioral: Routine Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lumbar Spine Bone Mineral Density (BMD)

    Measured by Dual-energy X-ray Absorptiometry (DXA). The absolute BMD value is reported in g/cm².

    Measured: Baseline ，16 weeks ，32 weeks and Follow-up ended (12 months after the 32-week intervention).

  2. Short Physical Performance Battery (SPPB) Score

    The Short Physical Performance Battery (SPPB) assesses lower extremity function through three tests: static balance, 4-meter gait speed, and 5-time chair stand. The total score ranges from a minimum of 0 to a maximum of 12. Higher scores indicate better physical function and lower fall risk.

    Measured: Baseline, 16 weeks, 32 weeks and Follow-up ended (12 months after the 32-week intervention).

Secondary outcomes (4)

  1. Handgrip Strength (HGS)

    Maximum isometric muscle strength of the dominant hand measured by an electronic hand dynamometer. The value is reported in kilograms (kg).

    Measured: Baseline, 16 weeks, 32 weeks and Follow-up ended (12 months after the 32-week intervention).

  2. Health-Related Quality of Life (SF-36)

    The 36-Item Short Form Health Survey (SF-36) assesses eight dimensions of health. The individual dimension scores are aggregated and converted to a scale ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life.

    Measured: Baseline, 16 weeks, 32 weeks and Follow-up ended (12 months after the 32-week intervention).

  3. Technology Acceptance Model (TAM) Score

    The Technology Acceptance Model (TAM) questionnaire assesses perceived usefulness and perceived ease of use using 10 items. Each item is scored on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The total score ranges from a minimum of 10 to a maximum of 70. Higher scores indicate stronger technology acceptance.

    Measured: Baseline, 16 weeks, and 32 weeks

  4. eHealth Literacy Scale (eHEALS) Score

    The eHealth Literacy Scale (eHEALS) assesses the ability to seek, understand, and apply digital health information using 8 items. Each item is scored on a 5-point Likert scale. The total score ranges from a minimum of 8 to a maximum of 40. Higher scores indicate higher levels of perceived eHealth literacy.

    Measured: Baseline and 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start1 Aug 2025
  3. Primary completion23 Mar 2026
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-center, single-blind, parallel-group randomized controlled trial with a 1:1 allocation ratio. 98 eligible older adults with primary osteoporosis are randomly assigned to either the smart community-based resistance training group or the routine health education control group. The study consists of a 32-week active intervention phase, followed by a 12-month observational follow-up period to assess the long-term sustainability of the outcomes.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07506538
Sponsor's protocol ID
UVIC-SLS-2024
Status last verified
Apr 2026
First submitted
26 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data sharing is subject to approval by the local Civil Affairs Bureau and the project's cooperating community center. Since the study is integrated into a government-supported community elderly care pilot, individual participant data (IPD) can only be shared after ensuring full compliance with local administrative regulations and obtaining explicit authorization from the relevant authorities. A final decision will be made upon the completion of the project and internal review.

Publications

  • Outcomes & Methodology 22.Guralnik JM, Simonsick EM, Ferrucci L, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49(2):M85-M94. 23.Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473-483. 24.Cruz-Jentoft AJ, Bahat G, Bauer J, et al. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019;48(1):16-31. 25.CONSORT Group. CONSORT 2025 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. London: BMJ Publishing Group; 2025. 26.Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update. Endocr Pract. 2020;26(Suppl 1):1-46. 27.Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175-191. 28.Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40(3):879-891. 29.Tibshirani R. Regression shrinkage and selection via the lasso. J R Stat Soc Series B Stat Methodol. 1996;58(1):267-288. 30.Li N, Beaudart C, Cauley JA, et al. Cost-effectiveness analyses of interventions for osteoporosis in men: a systematic literature review. PharmacoEconomics. 2023;41(4):363-391.

  • Technology Acceptance & mHealth 16.Davis FD. Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Q. 1989;13(3):319-340. 17.Kayser L, Karnoe A, Furstrand D, et al. A multidimensional tool based on the eHealth literacy framework: development and initial validity testing of the eHealth Literacy Questionnaire (eHLQ). J Med Internet Res. 2018;20(2):e36. 18.Norman CD, Skinner HA. eHEALS: the eHealth Literacy Scale. J Med Internet Res. 2006;8(4):e27. 19.Ferrari L, Bochicchio G, Bottari A, et al. Feasibility and effectiveness of a 6-month, home-based, resistance exercise delivered by a remote technological solution in healthy older adults. Arch Gerontol Geriatr. 2024;127:105559. 20.Venkatesh V, Davis FD. A theoretical extension of the technology acceptance model: four longitudinal field studies. Manage Sci. 2000;46(2):186-204. 21.Deka P, Salahshurian E, Ng T, et al. Use of mHealth technology for improving exercise adherence in patients with heart failure: systematic review. J Med Internet Res. 2025;27:e54524.

  • RT Mechanisms & Evidence 8.Hong AR, Kim SW. Effects of resistance exercise on bone health. Endocrinol Metab (Seoul). 2018;33(4):435-444. 9.Borde R, Hortobágyi T, Granacher U. Dose-response relationships of resistance training in healthy old adults: a systematic review and meta-analysis. Sports Med. 2015;45(12):1693-1720. 10.Zhao F, Su W, Sun Y, et al. Optimal resistance training parameters for improving bone mineral density in postmenopausal women: a systematic review and meta-analysis. J Orthop Surg Res. 2025;20(1):523. 11.Hu L, Chen W, Qian A, Li Y. Wnt/β-catenin signaling components and mechanisms in bone formation, homeostasis, and disease. Bone Res. 2024;12(1):1-33. 12.Mende E, Moennig N, Schaller N, et al. Progressive machine-based resistance training for prevention and treatment of sarcopenia in the oldest old: a systematic review and meta-analysis. Exp Gerontol. 2022;163:111767. 13.Liu CJ, Shiroy DM, Jones LY, Doerfler ET. Systematic review of functional training on muscle strength, physical functioning, and activities of daily living in older adults. Eur Rev Aging Phys Act. 2014;11(2):95-106. 14.Sadaqa M, Németh Z, Makai A, et al. Effectiveness of exercise interventions on fall prevention in ambulatory community-dwelling older adults: a systematic review with narrative synthesis. Front Public Health. 2023;11:1209319. 15.Forwood MR, Turner CH. Skeletal adaptations to mechanical usage: results from tibial loading studies in rats. Bone. 1995;17(4 Suppl):197S-205S.

  • Epidemiology & Burden 1.Salari N, Darvishi N, Bartina Y, et al. Global prevalence of osteoporosis among the world older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res. 2021;16(1):669. 2.Sing CW, et al. Global epidemiology of hip fractures: secular trends in incidence rate, post-fracture treatment, and all-cause mortality. J Bone Miner Res. 2023;38(8):1064-1075. 3.Yin Y, Wang Y, Wang X, et al. Prevalence rate of primary osteoporosis in China: a meta-analysis. BMC Public Health. 2024;24(1):1518. 4.Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006;17(12):1726-1733. 5.National Bureau of Statistics of China. Communiqué of the Seventh National Population Census (No. 5). Published May 11, 2021. 6.World Health Organization. WHO Integrated Care for Older People (ICOPE): Guidance for Person-Centred Assessment and Pathways in Primary Care. Geneva: World Health Organization; 2023. 7.Shen Y, Huang X, Wu J, et al. The global burden of osteoporosis, low bone mass, and its related fracture in 204 countries and territories, 1990-2019. Front Endocrinol (Lausanne). 2022;13:882241.

Questions about this trial

What is this clinical trial studying?

A study testing Smart Community-Based Resistance Training and Routine Health Education in people with Primary Osteoporosis, run by Lingshu Sun at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lumbar Spine Bone Mineral Density (BMD) (time frame: Baseline ，16 weeks ，32 weeks and Follow-up ended (12 months after the 32-week intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07506538, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in