Community Smart Aging Model - Resistance Training

NCT07506538 | Active Not Recruiting

• 1 other identifier: UVIC-SLS-2024
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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 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. 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.

Conditions

Primary Osteoporosis

Keywords

Primary Osteoporosis; Resistance Training; Smart Community; Bone Mineral Density / BMD; Physical Function; Technology Acceptance; mHealth; Older Adults; SF-36

Outcome Measures

Primary Outcomes (2)

• Lumbar Spine Bone Mineral Density (BMD)

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

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

• Short Physical Performance Battery (SPPB) Score

  Assesses lower extremity function including static balance, 4-meter gait speed, and 5-time chair stand test. The total score ranges from 0 to 12. Higher scores indicate better physical function and lower fall risk.

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

Secondary Outcomes (4)

• Handgrip Strength (HGS)

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

• Health-Related Quality of Life (SF-36)

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

• Technology Acceptance Model (TAM) Score

  Baseline, 16 weeks, and 32 weeks

• eHealth Literacy Scale (eHEALS) Score

  Baseline and 32 weeks

Study Arms (2)

Smart Community-based Resistance Training Group

EXPERIMENTAL

Participants 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

Behavioral: Smart Community-Based Resistance Training

Routine Health Education Control Group

ACTIVE COMPARATOR

Participants 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.

Behavioral: Routine Health Education

Interventions

Smart Community-Based Resistance Training BEHAVIORAL

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.

Smart Community-based Resistance Training Group

Routine Health Education BEHAVIORAL

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.

Routine Health Education Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lingshu Sun: lead

Study Sites (1)

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

Tongliao, Inner Mongolia, 028000, China

Location

Related Publications (4)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an evaluator-blinded study. Due to the nature of the exercise intervention, participants and care providers cannot be masked. However, all clinical assessments (including DXA scans and physical tests) and data analysis are performed by independent researchers who are strictly blinded to the group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral students

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: August 1, 2025
• Primary Completion: March 23, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CN (1)