Primary Osteoporosis
Conditions
Keywords
Primary Osteoporosis, Resistance Training, Smart Community, Bone Mineral Density / BMD, Physical Function, Technology Acceptance, mHealth, Older Adults, SF-36
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.
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.
Interventions
BEHAVIORALSmart Community-Based Resistance Training
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.
BEHAVIORALRoutine Health Education
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.
Sponsors
Lingshu Sun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar Spine Bone Mineral Density (BMD) | Baseline ，16 weeks ，32 weeks and Follow-up ended (12 months after the 32-week intervention). | Measured by Dual-energy X-ray Absorptiometry (DXA). The absolute BMD value is reported in g/cm². |
| Short Physical Performance Battery (SPPB) Score | Baseline, 16 weeks, 32 weeks and Follow-up ended (12 months after the 32-week intervention). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip Strength (HGS) | Baseline, 16 weeks, 32 weeks and Follow-up ended (12 months after the 32-week intervention). | Maximum isometric muscle strength of the dominant hand measured by an electronic hand dynamometer. The value is reported in kilograms (kg). |
| Health-Related Quality of Life (SF-36) | Baseline, 16 weeks, 32 weeks and Follow-up ended (12 months after the 32-week intervention). | 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. |
| Technology Acceptance Model (TAM) Score | Baseline, 16 weeks, and 32 weeks | 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. |
| eHealth Literacy Scale (eHEALS) Score | Baseline and 32 weeks | 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. |
Countries
China
Outcome results
None listed