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Active Not RecruitingNCT07506538

Community Smart Aging Model - Resistance Training

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Lingshu Sun · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSmart Community-Based Resistance TrainingParticipants 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 EducationParticipants 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.

Timeline

Start date
2025-08-01
Primary completion
2026-03-23
Completion
2027-04-01
First posted
2026-04-01
Last updated
2026-04-07

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07506538. Inclusion in this directory is not an endorsement.