Resistance-Based Multicomponent Training Plus Nutrition Supplementation for Intrinsic Capacity and Disability Risk in Chinese Rural Older Adults
NCT07660653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-06-22
Summary
This study is a five-arm, parallel-group, assessor-blinded randomized controlled trial designed to evaluate the effects of resistance-dominant multicomponent training combined with nutritional supplementation on intrinsic capacity and disability risk among rural Chinese older adults. A total of 220 participants aged 60 years or older with mobility decline, nutritional risk, sarcopenia risk, or pre-frailty/frailty will be randomly assigned to one of five groups: control, nutrition supplementation alone, resistance training alone, resistance training plus nutrition supplementation, or resistance-dominant multicomponent training plus nutrition supplementation. The intervention will last 12 weeks. Exercise interventions will be conducted three times per week, and nutritional supplementation will include leucine-enriched whey protein and vitamin D. The primary outcomes are the Short Physical Performance Battery score, FRAIL score, and activities of daily living/instrumental activities of daily living scores. Secondary outcomes include gait speed, Timed Up and Go test, sit-to-stand performance, handgrip strength, nutritional status, protein intake, serum 25-hydroxyvitamin D, calf circumference, and appendicular skeletal muscle mass index.
Conditions
- Frailty
- Sarcopenia
- Mobility Limitation
- Nutritional Risk
Interventions
- BEHAVIORAL
-
Routine Health Education
Participants will receive routine health education during the 12-week study period. The health education will include general advice on healthy aging, physical activity safety, balanced diet, fall prevention, and chronic disease self-management. Participants will not receive structured exercise training or active nutritional supplementation as part of this intervention.
- DIETARY_SUPPLEMENT
-
Isocaloric Placebo
Participants will receive an isocaloric placebo that is similar to the active nutritional supplement in appearance, taste, packaging, and administration frequency. The placebo will be administered during the 12-week study period.
- DIETARY_SUPPLEMENT
-
Leucine-Enriched Whey Protein and Vitamin D Supplementation
Participants will receive a nutritional supplement containing approximately 20 g/day whey protein, 2.5 to 3.0 g/day total leucine, and 800 to 1000 IU/day vitamin D3. The supplement will be administered twice daily for 12 weeks. On training days, one dose will be taken within 30 minutes to 2 hours after exercise, and the other dose will be taken after breakfast. On non-training days, the supplement will be taken after breakfast and dinner.
- BEHAVIORAL
-
Progressive Resistance Training
Participants will complete supervised progressive resistance training three times per week for 12 weeks, with each session lasting 45 to 60 minutes. Exercises will include chair sit-to-stand, chair-assisted squat, calf raise, elastic-band knee extension, elastic-band hip abduction, elastic-band rowing, wall push-up, and shoulder press. Training intensity will progress from RPE 3-4/10 during weeks 1-4, to RPE 5-6/10 during weeks 5-8, and RPE 6-7/10 during weeks 9-12.
- BEHAVIORAL
-
Resistance-Dominant Multicomponent Training
Participants will complete supervised resistance-dominant multicomponent training three times per week for 12 weeks, with each session lasting 50 to 65 minutes. The program will use resistance training as the core component and will also include balance, gait, aerobic, flexibility, and breathing relaxation exercises. Each session will include approximately 25 to 30 minutes of resistance training, 8 to 10 minutes of balance and gait training, 8 to 10 minutes of aerobic exercise, and 5 minutes of stretching and relaxation.
Sponsors & Collaborators
-
Capital University of Physical Education and Sports, China
lead OTHER
Principal Investigators
-
yongzhao f, PhD · Henan Normal University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-18
- Primary Completion
- 2026-01-15
- Completion
- 2026-01-31
Countries
- China
Study Locations
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