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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.
This study aims to determine whether resistance-dominant multicomponent training combined with leucine-enriched whey protein and vitamin D supplementation can improve intrinsic capacity and reduce disability risk in rural Chinese older adults. The study focuses on the locomotion and vitality domains of intrinsic capacity, which are closely related to mobility function, nutritional status, muscle reserves, and the ability to maintain independent daily living.
Eligible participants will be rural community-dwelling adults aged 60 years or older who present at least one of the following risk characteristics: reduced physical performance, low gait speed, nutritional risk, sarcopenia risk, or pre-frailty/frailty. After baseline assessment, participants will be randomly allocated in a 1:1:1:1:1 ratio to one of five study groups: control group, nutrition supplementation group, resistance training group, resistance training plus nutrition supplementation group, and resistance-dominant multicomponent training plus nutrition supplementation group.
The traditional resistance training program will include progressive functional resistance exercises such as 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. The resistance-dominant multicomponent training program will use resistance training as the core component and will additionally include balance, gait, aerobic, flexibility, and breathing relaxation exercises. Exercise sessions will be conducted three times per week for 12 weeks.
The nutritional supplementation will consist of approximately 20 g/day whey protein, 2.5-3.0 g/day total leucine, and 800-1000 IU/day vitamin D3. The supplement will be administered twice daily. On training days, one dose will be taken within 30 minutes to 2 hours after exercise, and another dose after breakfast. On non-training days, the supplement will be taken after breakfast and dinner.
Outcome assessments will be performed at baseline and at week 12. 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 4-meter gait speed, Timed Up and Go test, five-times sit-to-stand test, 30-second chair stand test, handgrip strength, Mini Nutritional Assessment Short Form score, daily protein intake, serum 25-hydroxyvitamin D, body mass index, calf circumference, appendicular skeletal muscle mass index, and quality of life. Safety outcomes include renal function, blood calcium, falls, musculoskeletal injury, gastrointestinal symptoms, and other adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Participants in this group will receive routine health education and an isocaloric placebo without structured exercise training for 12 weeks. |
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| Nutrition Supplementation Group | Experimental | Participants in this group will receive leucine-enriched whey protein and vitamin D supplementation without structured exercise training for 12 weeks. |
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| Resistance Training Group | Experimental | Participants in this group will receive supervised progressive resistance training three times per week for 12 weeks and an isocaloric placebo. |
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| Resistance Training Plus Nutrition Group | Experimental | Participants in this group will receive supervised progressive resistance training three times per week for 12 weeks combined with leucine-enriched whey protein and vitamin D supplementation. |
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| Resistance-Dominant Multicomponent Training Plus Nutrition Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Health Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Short Physical Performance Battery Score at Week 12 | The Short Physical Performance Battery will be used to assess lower-extremity physical performance, including standing balance, 4-meter gait speed, and five-times sit-to-stand performance. Total scores range from 0 to 12, with higher scores indicating better physical performance. | Baseline and Week 12 |
| Change From Baseline in FRAIL Score at Week 12 | The FRAIL scale will be used to assess frailty status. The scale includes fatigue, resistance, ambulation, illness, and loss of weight. Scores range from 0 to 5, with higher scores indicating greater frailty risk. | Baseline and Week 12 |
| Change From Baseline in Activities of Daily Living Score at Week 12 | Activities of daily living will be assessed to evaluate basic self-care ability in daily life. Higher scores indicate better basic daily living function. | Baseline and Week 12 |
| Change From Baseline in Instrumental Activities of Daily Living Score at Week 12 | Instrumental activities of daily living will be assessed to evaluate more complex daily living abilities. Higher scores indicate better instrumental daily living function. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yongzhao f, PhD | Henan Normal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rural Community Sites in Jiaozuo, Henan | Jiaozuo | Henan | 454000 | China |
Individual participant data will not be shared because the study involves personal health information from rural older adults, and no formal data-sharing plan or participant consent for public data sharing has been established.
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This is a five-arm, parallel-group randomized controlled trial. Eligible rural older adults will be randomly assigned in a 1:1:1:1:1 ratio to one of five groups: control group, nutrition supplementation group, resistance training group, resistance training plus nutrition supplementation group, or resistance-dominant multicomponent training plus nutrition supplementation group. The intervention period will last 12 weeks.
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Due to the nature of the exercise intervention, participants and exercise instructors cannot be fully blinded to exercise allocation. Outcome assessors will be blinded to group assignment. For the nutritional supplementation component, the active supplement and the isocaloric placebo will be similar in appearance, taste, packaging, and administration frequency.
| Experimental |
Participants in this group will receive supervised resistance-dominant multicomponent training three times per week for 12 weeks combined with leucine-enriched whey protein and vitamin D supplementation. |
|
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| Isocaloric Placebo | Dietary Supplement | 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. |
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| Leucine-Enriched Whey Protein and Vitamin D Supplementation | Dietary Supplement | 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. |
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| Progressive Resistance Training | Behavioral | 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. |
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| Resistance-Dominant Multicomponent Training | Behavioral | 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. |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
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