Resistance-Based Multicomponent Training Plus Nutrition Supplementation for Intrinsic Capacity and Disability Risk in Chinese Rural Older Adults

NCT07660653 | Completed

• 1 other identifier: CUPES-PY-2026520
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rural older adults; Resistance training; Multicomponent exercise; Whey protein

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

Control Group

PLACEBO COMPARATOR

Participants in this group will receive routine health education and an isocaloric placebo without structured exercise training for 12 weeks.

Behavioral: Routine Health Education; Dietary Supplement: Isocaloric Placebo

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.

Dietary Supplement: Leucine-Enriched Whey Protein and Vitamin D Supplementation

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.

Dietary Supplement: Isocaloric Placebo; Behavioral: Progressive Resistance Training

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.

Dietary Supplement: Leucine-Enriched Whey Protein and Vitamin D Supplementation; Behavioral: Progressive Resistance Training

Resistance-Dominant Multicomponent Training Plus Nutrition Group

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.

Dietary Supplement: Leucine-Enriched Whey Protein and Vitamin D Supplementation; Behavioral: Resistance-Dominant Multicomponent Training

Interventions

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.

Control Group

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.

Control Group; Resistance Training Group

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.

Nutrition Supplementation Group; Resistance Training Plus Nutrition Group; Resistance-Dominant Multicomponent Training Plus Nutrition Group

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.

Resistance Training Group; Resistance Training Plus Nutrition Group

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.

Resistance-Dominant Multicomponent Training Plus Nutrition 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.
• Rural residents who have lived in the study area for at least 6 months and have no plan for long-term absence during the study period.
• Able to walk independently or with a cane for a short distance.
• Meeting at least one of the following risk characteristics: Short Physical Performance Battery score of 9 or lower, usual gait speed of 0.8 m/s or lower, Mini Nutritional Assessment Short Form score of 11 or lower, SARC-F score of 4 or higher, possible sarcopenia according to the Asian Working Group for Sarcopenia 2019 criteria, or FRAIL score of 1 to 3.
• Able to understand the study requirements and provide written informed consent.

You may not qualify if:

• Unstable cardiovascular or cerebrovascular events within the past 6 months.
• Severe uncontrolled hypertension, defined as resting systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher.
• Severe cognitive impairment that prevents understanding of or cooperation with the study procedures.
• Severe osteoarticular disease or neurological disease affecting exercise safety.
• Severe renal dysfunction, such as estimated glomerular filtration rate lower than 30 mL/min/1.73 m², or considered unsuitable for protein supplementation by the study physician.
• Hypercalcemia, active kidney stones, or contraindications to vitamin D supplementation.
• Allergy to whey protein or any component of the nutritional supplement.
• Regular use of protein powder, beta-hydroxy-beta-methylbutyrate, creatine, or other nutritional supplements that may affect muscle metabolism within the past 3 months.
• Participation in another interventional study.

Sponsors & Collaborators

• Capital University of Physical Education and Sports, China: lead

Study Sites (1)

Rural Community Sites in Jiaozuo, Henan

Jiaozuo, Henan, 454000, China

Location

MeSH Terms

Conditions

Frailty; Sarcopenia; Mobility Limitation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• yongzhao f, PhD

  Henan Normal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 18, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 31, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)