AzTrials
AzTrials

FrailtyNCT07660653

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

A study testing Routine Health Education, Leucine-Enriched Whey Protein and Vitamin D Supplementation and Progressive Resistance Training in people with Frailty and Sarcopenia, run by Capital University of Physical Education and Sports, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Frailty, Sarcopenia, Mobility Limitation
What is being tested?
Routine Health Education, Leucine-Enriched Whey Protein and Vitamin D Supplementation and Progressive Resistance Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteChina
Study dates
18 Jun 2025to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Rural Community Sites in Jiaozuo, Henan

    Jiaozuo, Henan, 454000

Other trials in China

About this study

Official title: Effect of Resistance-Led Multicomponent Training Combined With Nutritional Supplementation on Intrinsic Capacity and Disability Risk in Chinese Rural Older Adults

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.

Read the detailed description

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.

Being tested
Routine Health Education, Isocaloric Placebo, Leucine-Enriched Whey Protein and Vitamin D Supplementation, Progressive Resistance Training, Resistance-Dominant Multicomponent Training
Keywords
Rural older adults, Resistance training, Multicomponent exercise, Whey protein
Medical subject headings
Frailty, Sarcopenia, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine Health EducationBehavioural

    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.

  • Isocaloric PlaceboDietary 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.

  • Leucine-Enriched Whey Protein and Vitamin D SupplementationDietary 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.

  • Progressive Resistance TrainingBehavioural

    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-Dominant Multicomponent TrainingBehavioural

    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.

Study groups in NCT07660653
Study groupRoleWhat they receive
Control GroupPlacebo comparatorParticipants in this group will receive routine health education and an isocaloric placebo without structured exercise training for 12 weeks.
Receives: Behavioral: Routine Health Education; Dietary Supplement: Isocaloric Placebo
Nutrition Supplementation GroupExperimentalParticipants in this group will receive leucine-enriched whey protein and vitamin D supplementation without structured exercise training for 12 weeks.
Receives: Dietary Supplement: Leucine-Enriched Whey Protein and Vitamin D Supplementation
Resistance Training GroupExperimentalParticipants in this group will receive supervised progressive resistance training three times per week for 12 weeks and an isocaloric placebo.
Receives: Dietary Supplement: Isocaloric Placebo; Behavioral: Progressive Resistance Training
Resistance Training Plus Nutrition GroupExperimentalParticipants 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.
Receives: Dietary Supplement: Leucine-Enriched Whey Protein and Vitamin D Supplementation; Behavioral: Progressive Resistance Training
Resistance-Dominant Multicomponent Training Plus Nutrition GroupExperimentalParticipants 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.
Receives: Dietary Supplement: Leucine-Enriched Whey Protein and Vitamin D Supplementation; Behavioral: Resistance-Dominant Multicomponent Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 12

  2. 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.

    Measured: Baseline and Week 12

  3. 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.

    Measured: Baseline and Week 12

  4. 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.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start18 Jun 2025
  3. Primary completion15 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07660653
Sponsor's protocol ID
CUPES-PY-2026520
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Routine Health Education, Leucine-Enriched Whey Protein and Vitamin D Supplementation and Progressive Resistance Training in people with Frailty and Sarcopenia, run by Capital University of Physical Education and Sports, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Short Physical Performance Battery Score at Week 12 (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in