Sarcopenia in ElderlyNCT06986395
Blood Flow Restriction Training for Age-Related Sarcopenia
A study testing Blood Flow Restriction Training (BFRT) and Conventional Resistance Training (CRT) in people with Sarcopenia in Elderly, run by West China Hospital.
Trial summary
Brief Title: Safe Exercise for Age-Related Muscle Loss in Hospitalized Seniors Summary: This study compares two exercise methods to help older hospital patients (age 65+) rebuild muscle strength after being diagnosed with sarcopenia (age-related muscle loss). Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- Blood Flow Restriction Training (BFRT) and Conventional Resistance Training (CRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized patients aged ≥65 years
- Diagnosed with sarcopenia per EWGSOP2019 criteria
- Acute medical conditions stabilized for ≥4 weeks (e.g., resolved infections, controlled heart failure)
Who cannot join
- Severe disability (Barthel Index ≤40)
- Significant cognitive impairment (MMSE ≤18) or major psychiatric disorders (DSM-5 criteria)
- Contraindications to blood flow restriction training:
- History/predisposition to deep vein thrombosis
- Coagulopathy (INR >1.5, platelets <100×10⁹/L)
- Symptomatic varicose veins (CEAP class C4-C6)
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- Uncontrolled hypertension (BP >160/100 mmHg)
- Chronic lymphedema (ISL stage II-III)
- Peripheral artery disease (ABI ≤0.7)
- Active systemic infection (CRP >10 mg/L)
- Malignancy (except non-melanoma skin cancer)
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Acute coronary syndrome within 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Blood Flow Restriction Training in Elderly Patients With Sarcopenia.
Brief Title: Safe Exercise for Age-Related Muscle Loss in Hospitalized Seniors
Summary:
Read more
This study compares two exercise methods to help older hospital patients (age 65+) rebuild muscle strength after being diagnosed with sarcopenia (age-related muscle loss). We want to know if using special pressure cuffs during light exercise works better than traditional strength training alone.
Who Can Join:
Hospitalized seniors with stable health conditions Excludes those with severe disabilities, dementia, or certain blood circulation problems
What We'll Do:
40 participants will be randomly assigned to either:
Traditional Training Group:
Uses weights/bands at 65-75% max capacity Arm/leg exercises 3x/week for 4 weeks
Pressure Cuff Training Group:
Uses special cuffs on arms/thighs during lighter exercises (20% max capacity) Same exercise frequency with controlled pressure for safety
What We'll Measure:
Handgrip strength (main test at 0/4/12 weeks) Walking speed, balance tests, quality of life surveys Any side effects like dizziness/nausea
Safety First:
Doctors will check your health before starting. Nurses will monitor every session. We use medical-grade cuffs with safe pressure limits (arm: 80-100mmHg, thigh: 150-200mmHg). You can stop anytime if uncomfortable.
Why This Matters:
This could help hospitalized seniors regain strength faster using gentler exercises. All activities are supervised by rehabilitation specialists at West China Hospital, with ethics committee approval (IRB number required).
- Conditions
- Sarcopenia in Elderly
- Being tested
- Blood Flow Restriction Training (BFRT), Conventional Resistance Training (CRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Training (BFRT)Device
Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands
Conventional Resistance Training (CRT)Other
Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands
| Study group | Role | What they receive |
|---|---|---|
| BFRT Group | Experimental | "Blood flow restriction training with 20% 1RM loading, pneumatic cuff pressure 80-100mmHg (arms) Receives: Device: Blood Flow Restriction Training (BFRT) |
| CRT Group | Active comparator | Conventional resistance training at 65-75% 1RM intensity using weights/elastic bands, matched frequency/duration Receives: Other: Conventional Resistance Training (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Handgrip Strength
Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
Secondary outcomes (4)
6-Meter Walking Speed
Measured: Baseline (Week 0), Follow-up (Week 12)
Short Physical Performance Battery (SPPB)
Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
Timed Up and Go Test (TUG)
Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
MBI
Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study startMay 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxiang Liang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986395
- Sponsor's protocol ID
- 20241201
- Status last verified
- Jan 2025
- First submitted
- 20 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Blood Flow Restriction Training in Elderly Patients With Sarcopenia.
- ClinicalTrials.gov ID
- NCT06986395
- Acronym / sponsor ID
- 20241201
- Conditions
- Sarcopenia in Elderly
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Title: Safe Exercise for Age-Related Muscle Loss in Hospitalized Seniors
Summary:
This study compares two exercise methods to help older hospital patients (age 65+) rebuild muscle strength after being diagnosed with sarcopenia (age-related muscle loss). We want to know if using special pressure cuffs during light exercise works better than traditional strength training alone.
Who Can Join:
Hospitalized seniors with stable health conditions Excludes those with severe disabilities, dementia, or certain blood circulation problems
What We'll Do:
40 participants will be randomly assigned to either:
Traditional Training Group:
Uses weights/bands at 65-75% max capacity Arm/leg exercises 3x/week for 4 weeks
Pressure Cuff Training Group:
Uses special cuffs on arms/thighs during lighter exercises (20% max capacity) Same exercise frequency with controlled pressure for safety
What We'll Measure:
Handgrip strength (main test at 0/4/12 weeks) Walking speed, balance tests, quality of life surveys Any side effects like dizziness/nausea
Safety First:
Doctors will check your health before starting. Nurses will monitor every session. We use medical-grade cuffs with safe pressure limits (arm: 80-100mmHg, thigh: 150-200mmHg). You can stop anytime if uncomfortable.
Why This Matters:
This could help hospitalized seniors regain strength faster using gentler exercises. All activities are supervised by rehabilitation specialists at West China Hospital, with ethics committee approval (IRB number required).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFRT Group | Experimental | Device: Blood Flow Restriction Training (BFRT)"Blood flow restriction training with 20% 1RM loading, pneumatic cuff pressure 80-100mmHg (arms) |
| CRT Group | Active comparator | Other: Conventional Resistance Training (CRT)Conventional resistance training at 65-75% 1RM intensity using weights/elastic bands, matched frequency/duration |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Hospitalized patients aged ≥65 years
- Diagnosed with sarcopenia per EWGSOP2019 criteria
- Acute medical conditions stabilized for ≥4 weeks (e.g., resolved infections, controlled heart failure)
Key exclusion criteria (13 listed)
- Severe disability (Barthel Index ≤40)
- Significant cognitive impairment (MMSE ≤18) or major psychiatric disorders (DSM-5 criteria)
- Contraindications to blood flow restriction training:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction Training (BFRT)Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands | Device | BFRT Group |
| Conventional Resistance Training (CRT)Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands | Other | CRT Group |
Primary outcome
Change in Handgrip Strength
Time frame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
4 secondary outcomes
6-Meter Walking Speed
Time frame: Baseline (Week 0), Follow-up (Week 12)
Short Physical Performance Battery (SPPB)
Time frame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
Timed Up and Go Test (TUG)
Time frame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
MBI
Time frame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training (BFRT) and Conventional Resistance Training (CRT) in people with Sarcopenia in Elderly, run by West China Hospital.
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 3 inclusion and 13 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: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yu liang (+86 13982250862, 1536569213@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Handgrip Strength (time frame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)). 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 23 May 2025.