Clinical trial NCT06986395: Blood Flow Restriction Training for Age-Related Sarcopenia
Official title: The Efficacy of Blood Flow Restriction Training in Elderly Patients With Sarcopenia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia in Elderly
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)
  * 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

Primary outcomes:
measure: Change in Handgrip Strength
timeFrame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
Secondary outcomes:
measure: 6-Meter Walking Speed
timeFrame: Baseline (Week 0), Follow-up (Week 12)
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
measure: Timed Up and Go Test (TUG)
timeFrame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
measure: MBI
timeFrame: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
Other outcomes:
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