Blood Flow Restriction Training for Age-Related Sarcopenia

NCT06986395 | Not Yet Recruiting DMC

• 1 other identifier: 20241201
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Sarcopenia in Elderly

Outcome Measures

Primary Outcomes (1)

• Change in Handgrip Strength

  Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)

Secondary Outcomes (4)

• 6-Meter Walking Speed

  Baseline (Week 0), Follow-up (Week 12)

• Short Physical Performance Battery (SPPB)

  Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)

• Timed Up and Go Test (TUG)

  Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)

• MBI

  Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)

Study Arms (2)

BFRT Group

EXPERIMENTAL

"Blood flow restriction training with 20% 1RM loading, pneumatic cuff pressure 80-100mmHg (arms)

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

Other: Conventional Resistance Training (CRT)

Interventions

Blood Flow Restriction Training (BFRT) DEVICE

Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands

BFRT Group

Conventional Resistance Training (CRT) OTHER

Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands

CRT Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

yu liang

CONTACT

+86 13982250862; 1536569213@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist-in-Charge

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 23, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 10, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-01