Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients With Sarcopenia

Official title

Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients With Sarcopenia：a Randomized Controlled Trial

Overview

Introduction: The efficacy of existing therapies for the treatment of sarcopenia is still not satisfactory. Therefore, this randomized controlled, assessor-blinded study was designed to investigate the efficacy and safety of electroacupuncture(EA) therapy in elderly patients with sarcopenia. Methods and analysis: This randomized controlled trial will enroll 120 elderly patients with sarcopenia. Subjects will be randomly assigned in a 1:1 ratio to either EA combined with rehabilitation training group or rehabilitation training group through a central computerized randomization system. Primary outcome measure is lower limb mobility, including 6-minute walk test、timed get up and go test, and short physical performance battery. Secondary outcome measures include lower limb muscle mass and lower limb muscle strength. Outcome assessment will be conducted before the intervention, at 12 weeks after the intervention and at the end of the 12-week follow-up. Adverse reactions will be evaluated during the trial. Conclusion: This research will provide evidence to clarify whether EA is effective and safe in the treatment of sarcopenia.

Detailed description

Introduction: The efficacy of existing therapies for the treatment of sarcopenia is still not satisfactory. Therefore, this randomized controlled, assessor-blinded study was designed to investigate the efficacy and safety of electroacupuncture(EA) therapy in elderly patients with sarcopenia.

Methods and analysis: This randomized controlled trial will enroll 120 elderly patients with sarcopenia. The experimental group is EA combined with rehabilitation training group, while the control group is rehabilitation training group. Rehabilitation training is the more recognized treatment method for sarcopenia all over the world. Eligible subjects will be randomly assigned to two group in a 1:1 allocation ratio. All participants will undergo 12 weeks of treatments in two groups. This protocol is based on the standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and the SPIRIT reporting guidelines. Primary outcome measure is lower limb mobility, including 6-minute walk test、timed get up and go test, and short physical performance battery. Secondary outcome measures include lower limb muscle mass and lower limb muscle strength, such as lower extremity skeletal muscle mass、appendicular skeletal muscle mass、calf circumference、knee flexion and extension strength and grip strength. Outcome assessment will be conducted before the intervention, at 12 weeks after the intervention and at the end of the 12-week follow-up. Adverse reactions will be evaluated during the trial.

Conclusion: This research will provide evidence to clarify whether EA is effective and safe in the treatment of sarcopenia.

Interventions

• Device electroacupuncture
  Participants are required to be in the supine position. Routine disinfection first. Participants are then subjected to acupuncture and achieve deqi sensation at all acupuncture points. Four paired of acupuncture points (i.e. Biguan acupoints and Futu points; Yanglingquan acupoints and Zusanli acupoints, identical on both sides) are connected to the EA devices. EA parameter is set as sparse wave and frequency is 2Hz. The intensity of the EA is determined by the patients' tolerance. Needles will b
• Behavioral Rehabilitation Training
  The rehabilitation training group will be only treated with the Otago exercise program(OEP). Otago Exercise combines resistance exercise, balance training and aerobic walking and is an exercise prescription for elderly patients with sarcopenia. 1. Exercise: including warm-up exercise (5 minutes) + resistance exercise (20 minutes) + balance training (5 minutes). Training intensity: 30 minutes a day, 3 times a week, once every other day, 12 weeks of training period; resistance exercise gradually

Primary outcome measures

• 6min walk test [Time frame: 12 weeks]
• time to get up and go(TGUG) [Time frame: 12 weeks]
• short physical performance battery (SPPB) [Time frame: 12 weeks]

Secondary outcome measures (5)

• lower extremity skeletal muscle mass [Time frame: 12 weeks]
• appendicular skeletal muscle mass(ASMM) [Time frame: 12 weeks]
• calf circumference [Time frame: 12 weeks]
• knee flexion and extension strength [Time frame: 12 weeks]
• grip strength [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• 60 years ≤ age ≤ 95 years, male or female;
• Patients are able to walk and communicate independently, and can complete required rehabilitation training;
• Patients meet the diagnostic criteria proposed by the Asian Working Group for Sarcopenia(AWGS);
• Patients volunteer to participate in this study and sign the informed consent.

Exclusion criteria

• Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system;
• Patients with severe mental illness, cognitive impairment, and disorientation;
• Patients have trauma and unsuitable for sports;
• Patients with electronic devices or metal objects implanted in the body;
• Patients can't complete the required rehabilitation training;
• Patients cannot receive EA treatment due to any reasons
• Patients are participating in other drugs, acupuncture and massage trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou

Publications

• Wu W, Huang X, Fang L, Hu H, Han D. Electroacupuncture Plus Exercise for Sarcopenia in Older Adults: Protocol for a Randomized, Controlled, Assessor-Blinded Trial. Clin Interv Aging. 2025 Oct 23;20:1775-1786. doi: 10.2147/CIA.S545035. eCollection 2025. PMID 41164821

Identifiers

NCT: NCT05431010 · 2022ZB186

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗