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

NCT05431010 | Recruiting DMC

• 1 other identifier: 2022ZB186
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Keywords

sarcopenia；electroacupuncture; geriatric

Outcome Measures

Primary Outcomes (3)

• 6min walk test

  The 6-min walking test setup is a straight line of 20 meters on a flat floor, and a chair is placed at each end as a sign. The subjects walk back and forth between them. The pace of walking is determined according to their own physical fitness, and they walk as fast as possible. In this way, the maximum walking distance that an individual can reach within 6 minutes will be texted

  12 weeks

• time to get up and go(TGUG)

  The TGUG test measures the time it takes for an individual to get up from a chair, complete a short 3 meters round-trip walk, and finally sit back in the chair.

  12 weeks

• short physical performance battery (SPPB)

  SPPB is a comprehensive test instrument that includes a walking speed test, a sit-to-stand test, and a balance test. The Walking Speed Test measures the time to pass a distance of 4 meters at daily walking speed. Sit-to-stand test is to calculate the time to complete 5 consecutive sets of getting up-sit down. The balance test includes 3 parts: 10 seconds for standing on the left and right side of both feet; standing on half front and half rear feet and standing on front and rear feet

  12 weeks

Secondary Outcomes (5)

• lower extremity skeletal muscle mass

  12 weeks

• appendicular skeletal muscle mass(ASMM)

  12 weeks

• calf circumference

  12 weeks

• knee flexion and extension strength

  12 weeks

• grip strength

  12 weeks

Study Arms (2)

electroacupuncture and rehabilitation training

EXPERIMENTAL

Participants in this group will received electroacupuncture（EA） combined with Otago exercise program(OEP). Acupuncture will be executed with size 0.30×40mm needle. EA will be performed with electronic acupuncture instruments

Device: electroacupuncture; Behavioral: Rehabilitation Training

rehabilitation training only

ACTIVE COMPARATOR

The rehabilitation group will be only treated with the Otago exercise program(OEP). The Otago Exercise is a program developed by the research group of fall prevention in the elderly led by Campbell of Otago Medical University in the 1990s. It is a home exercise program aimed at strengthening lower extremity muscle, balance and preventing falls in the elderly. Otago Exercise combines resistance exercise, balance training and aerobic walking and is an exercise prescription for elderly patients with sarcopenia (details are as follows).

Behavioral: Rehabilitation Training

Interventions

Rehabilitation Training BEHAVIORAL

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 increases the load. 2. Walking program: Take a walk. Activity intensity: 30 minutes each time, 2 times a week, combined with exercise (walking during the interval between exercise sessions), 12 weeks of training period

electroacupuncture and rehabilitation training; rehabilitation training only

electroacupuncture DEVICE

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 be left in place and each session of EA will last 30 minutes. Participants will undergo a total of 36 EA sessions, with the frequency of 3 sessions every week for 12 weeks.

electroacupuncture and rehabilitation training

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Wenzhe Wu, Master

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

• Ming Guo, Doctor

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

• Hantong Hu, Doctor

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

• Hong Gao, Master

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

• Jinkuo Pang, Bachelor

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

• Yanfei Cao, Master

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

• Yiting Zhang, Master

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenzhe Wu, Master

CONTACT

18757570729; 2008777.1378@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 24, 2022
• Study Start: July 2, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)