SarcopeniaNCT05431010
Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients With Sarcopenia
A study testing electroacupuncture and Rehabilitation Training in people with Sarcopenia, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- electroacupuncture and Rehabilitation Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2022to 31 Dec 2026
- 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang
Wenzhe Wu, Master, 18757570729, 2008777.1378@163.com
About this study
Official title: Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients With Sarcopenia：a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- electroacupuncture, Rehabilitation Training
- Keywords
- sarcopenia；electroacupuncture; geriatric
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
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.
Rehabilitation TrainingBehavioural
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.
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Behavioral: Rehabilitation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 12 weeks
Secondary outcomes (5)
lower extremity skeletal muscle mass
The skeletal muscle mass of the lower limbs can be detected separately by applying the BCA body composition analyzer produced by Tsinghua Tongfang
Measured: 12 weeks
appendicular skeletal muscle mass(ASMM)
The BCA body composition analyzer produced by Tsinghua Tongfang can be used to directly test the skeletal muscle mass of the extremities.
Measured: 12 weeks
calf circumference
Measured by applying a measuring tape horizontally around the circumference of the thickest part of the calf
Measured: 12 weeks
knee flexion and extension strength
The TB-ISO multi-joint isometric strength testing system (made in Italy) was applied to test the peak moment/peak moment body weight ratio, average power, and total work for the isometric exercise of knee flexion and knee extension, respectively.
Measured: 12 weeks
grip strength
grip strength was obtained by grip strength measurement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start2 Jul 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenzhe Wu, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Wenzhe Wu, Master, Study director, The Third Affiliated hospital of Zhejiang Chinese Medical UniversityMing Guo, Doctor, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical SciencesHantong Hu, Doctor, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical UniversityHong Gao, Master, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical UniversityJinkuo Pang, Bachelor, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical UniversityYanfei Cao, Master, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical UniversityYiting Zhang, Master, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431010
- Sponsor's protocol ID
- 2022ZB186
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
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.
PubMed 41164821
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy on Walking Ability of Electroacupuncture Therapy in Elderly Patients With Sarcopenia：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05431010
- Acronym / sponsor ID
- 2022ZB186
- Conditions
- Sarcopenia
- Keywords
- sarcopenia；electroacupuncture; geriatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture and rehabilitation training | Experimental | Device: electroacupuncture, Behavioral: Rehabilitation TrainingParticipants 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 |
| rehabilitation training only | Active comparator | Behavioral: Rehabilitation TrainingThe 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). |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| electroacupunctureParticipants 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. | Device | electroacupuncture and rehabilitation training |
| Rehabilitation TrainingThe 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 | Behavioural | electroacupuncture and rehabilitation training, rehabilitation training only |
Primary outcome
6min walk test
Time frame: 12 weeks
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
time to get up and go(TGUG)
Time frame: 12 weeks
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.
short physical performance battery (SPPB)
Time frame: 12 weeks
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
5 secondary outcomes
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
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 24 Feb 2026.
- Derived from this study: PubMed 41164821Wu 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.
- Individual participant dataSharing planned: No. no plan
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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.
Wenzhe Wu, Master study director
The Third Affiliated hospital of Zhejiang Chinese Medical University
Ming Guo, Doctor principal investigator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Hantong Hu, Doctor principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture and Rehabilitation Training in people with Sarcopenia, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Wenzhe Wu, Master (18757570729, 2008777.1378@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6min walk test (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431010, which also lists 1 linked publication.
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 24 Feb 2026.