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A multicenter, randomized controlled trial investigating the clinical efficacy and safety of acupuncture treatment for sarcopenia in the elderly

Registration number：

ITMCTR2024000374

Date of Last Refreshed on：

2024-09-04

Date of Registration：

2024-09-04

Registration Status：

Retrospective registration

Public title：

A multicenter, randomized controlled trial investigating the clinical efficacy and safety of acupuncture treatment for sarcopenia in the elderly

English Acronym：

Scientific title：

A multicenter, randomized controlled trial investigating the clinical efficacy and safety of acupuncture treatment for sarcopenia in the elderly

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yangchi Li

Study leader：

Wenxiong Li

Applicant telephone：

18402987629

Study leader's telephone：

15706016769

Applicant Fax：

Study leader's fax：

Applicant E-mail：

847305497@qq.com

Study leader's E-mail：

liwenxiong55@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Shaanxi Province Xianyang City Qindao District Shaanxi University of Traditional Chinese Medicine North Campus

Study leader's address：

Shaanxi Province Xianyang City Qindao District Chen Yangzhai Street Shaanxi University of Traditional Chinese Medicine South Campus

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shaanxi University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

SZFYIEC-PJ-2024年第[156]号

Approved file of Ethical Committee：

View

Name of the ethic committee：

IEC of The Affiliated Hospital of Shaanxi University of Chinese Medicine

Date of approved by ethic committee：

2024/7/29 0:00:00

Contact Name of the ethic committee：

Huihui Zhong

Contact Address of the ethic committee：

Affiliated Hospital of Shaanxi University of Chinese Medicine, Qindu District, Xianyang City, Shaanxi Province

Contact phone of the ethic committee：

029-33377941

Contact email of the ethic committee：

szfyllwyh@163.com

Primary sponsor：

Affiliated Hospital of Shaanxi University of Chinese Medicine

Primary sponsor's address：

Affiliated Hospital of Shaanxi University of Chinese Medicine, Qindu District, Xianyang City, Shaanxi Province

Secondary sponsor：

Country：

Chinese

Province：

Shaanxi Province

City：

Xianyang City

Institution
hospital：

Affiliated Hospital of Shaanxi University of Chinese Medicine

Address：

Affiliated Hospital of Shaanxi University of Chinese Medicine, Qindu District, Xianyang City, Shaanxi Province

Source(s) of funding：

Shaanxi administration of traditional Chinese medicine

Target disease：

Sarcopenia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

The purpose of this study was to compare the effects of resistance training and acupuncture combined with resistance training on muscle function and systemic symptoms in patients with SP., we hope to find the direction in the treatment of SP with acupuncture and other therapies.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1 patients who meet the diagnostic criteria of sarcoidosis; 2 patients who were 60-80 years old and of either sex; 3 patients who agreed to participate in the study and signed the informed consent form.

Exclusion criteria：

1. A severe primary disease of the vital organs (such as the heart, kidneys, liver, etc.) or of the vital system. 2. People who have physical problems in their limbs (such as fractures, cerebral infarction, or intracerebral hemorrhage) or who have weight-related problems (such as long-term steroid use) . 3. The ADL score was less than 60 in those whose ADL was limited to some extent. 4. Implants of electronic devices or metal objects (such as artificial pacemaker or artificial joints) 5. Severe mental illness or cognitive impairment 6. Have underlying diseases (hypertension, diabetes, coronary heart disease, etc.) and the underlying diseases are not in a stable stage; 7. Patients with reduced muscle mass or strength due to other causes (myasthenia gravis, spinal cord injury, diabetes, COPD, etc.) were excluded. 8. Long-term bedridden patients caused by sequelae of stroke, spinal cord injury and limb disability were excluded. 9. Patients with other muscular diseases such as amyotrophic lateral sclerosis and muscular dystrophy were excluded.

Study execute time：

From 2024-08-07

To      2026-08-07

Recruiting time：

From 2024-08-07

To      2026-01-01

Interventions：

120

Group：

Sham acupuncture group

Sample size：

Intervention：

Sham acupuncture with Resistance training

Intervention code：

120

Group：

Acupuncture Group

Sample size：

Intervention：

Acupuncture with Resistance training

Intervention code：

Total sample size ： 240

Countries of recruitment
and research settings：

Country：

Chinese

Province：

Shaanxi Province

City：

Xianyang City

Institution/hospital：

陕西中医药大学附属医院

Level of the institution：

Grade A

Country：

Chinese

Province：

Shaanxi Province

City：

Xi'an City

Institution/hospital：

Xi’an Hospital of Traditional Chinese Medicine

Level of the institution：

Grade A

Country：

Chinese

Province：

Shaanxi Province

City：

Xi'an City

Institution/hospital：

Xi'an HongHui Hospital

Level of the institution：

Grade A

Outcomes：

Outcome：

Irisin

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

Laboratory examination

Outcome：

Blood routine test

Type：

Adverse events

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

Laboratory examination

Outcome：

Hip circumference

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 30 days 60 days 30 days after treatment 90 days after treatmen

Measure method：

Outcome：

Muscle grip strength of upper limbs

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, 30 days, 60 days, 30 days after treatment, 90 days after treatmen

Measure method：

Grip strength tester

Outcome：

ECG examination

Type：

Adverse events

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

12 lead ECG examination

Outcome：

Liver and kidney function

Type：

Adverse events

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

Laboratory examination

Outcome：

Appendicular skeletal muscle mass，ASMI

Type：

Primary indicator

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

Dual-energy X-ray absorption method，DAX

Outcome：

Waist circumference

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 30 days 60 days 30 days after treatment 90 days after treatmen

Measure method：

Outcome：

6m pace test

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, 30 days, 60 days, 30 days after treatment, 90 days after treatmen

Measure method：

The participants were asked to walk at their usual walking speed. During the test, the participants' toes touched the 0-meter mark line, and the time started from the first step of the 0-meter line, and ended at the first step of the 6-meter line, record the corresponding time in seconds. Test three times, each rest for 1 minute, take the minimum value as a test indicator.

Outcome：

Calf circumference

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 30 days 60 days 30 days after treatment 90 days after treatmen

Measure method：

Outcome：

Short physical performance battery，SPPB

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, 30 days, 60 days, 30 days after treatment, 90 days after treatmen

Measure method：

Scale scores

Outcome：

L3 level abdominal muscle density

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

QCT

Outcome：

Myostatin

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

Laboratory examination

Outcome：

five times sit to stand test，FTSST

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, 30 days, 60 days, 30 days after treatment, 90 days after treatmen

Measure method：

The subjects crossed their hands in front of their chests, stood up from a chair until their legs were fully extended and then sat down. The time required was calculated for 5 consecutive times, and the experiment was repeated 3 times.

Outcome：

Blood sugar

Type：

Adverse events

Measure time point of outcome：

Before treatment, 60 days and 90 days after treatment

Measure method：

Laboratory examination

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

60
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Wenxiong Li, who led the study, used a central randomization, complete randomization method and SPSS to generate 240 random triple digits. The three-digit number was recorded as a random number. The patients were numbered 001 -240 in the Order of admission, which was consistent with the random number Subsequently, 240 random numbers were sorted and numbered from small to large (the same data were numbered in sequence) , and designated as acupuncture group with serial numbers 001-120 and control group with serial numbers 121-240

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Please contact the corresponding author by e-mail if you need the original data after the experiment is completed and the paper is published

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form, CRF

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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