Research on postoperative exercise program of lower extremity artery ischemic disease based on Internet +

Registration number:

ITMCTR2022000113

Date of Last Refreshed on:

2022-11-29

Date of Registration:

2022-06-29

Registration Status:

Prospective registration

Public title:

Research on postoperative exercise program of lower extremity artery ischemic disease based on Internet +

English Acronym:

Scientific title:

Research on postoperative exercise program of lower extremity artery ischemic disease based on Internet +

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200066174 ; ChiMCTR2200006827

Applicant:

XiaoMei Fang

Study leader:

Huanping Liu

Applicant telephone:

13661326274

Study leader's telephone:

13552789768

Applicant Fax:

Study leader's fax:

Applicant E-mail:

13661326274@163.com

Study leader's E-mail:

1470805033@qq.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

No.1, R. Xiyuangcaochang, District Haidian,Beijing,China

Study leader's address:

No.1, R. Xiyuangcaochang, District Haidian,Beijing,China

Applicant postcode:

100091

Study leader's postcode:

100091

Applicant's institution:

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

2022XLA078-2

Approved file of Ethical Committee:

View

Name of the ethic committee:

Medical Ethics Committee of Xiyuan Hospital ofChinese Academy of Traditional Chinese Medicine

Date of approved by ethic committee:

2022/6/2 0:00:00

Contact Name of the ethic committee:

XiaoQiang Jia

Contact Address of the ethic committee:

No.1, R. Xiyuangcaochang, District Haidian,Beijing,China

Contact phone of the ethic committee:

010-62835646

Contact email of the ethic committee:

Primary sponsor:

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine

Primary sponsor's address:

No.1, R. Xiyuangcaochang, District Haidian,Beijing,China

Secondary sponsor:

Country:

China

Province:

Beijing

City:

Institution
hospital:

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine

Address:

No.1, R. Xiyuangcaochang, District Haidian,Beijing,China

Source(s) of funding:

Xiyuan Hospital ofChinese Academy of Traditional Chinese Medicine

Target disease:

chronic limb-threatening ischemia

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Pilot clinical trial

Objectives of Study:

1. To construct a post-interventional exercise management plan for patients with chronic lower extremity severe ischemia by combining a mobile application with continuation care of the disease. 2. To explore the improvement of limb blood supply after revascularization surgery for end-stage peripheral arterial disease in traditional Chinese medicine health-preserving exercise sitting Baduanjin by a randomized controlled study. To improve the quality of chronic disease management based on traditional Chinese medicine characteristics of continuous nursing.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1.Meet chronic limb‐threatening ischemiadiagnostic criteria 2.The wound area is 5-10cm2, not exceeding 20% of the full foot area. 3.Men and women are aged 18 to 75 years. 4.Volunteer subjects and signed the informed consent form.

Exclusion criteria:

1. Patients with Venous ulcers, pure trauma wounds, acute limb ischemia (symptoms persisting for 2 weeks or less), embolic disease, and non-atherosclerotic chronic vascular conditions of the lower extremities (eg, vasculitis, Buerger disease, radiation arteritis). 2. Patients under the age of 18 and over the age of 75. 3. The wound area exceeds 20% of the full foot area. 4. Patients who failed to open the target lesion vessel according to the Angiosome theory. 5. Patients with serious primary diseases such as heart, cerebrovascular, liver, kidney, hematopoietic system and endocrine system. 6. Patients with hearing, visual impairment, communication impairment and mental illness.

Study execute time:

From 2021-10-01

To      2024-10-01

Recruiting time:

From 2022-12-01

To      2024-03-01

Interventions:

70

Group:

experimental group

Sample size:

Intervention:

Ba Duan Jin Sitting

Intervention code:

70

Group:

control group

Sample size:

Intervention:

Ankle pump movement

Intervention code:

Total sample size : 140

Countries of recruitment
and research settings:

Country:

China

Province:

Beijing

City:

Institution/hospital:

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine

Level of the institution:

Grade A tertiary hospital

Country:

China

Province:

Beijing

City:

Institution/hospital:

Guang'an Gate HospitalofChinese Academy of Traditional Chinese Medicine

Level of the institution:

Grade A tertiary hospital

Country:

China

Province:

Beijing

City:

Institution/hospital:

WangjingHospitalof Chinese Academy of Traditional Chinese Medicine

Level of the institution:

Grade A tertiary hospital

Outcomes:

Outcome:

Pain score

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Walking energy

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

ankle brachial index

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Quality of life measurement

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Psychological situation

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

without

Tissue:

Fate of sample 

Destruction after use

Note:

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

a simple random method to generate random sequences by the research nurse.

Blinding:

IPD sharing:

No

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

Not stated

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above