Efficacy and mechanism of online Qigong intervention in type 2 diabetic peripheral neuropathy

Phase 1

Recruiting

• Conditions: diabetic peripheral neuropathy

• Registration Number: ITMCTR2100004823
• Lead Sponsor: Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. All potential patients will be assessed for trial eligibility by a clinician;
2. Have diagnostic type 2 diabetes with diabetic peripheral neuropathy:
(1) having a history of type 2 diabetesand and glycated haemoglobin control of less than 10% for the last 1 month;
(2) having diabetic peripheral neuropathy upon being or after being diagnosed with type 2 diabetes;
(3) in patients with clinical symptoms of neuropathy, diabetic peripheral neuropathy is diagnosed in >= 1 of the following 5 tests; in patients without clinical symptoms, diabetic peripheral neuropathy is diagnosed in >= 2 of the following 5 tests: A.abnormal temperature sensation; B.abnormal pressure sensation; C. abnormal vibration sensation; D. abnormal pinprick pain sensation (10g nylon wire examination, reduced or absent sensation in the foot); E. absent ankle reflex.
3. Aged 18 to 80 years;
4. Having an electronic device at home (e.g., a computer or mobile phone): can have access to online Qigong exercise program;
5. Willing and able to regularly attend online Qigong exercise for 3 times/week, 1-1.5 hours/session ;
6. Able to cooperate with requirement of study (including assessments, etc.);
7. Able to do Qigong exercise, and cooperate with the instructor of the online Qigong intervention program;
8. Will not participate in any other clinical trials during the study;
9. Will not practise any other Tai Chi or Qigong exercise during the study.

Exclusion Criteria

1. Other diseases diagnosed by clinicians, including cervical and lumbar disease (e.g., nerve root compression, stenosis, vertebral degeneration), cerebral infarction, Guillain-Barre syndrome, severe arteriovenous vascular diseases (e.g., venous thrombosis, lymphangitis); and peripheral neuropathy caused by drugs (especially chemotherapy)and renal insufficiency;
2. According to the recommendations of the American Academy of Sports Medicine in 2000, it is forbidden to participate in physical activities (e.g., unstable angina, uncontrolled blood pressure > 200/110 mmHg, orthostatic hypotension > 20 mmHg, critical aortic stenosis, uncontrolled atrial or ventricular arrythmia, uncontrolled sinus tachycardia, acute systemic illness or fever, moderate to severe heart failure, 3 degrees AV block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, resting ST segment displacement [>2mm]);
3. A diagnosis of dementia, malignant tumor or life-threatening disease;
4. History of bipolar disorder, schizophrenia and other severe mental diseases including major depressive disorder(except depression symptoms);
5. History of severe hypoglycemia;
6. Pregnant women, lactating women or those who plan to become pregnant in the next 6 months;
7. Practiced Tai Chi or Qigong in the past 3 months;
8. Addicts of alcohol and caffeine;
9. Have planned to move to another city or overseas in the coming 6 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toronto clinical scoring system;Nerve conduction velocity;Glycated hemoglobin;

Secondary Outcome Measures

Name	Time	Method
Height, weight, body mass index;TCM Symptom score;Depression Anxiety Stress Scale 21;Blood pressure;Insulin resistance;Timed up and go test;Single leg stance with eyes closed;Nerve growth factor;The 30-s Chair stand test;Hemorheology;Fasting insulin;the Physical Activity Enjoyment Scale;Fasting plasma glucose;Pittsburgh Sleep Index Scale;Serum cortisol;Inflammatory cytokines(interleukin-1ß, interleukin-6, interleukin-10, tumor necrosis factor alpha and C-reactive protein);the Short-Form 36 item health;Waist circumference;The Morse Risk Assessment Scale for Falls;Laser doppler flowmetry inspection;