Clinical trial NCT04609631: Tai Chi for Comorbid Depression in T2DM Patients
Official title: Tai Chi for Comorbid Depression in T2DM Patients: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
T2DM
Keywords: Tai Chi
Depression
T2DM
Randomized Controlled Trial
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: University of Electronic Science and Technology of China
First posted: 2020-10-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies suggested that Tai Chi may be beneficial for T2DM patients. However, no studies have investigated the effectiveness of Tai Chi for comorbid depression in T2DM patients, as well as the optimal frequency of Tai Chi. Thus, we intend to investigate the effectiveness of Tai Chi for comorbid depression in T2DM patients and test whether the effectiveness of Tai Chi depends on its frequency.


Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with depression by experienced psychiatrist;
* Participants diagnosed with T2DM by experienced endocrinologist;
* Participants aged between 18\~75 years;
* Participants with HbA1c ranges from 6.5% to 8.5%;
* Participants with Hamilton Depression Scale (HAMD) (24-item-version) ranges from 20\~35 scores;
* Participants passed the Physical Activity Readiness Questionnaire (PAR-Q);
* Participants willing to complete 12-week intervention and 12-week follow-up.
* Participants willing to sign informed consent form.

Exclusion Criteria:

* Participants with uncontrolled hypertension (SBP \>160mmHg or DBP \>100mmHg after taking hypotensive drugs);
* Participants with severe diabetic complications;
* Regular exercisers (at least 20 minutes/time, 3 times/week) in the last 3 months;
* Participants with cognitive impairment (Montreal Cognitive Assessment \[MoCA\] scores \<26);
* Participants with history of bipolar disorder or schizophrenia or other mental illness;
* Participants with contraindications to exercise;
* Participants with acute, infectious diseases, cancer, or serious neurological disease, cardiovascular disease, pulmonary disease or other serious medical conditions limiting the ability;
* Participants taking psychoactive drugs;
* Participants participating in other clinical trials at the same time.

Primary outcomes:
measure: Montgomery Asberg depression rating scale
timeFrame: change from baseline to 12 weeks after intervention
Secondary outcomes:
measure: Montgomery Asberg depression rating scale
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: Hamilton Depression Scale (HAMD) (24-item-version)
timeFrame: change from baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: Social Disability Screening Schedule
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: EuroQol-5D questionnaire
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: Clinical Global Impression scale
timeFrame: after intervention (12 weeks), after follow-up (24 weeks)
measure: Biochemical indicators
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: Fasting plasma glucose
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: Postprandial plasma glucose
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: insulin level
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Other outcomes:
measure: Pittsburgh sleep quality index
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
measure: Hamilton Anxiety Rating Scale
timeFrame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Locations:
city: Harbin
country: China
facility: Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan University of Chinese Medicine
state: Henan
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Youping Liu, PhD
role: STUDY_CHAIR
References: