Tai Chi for Comorbid Depression in T2DM Patients

NCT ID: NCT04609631

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression T2DM

Keywords

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Tai Chi Depression T2DM Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tai Chi (5 times/week)

5 sessions of Tai Chi per week for 12 weeks

Group Type EXPERIMENTAL

Tai Chi

Intervention Type BEHAVIORAL

24-form Tai Chi will be performed for 12 weeks. Each session contains a warm-up period (10 minutes), a Tai Chi period (40 minutes) and a cool-down period (10 minutes).

Tai Chi (3 times/week)

3 sessions of Tai Chi per week for 12 weeks

Group Type EXPERIMENTAL

Tai Chi

Intervention Type BEHAVIORAL

24-form Tai Chi will be performed for 12 weeks. Each session contains a warm-up period (10 minutes), a Tai Chi period (40 minutes) and a cool-down period (10 minutes).

Tai Chi (1 time/week)

1 session of Tai Chi per week for 12 weeks

Group Type EXPERIMENTAL

Tai Chi

Intervention Type BEHAVIORAL

24-form Tai Chi will be performed for 12 weeks. Each session contains a warm-up period (10 minutes), a Tai Chi period (40 minutes) and a cool-down period (10 minutes).

cognitive behavior therapy (CBT)

1 session of CBT per week for 12 weeks

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.

Waiting-list

Participants will maintain their routine treatment and life style for 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tai Chi

24-form Tai Chi will be performed for 12 weeks. Each session contains a warm-up period (10 minutes), a Tai Chi period (40 minutes) and a cool-down period (10 minutes).

Intervention Type BEHAVIORAL

CBT

CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Di Qin

Chengdu University of Traditional Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youping Liu, PhD

Role: STUDY_CHAIR

Chengdu University of Traditional Chinese Medicine

Locations

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Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Site Status

Henan University of Chinese Medicine

Zhengzhou, Henan, China

Site Status

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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2019YFC1710302

Identifier Type: -

Identifier Source: org_study_id