Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression

Stroke Clinical Trial

— ZZU  

Official title:

Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06245850
• Other study ID #: Zhengzhouuniversity
• Secondary ID: 82071331
• Status: Completed
• Phase: N/A
• Start date: June 20, 2021
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2024
• Source: Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients and their families all agreed .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 10, 2023
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. Conformity to the diagnostic criteria for stroke in the "Diagnostic Essentials of Various Cerebrovascular Diseases" revised by the Fourth National Cerebrovascular Academic Conference, and confirmed by cranial CT or MRI.

2. The course of stroke was 2 weeks to 6 months, with steady conditions and stable vital signs.

3. The age ranged from 30 to 80 years old, with at least a junior high school education.

4. The patients had no serious intellectual, language comprehension and behavioral disorders, and could complete the assessment of scales.

5. Achieving a sitting balance of at least reaches level 3, Brunnstrom stage IV or above, and being able to complete Baduanjin training.

6. The National Institutes of Health Stroke Scale (NIHSS) = 15 points.

7. Conforming to the diagnostic criteria for depression in the "Chinese Experts Consensus on Clinical Practice of Post-Stroke Depression".

Exclusion Criteria:

The exclusion criteria:

1. Disturbance of consciousness, unable to cooperate with polysomnography (PSG) and scale evaluators.

2. Pre-existing diagnosis of depression before stroke.

3. Severe pre-existing sleep disorders before stroke.

4. Patients with mental illness, immune system disorders, severe liver and kidney dysfunction, and severe cardiopulmonary dysfunction

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Baduanjin
chinese baduanjin
• Rational emotive behavior therapy
Rational emotive behavior therapy

Locations

Country	Name	City	State
China	Henan	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD score	HAMD score: The Hamilton Depression Scale (HAMD) were used to evaluate the depression level of the subjects. The HAMD-17 score is 0-6 points for no depression, 8 7-17 points for mild depression, 18-24 points for moderate depression, and 25-54 points for severe depression. A higher score corresponds to more severe depression.	8 weeks