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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Rational emotive behavior therapy; Behavioral: Baduanjin

• Registration Number: NCT06245850
• Lead Sponsor: Zhengzhou University

Brief Summary

Patients and their families all agreed .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-20
• Primary Completion: 2022-07-25
• Study Completion: 2023-02-10
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REBTgroup	Rational emotive behavior therapy	-
Baduanjin Group	Baduanjin	-

Primary Outcome Measures

Name	Time	Method
HAMD score	8 weeks	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.

Trial Locations

Locations (1)

Henan; 🇨🇳 Zhengzhou, Henan, China