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

NCT06245850 | Completed DMC

• 2 other identifiers: Zhengzhouuniversity82071331
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients and their families all agreed .

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Baduanjin Group

EXPERIMENTAL

Behavioral: Baduanjin

REBTgroup

ACTIVE COMPARATOR

Behavioral: Rational emotive behavior therapy

Interventions

Baduanjin BEHAVIORAL

chinese baduanjin

Baduanjin Group

Rational emotive behavior therapy BEHAVIORAL

Rational emotive behavior therapy

REBTgroup

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The course of stroke was 2 weeks to 6 months, with steady conditions and stable vital signs.
• The age ranged from 30 to 80 years old, with at least a junior high school education.
• The patients had no serious intellectual, language comprehension and behavioral disorders, and could complete the assessment of scales.
• Achieving a sitting balance of at least reaches level 3, Brunnstrom stage IV or above, and being able to complete Baduanjin training.
• The National Institutes of Health Stroke Scale (NIHSS) ≤ 15 points.
• Conforming to the diagnostic criteria for depression in the \"Chinese Experts Consensus on Clinical Practice of Post-Stroke Depression\".

You may not qualify if:

• Disturbance of consciousness, unable to cooperate with polysomnography (PSG) and scale evaluators.
• Pre-existing diagnosis of depression before stroke.
• Severe pre-existing sleep disorders before stroke.
• Patients with mental illness, immune system disorders, severe liver and kidney dysfunction, and severe cardiopulmonary dysfunction

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Henan

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: June 20, 2021
• Primary Completion: July 25, 2022
• Study Completion: February 10, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)