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Completed

NCT Number: NCT06245850

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

Patients and their families all agreed .

Completed

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan

Zhengzhou, Henan, 450000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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".

Exclusion criteria

The exclusion criteria:

  • 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

Treatment and study plan

Baduanjin

Behavioral

chinese baduanjin

Rational emotive behavior therapy

Behavioral

Rational emotive behavior therapy

Primary outcomes

  1. HAMD score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Registry information

Official study 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

Acronym: ZZU

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 7, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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