Impact of Baduanjin Exercise Combined With Rational Emoti... | NCT06245850

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

NCT06245850

Sponsor

Zhengzhou University

Status

Completed

Last Update Posted

Feb 9, 2024Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

Baduanjin
Rational emotive behavior therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
82071331	Other Grant/Funding Number	National Natural Science fouding

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2021Actual

Primary Completion Date

Jul 25, 2022Actual

Completion Date

Feb 10, 2023Actual

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Feb 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baduanjin Group	Experimental		Behavioral: Baduanjin
REBTgroup	Active Comparator		Behavioral: Rational emotive behavior therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baduanjin	Behavioral	chinese baduanjin	Baduanjin Group
Rational emotive behavior therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Henan		Zhengzhou	Henan	450000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases