StrokeZZUNCT06245850
Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression
A study testing Baduanjin and Rational emotive behavior therapy in people with Stroke, run by Zhengzhou University at 1 site in China.
Trial summary
Patients and their families all agreed . Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Baduanjin and Rational emotive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2021to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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\".
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Patients and their families all agreed .
- Conditions
- Stroke
- Being tested
- Baduanjin, Rational emotive behavior therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaduanjinBehavioural
chinese baduanjin
Rational emotive behavior therapyBehavioural
Rational emotive behavior therapy
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin Group | Experimental | Not described Receives: Behavioral: Baduanjin |
| REBTgroup | Active comparator | Not described Receives: Behavioral: Rational emotive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start20 Jun 2021
- Primary completion25 Jul 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yihan, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245850
- Sponsor's protocol ID
- Zhengzhouuniversity
- Other IDs
- 82071331
- Acronym
- ZZU
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06245850
- Acronym / sponsor ID
- ZZU / Zhengzhouuniversity
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients and their families all agreed .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin Group | Experimental | Behavioral: Baduanjin |
| REBTgroup | Active comparator | Behavioral: Rational emotive behavior therapy |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjinchinese baduanjin | Behavioural | Baduanjin Group |
| Rational emotive behavior therapyRational emotive behavior therapy | Behavioural | REBTgroup |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin and Rational emotive behavior therapy in people with Stroke, run by Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.