Dialysis; ComplicationsNCT06412770
Effect of Tai Chi on Symptoms in Hemodialysis Patients
A study testing Tai chi, Tai Chi imagery and no-intervention in people with Dialysis; Complications and Chinese Medicine, run by Chengdu University of Traditional Chinese Medicine.
Trial summary
The goal of this clinical trial is to learn about the effect of Tai Chi on symptoms in hemodialysis patients.The main question[s] it aims to answer are: the effect of Tai Chi on symptoms or the quality of life in hemodialysis patients .Participants will be divided into three groups, one group will be asked to do Tai… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis; Complications, Chinese Medicine, Quality of Life
- What is being tested?
- Tai chi, Tai Chi imagery and no-intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18;
- Dialysis age≥ 3 months;
- Survival≥ 12 months;
- The patient has the ability to move independently, can learn independently, and has no reading and comprehension disabilities;
- Informed consent
Who cannot join
- Inability to move autonomously;
- Have a mental disorder;
- Other serious complications occur
About this study
Official title: Director, World Health Organization (WHO)
The goal of this clinical trial is to learn about the effect of Tai Chi on symptoms in hemodialysis patients.The main question[s] it aims to answer are: the effect of Tai Chi on symptoms or the quality of life in hemodialysis patients .Participants will be divided into three groups, one group will be asked to do Tai Chi for 30 minutes three times a week, and the other group will be asked to do Tai Chi imagery for 30 minutes three times a week. The comparison group will be given usual care. Researchers will compare the efficacy of symptoms and quality of life in dialysis patients in each group.
- Conditions
- Dialysis; Complications, Chinese Medicine, Quality of Life
- Being tested
- Tai chi, Tai Chi imagery, no-intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai chiBehavioural
Participants will be asked to do Tai Chi for 30 minutes three times a week
Tai Chi imageryBehavioural
Participants will be asked to do Tai Chi imagery for 30 minutes three times a week
no-interventionOther
The comparison group will be given usual care
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi intervention group | Experimental | Tai Chi intervention group Receives: Behavioral: Tai chi |
| Tai Chi Imagery Intervention Group | Placebo comparator | Tai Chi Imagery Intervention Group Receives: Behavioral: Tai Chi imagery |
| Control group | Other | no intervention Receives: Other: no-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of life quality after treatment
The effects of tai Chi on symptoms (fatigue, pain, depression, sleep) of hemodialysis patients were assessed by scale
Measured: Assessment was performed at 4, 8, and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis; ComplicationsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, qinxiu zhang, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412770
- Sponsor's protocol ID
- chengduTCM20240314
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director, World Health Organization (WHO)
- ClinicalTrials.gov ID
- NCT06412770
- Acronym / sponsor ID
- chengduTCM20240314
- Conditions
- Dialysis; Complications, Chinese Medicine, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 May 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.
The goal of this clinical trial is to learn about the effect of Tai Chi on symptoms in hemodialysis patients.The main question[s] it aims to answer are: the effect of Tai Chi on symptoms or the quality of life in hemodialysis patients .Participants will be divided into three groups, one group will be asked to do Tai Chi for 30 minutes three times a week, and the other group will be asked to do Tai Chi imagery for 30 minutes three times a week. The comparison group will be given usual care. Researchers will compare the efficacy of symptoms and quality of life in dialysis patients in each group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai Chi intervention group | Experimental | Behavioral: Tai chiTai Chi intervention group |
| Tai Chi Imagery Intervention Group | Placebo comparator | Behavioral: Tai Chi imageryTai Chi Imagery Intervention Group |
| Control group | Other | Other: no-interventionno intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥ 18;
- Dialysis age≥ 3 months;
- Survival≥ 12 months;
- The patient has the ability to move independently, can learn independently, and has no reading and comprehension disabilities;
- Informed consent
Key exclusion criteria (3 listed)
- Inability to move autonomously;
- Have a mental disorder;
- Other serious complications occur
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 |
|---|---|---|
| Tai chiParticipants will be asked to do Tai Chi for 30 minutes three times a week | Behavioural | Tai Chi intervention group |
| Tai Chi imageryParticipants will be asked to do Tai Chi imagery for 30 minutes three times a week | Behavioural | Tai Chi Imagery Intervention Group |
| no-interventionThe comparison group will be given usual care | Other | Control group |
Primary outcome
Evaluation of life quality after treatment
Time frame: Assessment was performed at 4, 8, and 12 weeks after treatment
The effects of tai Chi on symptoms (fatigue, pain, depression, sleep) of hemodialysis patients were assessed by scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tai chi, Tai Chi imagery and no-intervention in people with Dialysis; Complications and Chinese Medicine, run by Chengdu University of Traditional Chinese Medicine.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Evaluation of life quality after treatment (time frame: Assessment was performed at 4, 8, and 12 weeks after treatment). 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 14 May 2024.