Hemodialysis ComplicationNCT05809765
Effect of Triflow Breathing Training
A study testing 8-week breath training program in people with Hemodialysis Complication and Haemolyses and Related Conditions, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
This study aims to explore whether an 8-week Triflow breath training program reduced the anxiety levels and improved the heart rate variability and quality of life of patients receiving hemodialysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodialysis Complication, Haemolyses and Related Conditions
- What is being tested?
- 8-week breath training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 May 2020to 14 May 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Long-term hemodialysis is required to treat patients with end-stage renal disease diagnosed by a physician.
- Blood older than or equal to 65 years old and under 80 years old with diabetes Dialysis patients.
- Hemodialysis has been accepted for more than three months and is still under treatment and half There were no hospitalizations for other comorbidities during the year.
- Those who are conscious and have no serious mental symptoms, can talk and express and agree to Subject to respirator training and questionnaires.
- Available country and Taiwanese communicators.
- The average score of the Situational Trait Anxiety Scale is greater than 20 points.
Who cannot join
- Patients with low blood pressure during dialysis can not raise the bed to 30 degrees.
- Blindness and hearing or long-term bedridden.
- There are cases of irregular heartbeat.
- The Daily Activity Scale is less than or equal to 60 points (the study uses the Barthel Index).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Triflow Breathing Training on Heart Rate Variability, Anxiety and Quality of Life in Hemodialysis Patients : A Randomized Control Trial
This study aims to explore whether an 8-week Triflow breath training program reduced the anxiety levels and improved the heart rate variability and quality of life of patients receiving hemodialysis. To investigate the effect of the triflow respiration training on the improvement of heart rate variability, anxiety, and the quality of life in hemodialysis patients.
Read the detailed description
Method:This research adapted the cluster randomization design. The participants were divided into the first group of patients undergoing hemodialysis every Monday, Wednesday, and Friday and the second group undergoing dialysis every Tuesday, Thursday, and Saturday. The experimental group and the control group were randomly assigned by a coin toss. The investigators conducted the study for eight weeks and investigated the effects of respiration training on the improvement of heart rate variability, anxiety, and quality of life in hemodialysis patients. Patients in the experimental group receive the triaflow respiration training three times a week for eight weeks during hemodialysis. Data were collected by a heart rate variability monitor, State-Trait Anxiety Inventory and WHOQOL-BREF at baseline and after a 8-week respiration training.
- Being tested
- 8-week breath training program
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week breath training programOther
The participants were asked to be seated comfortably and raise their heads by 30° with the guidance of the investigator. During the inspiration process, the participants' abdomens bulged. They then held their breaths for 5 seconds before exhaling from their mouths for twice the duration of inspiration. Breath training was performed five times each hour throughout the three-hour duration of each dialysis session. In sum, the experimental group performed Triflow breath training 15 times during each dialysis session. The experimental group and the control group were randomly assigned by a coin toss.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 dialysis on Mondays, Wednesdays, and Fridays | Other | 8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer. Receives: Other: 8-week breath training program |
| Group 2 dialysis on Tuesdays, Thursdays, and Saturdays | Other | 8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer. Receives: Other: 8-week breath training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of heart rate variability, the measurement indices were the total power, which reflects the autonomic tone; the low-frequency component of heart rate variability.
The heart rate variability was measured using the 60601-1 program provided by Daily Care BioMedical, and the balance of their autonomic nervous systems was analyzed using the 60601-1 software.
Measured: For the experimental group, heart rate variability was measured each week during the 8-week breath training. For the control group, heart rate variability was measured at the first, 4th and the 8th week.
Changes of the level of anxiety
The State-Trait Anxiety Inventory (STAI) is used to measure the levels of anxiety. It consists of two subscales: one for state anxiety and the other for trait anxiety. Each subscale comprises 20 items, rated using a 4-point Likert scale (1 = hardly; 2 = sometimes; 3 = often; and 4 = almost always), with a total score of 20-80.
Measured: The level of anxiety was measured at the first week, 4th week and the 8th week.
Changes of the level of quality of life
The Chinese version of World Health Organization Quality of Life Brief Edition (WHOQoL-BREF) was used, which consists of 28 items. All items are rated using a 5-point Likert scale. Each Quality of life dimension differs in the number of items, and its score is determined by multiplying the mean score of all its items by 4. The average score of each dimension ranges from 4 to 20, with a higher score indicating a better Quality of life.
Measured: The level of quality of life was measured at the first week, 4th week and the 8th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start16 May 2020
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were divided into the first group of patients undergoing hemodialysis every Monday, Wednesday, and Friday and the second group undergoing dialysis every Tuesday, Thursday, and Saturday. The experimental group and the control group were randomly assigned by a coin toss. The investigators conducted the study for eight weeks and investigated the effects of respiration training on the improvement of heart rate variability, anxiety, and quality of life in hemodialysis patients.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chii Jeng, Taipei Medical University WanFang Hospital
- Investigators
- Chii Jeng, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809765
- Sponsor's protocol ID
- N202001049
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Triflow Breathing Training on Heart Rate Variability, Anxiety and Quality of Life in Hemodialysis Patients : A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05809765
- Acronym / sponsor ID
- N202001049
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 16 May 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 12 Apr 2023 (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.
This study aims to explore whether an 8-week Triflow breath training program reduced the anxiety levels and improved the heart rate variability and quality of life of patients receiving hemodialysis. To investigate the effect of the triflow respiration training on the improvement of heart rate variability, anxiety, and the quality of life in hemodialysis patients.
Detailed description
Method:This research adapted the cluster randomization design. The participants were divided into the first group of patients undergoing hemodialysis every Monday, Wednesday, and Friday and the second group undergoing dialysis every Tuesday, Thursday, and Saturday. The experimental group and the control group were randomly assigned by a coin toss. The investigators conducted the study for eight weeks and investigated the effects of respiration training on the improvement of heart rate variability, anxiety, and quality of life in hemodialysis patients. Patients in the experimental group receive the triaflow respiration training three times a week for eight weeks during hemodialysis. Data were collected by a heart rate variability monitor, State-Trait Anxiety Inventory and WHOQOL-BREF at baseline and after a 8-week respiration training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were divided into the first group of patients undergoing hemodialysis every Monday, Wednesday, and Friday and the second group undergoing dialysis every Tuesday, Thursday, and Saturday. The experimental group and the control group were randomly assigned by a coin toss. The investigators conducted the study for eight weeks and investigated the effects of respiration training on the improvement of heart rate variability, anxiety, and quality of life in hemodialysis patients.
| Arm | Type | Receives |
|---|---|---|
| Group 1 dialysis on Mondays, Wednesdays, and Fridays | Other | Other: 8-week breath training program8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer. |
| Group 2 dialysis on Tuesdays, Thursdays, and Saturdays | Other | Other: 8-week breath training program8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Long-term hemodialysis is required to treat patients with end-stage renal disease diagnosed by a physician.
- Blood older than or equal to 65 years old and under 80 years old with diabetes Dialysis patients.
- Hemodialysis has been accepted for more than three months and is still under treatment and half There were no hospitalizations for other comorbidities during the year.
- Those who are conscious and have no serious mental symptoms, can talk and express and agree to Subject to respirator training and questionnaires.
- Available country and Taiwanese communicators.
Key exclusion criteria (4 listed)
- Patients with low blood pressure during dialysis can not raise the bed to 30 degrees.
- Blindness and hearing or long-term bedridden.
- There are cases of irregular heartbeat.
- The Daily Activity Scale is less than or equal to 60 points (the study uses the Barthel Index).
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 |
|---|---|---|
| 8-week breath training programThe participants were asked to be seated comfortably and raise their heads by 30° with the guidance of the investigator. During the inspiration process, the participants' abdomens bulged. They then held their breaths for 5 seconds before exhaling from their mouths for twice the duration of inspiration. Breath training was performed five times each hour throughout the three-hour duration of each dialysis session. In sum, the experimental group performed Triflow breath training 15 times during each dialysis session. The experimental group and the control group were randomly assigned by a coin toss. | Other | Group 1 dialysis on Mondays, Wednesdays, and Fridays, Group 2 dialysis on Tuesdays, Thursdays, and Saturdays |
Primary outcome
Changes of heart rate variability, the measurement indices were the total power, which reflects the autonomic tone; the low-frequency component of heart rate variability.
Time frame: For the experimental group, heart rate variability was measured each week during the 8-week breath training. For the control group, heart rate variability was measured at the first, 4th and the 8th week.
The heart rate variability was measured using the 60601-1 program provided by Daily Care BioMedical, and the balance of their autonomic nervous systems was analyzed using the 60601-1 software.
Changes of the level of anxiety
Time frame: The level of anxiety was measured at the first week, 4th week and the 8th week.
The State-Trait Anxiety Inventory (STAI) is used to measure the levels of anxiety. It consists of two subscales: one for state anxiety and the other for trait anxiety. Each subscale comprises 20 items, rated using a 4-point Likert scale (1 = hardly; 2 = sometimes; 3 = often; and 4 = almost always), with a total score of 20-80.
Changes of the level of quality of life
Time frame: The level of quality of life was measured at the first week, 4th week and the 8th week.
The Chinese version of World Health Organization Quality of Life Brief Edition (WHOQoL-BREF) was used, which consists of 28 items. All items are rated using a 5-point Likert scale. Each Quality of life dimension differs in the number of items, and its score is determined by multiplying the mean score of all its items by 4. The average score of each dimension ranges from 4 to 20, with a higher score indicating a better Quality of life.
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 12 Apr 2023.
- 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.
Chii Jeng, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week breath training program in people with Hemodialysis Complication and Haemolyses and Related Conditions, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 6 inclusion and 4 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 12 Apr 2023. 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 Taiwan. 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?
Changes of heart rate variability, the measurement indices were the total power, which reflects the autonomic tone; the low-frequency component of heart rate variability. (time frame: For the experimental group, heart rate variability was measured each week during the 8-week breath training. For the control group, heart rate variability was measured at the first, 4th and the 8th week.). The study lists 3 primary outcomes in all. 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 12 Apr 2023.