Back to resultsEffect of Triflow Breathing Training
Primary Purpose
Hemodialysis Complication, Haemolyses and Related Conditions
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
8-week breath training program
Sponsored by
About this trial
This is an interventional prevention trial for Hemodialysis Complication
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1 dialysis on Mondays, Wednesdays, and Fridays
Group 2 dialysis on Tuesdays, Thursdays, and Saturdays
Arm Description
8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.
8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05809765
First Posted
March 9, 2023
Last Updated
April 11, 2023
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05809765
Brief Title
Effect of Triflow Breathing Training
Official Title
Effect of Triflow Breathing Training on Heart Rate Variability, Anxiety and Quality of Life in Hemodialysis Patients : A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 16, 2020 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication, Haemolyses and Related Conditions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 dialysis on Mondays, Wednesdays, and Fridays
Arm Type
Other
Arm Description
8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.
Arm Title
Group 2 dialysis on Tuesdays, Thursdays, and Saturdays
Arm Type
Other
Arm Description
8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.
Intervention Type
Other
Intervention Name(s)
8-week breath training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
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.
Title
Changes of the level of anxiety
Description
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.
Time Frame
The level of anxiety was measured at the first week, 4th week and the 8th week.
Title
Changes of the level of quality of life
Description
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.
Time Frame
The level of quality of life was measured at the first week, 4th week and the 8th week.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chii Jeng, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Triflow Breathing Training
We'll reach out to this number within 24 hrs