Effect of Triflow Breathing Training

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication; Haemolyses and Related Conditions
• Intervention / Treatment: Other: 8-week breath training program

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Long-term hemodialysis is required to treat patients with end-stage renal disease diagnosed by a physician.
2. Blood older than or equal to 65 years old and under 80 years old with diabetes Dialysis patients.
3. 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.
4. Those who are conscious and have no serious mental symptoms, can talk and express and agree to Subject to respirator training and questionnaires.
5. Available country and Taiwanese communicators.
6. The average score of the Situational Trait Anxiety Scale is greater than 20 points.

Exclusion Criteria:

1. Patients with low blood pressure during dialysis can not raise the bed to 30 degrees.
2. Blindness and hearing or long-term bedridden.
3. There are cases of irregular heartbeat.
4. The Daily Activity Scale is less than or equal to 60 points (the study uses the Barthel Index).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1 dialysis on Mondays, Wednesdays, and Fridays; 8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.	Other: 8-week breath training program; 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.
Other: Group 2 dialysis on Tuesdays, Thursdays, and Saturdays; 8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.	Other: 8-week breath training program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	The level of quality of life was measured at the first week, 4th week and the 8th week.

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Chii Jeng, PhD, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2020
• Primary Completion (Actual): May 14, 2021
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemolysis
• Other Study ID Numbers: N202001049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No