Clinical trial NCT05809765: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Haemolyses and Related Conditions
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
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.
timeFrame: 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.
measure: Changes of the level of anxiety
timeFrame: The level of anxiety was measured at the first week, 4th week and the 8th week.
measure: Changes of the level of quality of life
timeFrame: The level of quality of life was measured at the first week, 4th week and the 8th week.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Chii Jeng, PhD
role: PRINCIPAL_INVESTIGATOR
References: