Effect of Triflow Breathing Training

NCT ID: NCT05809765

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-16
• Study Completion Date: 2021-05-14

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.

Conditions

Hemodialysis Complication; Haemolyses and Related Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1 dialysis on Mondays, Wednesdays, and Fridays

8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.

Group Type: OTHER

8-week breath training program

Intervention Type: OTHER

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.

Group 2 dialysis on Tuesdays, Thursdays, and Saturdays

8-week breath training by using a disposable, flow-oriented, Triflow three-ball incentive spirometer.

Group Type: OTHER

8-week breath training program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chii Jeng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chii Jeng, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202001049

Identifier Type: -

Identifier Source: org_study_id