Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients

Breathing exercises to improve fatigue and quality of life in hemodialysis patients

Study Overview

• Status: Completed
• Conditions: Fatigue; Hemodialysis; Breathing Exercises
• Intervention / Treatment: Other: Breathing exercises

Detailed Description

Patients receiving haemodialysis have poor physical function, psychological status and quality of life than the general population.Fatigue is a debilitating symptom in haemodialysis patients Exercise training may improve these parameters for haemodialysis patients.

A 3-month randomized control trial with baseline、Week 4、Week 12 measurement periods was conducted. Exercise group was taught to Breathing exercise week and Usual care for three months. The control group received usual routine care.

A total of 86 patients participated in this study, with 43 patients in the Exercise group and 43 patients in the control group Methods: Hemodialysis Fatigue scale 、 WHOQOL-BREF 、 HADS_ Anxiety

、 HRV

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county, Taiwan, 220
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. diagnosed by end-stage renal disease, regular hemodialysis three times a week and up to six months or more
2. Adults over 20 years of age.
3. Consciousness.
4. can be used to communicate in Taiwanese, accept questionnaire interviews or self-filling questionnaire.
5. no chest pain or shortness of breath symptoms.
6. No lower extremity disability and ability to walk on their own.
7. agree to take respiratory exercise intervention measures, have the intention to participate in this study and signed a consent form.

Exclusion Criteria:

1. unstable vital signs, or serious heart disease: such as the diagnosis of myocardial infarction, unstable angina pectoris, cardiopulmonary disease and other patients.
2. A complication occurs, such as aspiration pneumonia.
3. history of arrhythmia, as well as taking heart rate medication.
4. Physician's advice is not suitable for exercise, such as bone and joint problems.
5. There is a temporary double vena cava catheter placed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group; Hemodialysis patients in the control group who receive only routine nursing care during hemodialysis
EXPERIMENTAL: exercise group; The exercise group are asked to perform breathing exercises during hemodialysis for the study period of 3 months.	Other: Breathing exercises; During hemodialysis, the participants in the exercise group are asked to keep ttheir muscles relaxed, breathe normally through the nose at a rate of 3-8 times per minute with each breath held over 5 seconds in length. At the same time, the particpants are asked to also perform lower leg lifts for about 8 seconds per lift. The exercise is performed for 15-20 minutes, and after resting, blood pressure, oxygen saturation and HRV are measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fatigue	Assessment of fatigue using fatigue score with a lowest score of 26 points and highest score of 104 points in the control group and the exercise group at the start of the study(baseline), Week 4 and Week 12 for a total of A 3-month	A 3-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	Assessment of quality of life score using WHOQOL-BREF with a lowest score of 26 points and highest score of 130 points in the control group and the exercise group at the start of the study (baseline), Week 4 and Week 12 for a total of A 3-month	A 3-month

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): June 15, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: April 8, 2018
• First Posted (ACTUAL): April 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: fatigue; quality of life; Breathing exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Fatigue; Respiratory Aspiration
• Other Study ID Numbers: 4rfvgy7m

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