Back to resultsBreathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
Primary Purpose
Hemodialysis, Breathing Exercises, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Breathing exercises
Sponsored by
About this trial
This is an interventional supportive care trial for Hemodialysis focused on measuring Breathing exercises, fatigue, quality of life
Eligibility Criteria
Inclusion Criteria:
- diagnosed by end-stage renal disease, regular hemodialysis three times a week and up to six months or more
- Adults over 20 years of age.
- Consciousness.
- can be used to communicate in Taiwanese, accept questionnaire interviews or self-filling questionnaire.
- no chest pain or shortness of breath symptoms.
- No lower extremity disability and ability to walk on their own.
- agree to take respiratory exercise intervention measures, have the intention to participate in this study and signed a consent form.
Exclusion Criteria:
- unstable vital signs, or serious heart disease: such as the diagnosis of myocardial infarction, unstable angina pectoris, cardiopulmonary disease and other patients.
- A complication occurs, such as aspiration pneumonia.
- history of arrhythmia, as well as taking heart rate medication.
- Physician's advice is not suitable for exercise, such as bone and joint problems.
- There is a temporary double vena cava catheter placed.
Sites / Locations
- Far Eastern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
exercise group
Arm Description
Hemodialysis patients in the control group who receive only routine nursing care during hemodialysis
The exercise group are asked to perform breathing exercises during hemodialysis for the study period of 3 months.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03499054
First Posted
January 31, 2018
Last Updated
April 8, 2018
Sponsor
National Taipei University of Nursing and Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03499054
Brief Title
Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
Official Title
Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Breathing exercises to improve fatigue and quality of life in hemodialysis patients
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Breathing Exercises, Fatigue
Keywords
Breathing exercises, fatigue, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized hemodialysis patients in hospital
Masking
Investigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Hemodialysis patients in the control group who receive only routine nursing care during hemodialysis
Arm Title
exercise group
Arm Type
Experimental
Arm Description
The exercise group are asked to perform breathing exercises during hemodialysis for the study period of 3 months.
Intervention Type
Other
Intervention Name(s)
Breathing exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
fatigue
Description
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
Time Frame
A 3-month
Secondary Outcome Measure Information:
Title
quality of life
Description
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
Time Frame
A 3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed by end-stage renal disease, regular hemodialysis three times a week and up to six months or more
Adults over 20 years of age.
Consciousness.
can be used to communicate in Taiwanese, accept questionnaire interviews or self-filling questionnaire.
no chest pain or shortness of breath symptoms.
No lower extremity disability and ability to walk on their own.
agree to take respiratory exercise intervention measures, have the intention to participate in this study and signed a consent form.
Exclusion Criteria:
unstable vital signs, or serious heart disease: such as the diagnosis of myocardial infarction, unstable angina pectoris, cardiopulmonary disease and other patients.
A complication occurs, such as aspiration pneumonia.
history of arrhythmia, as well as taking heart rate medication.
Physician's advice is not suitable for exercise, such as bone and joint problems.
There is a temporary double vena cava catheter placed.
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei county
ZIP/Postal Code
220
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
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