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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499054
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
HUANG HSIN YI, National Taipei University of Nursing and Health Sciences

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

Condition or disease Intervention/treatment Phase
Hemodialysis Breathing Exercises Fatigue Other: Breathing exercises Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized hemodialysis patients in hospital
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. fatigue [ Time Frame: A 3-month ]
    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 :
  1. quality of life [ Time Frame: A 3-month ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499054


Locations
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Taiwan
Far Eastern Memorial Hospital
Taipei county, Taiwan, 220
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences

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Responsible Party: HUANG HSIN YI, Co-head of Nurses, AHN Department of Internal Medicine, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier: NCT03499054    
Other Study ID Numbers: 4rfvgy7m
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HUANG HSIN YI, National Taipei University of Nursing and Health Sciences:
Breathing exercises
fatigue
quality of life
Additional relevant MeSH terms:
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Respiratory Aspiration
Fatigue
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes