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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03499054
Other study ID # 4rfvgy7m
Secondary ID
Status Completed
Phase N/A
First received January 31, 2018
Last updated April 8, 2018
Start date March 1, 2017
Est. completion date June 30, 2017

Study information

Verified date February 2018
Source National Taiwan University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date June 30, 2017
Est. primary completion date June 15, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital Taipei county

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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