HemodialysisNCT03499054
Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
A study testing Breathing exercises in people with Hemodialysis and Breathing Exercises, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
Breathing exercises to improve fatigue and quality of life in hemodialysis patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodialysis, Breathing Exercises, Fatigue
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Breathing exercises to improve fatigue and quality of life in hemodialysis patients
Read the 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
- Conditions
- Hemodialysis, Breathing Exercises, Fatigue
- Being tested
- Breathing exercises
- Keywords
- Breathing exercises, fatigue, quality of life
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Hemodialysis patients in the control group who receive only routine nursing care during hemodialysis |
| exercise group | Experimental | The exercise group are asked to perform breathing exercises during hemodialysis for the study period of 3 months. Receives: Other: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: A 3-month
Secondary outcomes (1)
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
Measured: A 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Mar 2017
- Primary completion15 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized hemodialysis patients in hospital
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HUANG HSIN YI, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499054
- Sponsor's protocol ID
- 4rfvgy7m
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03499054
- Acronym / sponsor ID
- 4rfvgy7m
- Conditions
- Hemodialysis, Breathing Exercises, Fatigue
- Keywords
- Breathing exercises, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized hemodialysis patients in hospital
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Hemodialysis patients in the control group who receive only routine nursing care during hemodialysis |
| exercise group | Experimental | Other: Breathing exercisesThe exercise group are asked to perform breathing exercises during hemodialysis for the study period of 3 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exercisesDuring 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. | Other | exercise group |
Primary outcome
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
1 secondary outcome
quality of life
Time frame: A 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Hemodialysis and Breathing Exercises, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue (time frame: A 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.