NCT03499054

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

January 31, 2018

Last Update Submit

April 8, 2018

Conditions

Keywords

Breathing exercisesfatiguequality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • quality of life

    A 3-month

Study Arms (2)

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.

Other: Breathing exercises

Interventions

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.

exercise group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei County, 220, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized hemodialysis patients in hospital
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-head of Nurses, AHN Department of Internal Medicine

Study Record Dates

First Submitted

January 31, 2018

First Posted

April 17, 2018

Study Start

March 1, 2017

Primary Completion

June 15, 2017

Study Completion

June 30, 2017

Last Updated

April 17, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations