NCT06613048

Brief Summary

Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years. The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms 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
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

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

First Submitted

Initial submission to the registry

September 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

September 22, 2024

Last Update Submit

June 25, 2025

Conditions

Keywords

AnxietyFatiguequality of life

Outcome Measures

Primary Outcomes (3)

  • Beck Anxiety Inventory

    Beck Anxiety Inventory (BAI) is designed to measure the frequency of anxiety symptoms experienced by an individual. The scale, consisting of 21 items, is a Likert-type assessment scale scored between 0-3. Individuals rate each item by giving a score between 0-3 to determine how uncomfortable they have felt for the symptom in each item "including the day of the application, in the last week". The scale scores between 0-63. The high total score indicates the high level of anxiety experienced by the person. While 13 of the items describe physical symptoms, 3 reveal the cognitive aspects of anxiety. 3 items have a physical quality as well as a cognitive quality. Therefore, the BAI includes physiological, affective and cognitive symptoms of anxiety. The Cronbach Alpha value of the scale was determined as 0.92.

    6 week

  • Quality of Life Scale

    Quality of Life Scale (SF-12): SF-12; consists of two dimensions measuring physical (6 statements) and mental/psychological (6 statements) functioning. It includes various Likert-type statements (2-point Likert; yes-no or 5-point Likert; always, often, sometimes, very little, never etc.) regarding general health status, activity limits, depression, energy level etc. High scores indicate high quality of life.

    6 week

  • Piper Fatigue Scale

    Piper Fatigue Scale (PFS): PFS consists of 22 questions and subjectively evaluates fatigue perception. It has four sub-dimensions: the behavior/severity sub-dimension, which evaluates the effect and severity of fatigue on daily life activities; the affective sub-dimension, which covers the emotional meaning attributed to fatigue; the sensory sub-dimension, which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/spiritual sub-dimension, which reflects the degree to which fatigue affects cognitive functions and mood. The total score of the scale varies between 0 and 10. A score of 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, and 7-10 indicates severe fatigue.

    6 week

Study Arms (2)

Experimental (breathing exercise)

EXPERIMENTAL

The researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise. Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set. Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening).

Other: Breathing exercise

Control

NO INTERVENTION

The control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group.

Interventions

The researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise. Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set. Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening).

Experimental (breathing exercise)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over the age of 18
  • Being willing to participate in the study
  • Speaking and understanding Turkish
  • Having started hemodialysis treatment at least 6 months ago

You may not qualify if:

  • Being on hemodialysis treatment with a diagnosis of stage 4 renal failure
  • Being on hemodialysis treatment due to acute renal failure
  • Having a malignancy related to the respiratory system (bronchus or lung)
  • Having chest pain
  • Having previously done box breathing and diaphragmatic breathing exercises/receiving training
  • Having cognitive dysfunction
  • Not giving consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neşe Uysal

Amasya, 0500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityAnxiety DisordersFatigue

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

BehaviorMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Mahmut Zengin

    Amasya University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 25, 2024

Study Start

February 17, 2025

Primary Completion

May 26, 2025

Study Completion

June 23, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations