NCT06706024

Brief Summary

Purpose: To examine the effects of breathing exercises on respiratory functions and 6 Minute Walk Test (6 WT) distance in patients receiving hemodialysis treatment. Method: This is a quasi-experimental study with a single group pretest-posttest design. It was conducted with 30 individuals in the hemodialysis unit of a public hospital between July 2022 and October 2022. Data were also collected before starting the intervention (week 1) and after completing the intervention (week 8). Socio-Demographic Data Survey, 6 Minute Walk Test and Respiratory Function Test were used as data collection tools and data were collected face to face. In the analysis of the data, mean, standard deviation, percentage, t test in dependent groups, and Wilcoxon analysis were used. KeyWords: Individuals receiving hemodialysis treatment, respiratory exercise program, nursing care

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

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

July 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

March 18, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

hemodialysis patientbreathing exercise programnursing care

Outcome Measures

Primary Outcomes (4)

  • Respiratory Function Test- FVC

    Forced Vital Capacity (FVC): The amount of air that is exhaled forcefully and rapidly after taking as much breath as possible.

    0- 8. weeks

  • Respiratory Function Test- FEV1

    1st Second Forced Expiratory Volume (FEV1): The amount of air exhaled in the first second of the FVC test.

    0- 8. weeks

  • Respiratory Function Test- FEF

    Forced Expiratory Flow (FEF): The average flow rate during the middle half of the FVC test.

    0- 8. weeks

  • Respiratory Function Test- PEFR

    Peak Expiratory Flow Rate (PEFR): The maximum airflow rate achieved during a forced exhalation.

    0- 8. weeks

Study Arms (1)

respiratory exercise program

EXPERIMENTAL

A practical explanation was given about how to use the flow-oriented Intensive Spirometry Device (ICC) (Triflow) after the 3rd hour of the treatment in the HD unit. Each of the patients was given the same brand and model flow-focused intensive spirometer (Triflow) device for breathing exercise.

Other: breathing exercise

Interventions

Patients Under Hemodialysis

Also known as: 6 minute walking test
respiratory exercise program

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being ≥18 years old;
  • Receiving HD treatment three times a week for at least 3 months;
  • Not having a condition that prevents walking;

You may not qualify if:

  • Having a history of Myocardial Infarction or Anginapectoris within the last month,
  • Uncontrolled arrhythmia and heart rate \>120/min,
  • Having uncontrolled hypertension (BP\>180/100 mm-Hg),
  • Having a history of cerebrovascular accident
  • Having advanced stage COPD (Stage 3, Stage 4) and advanced Stage Heart Failure (Stage 3/Stage 4),
  • Having profound anemia (Hb\<7 g/dl),
  • Having a history of blood transfusion in the last month,
  • Having an active and chronic infection (Tuberculosis, osteomyelitis, rheumatoid arthritis),
  • Needing additional oxygen therapy,
  • Hospitalization in the last 1 month,
  • Patients with physical or mental health problems that would prevent communication were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çankiri Karatekin University

Çankırı, Ori̇ji̇n, 18100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a quasi-experimental study with a single group pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 18, 2024

First Posted

November 26, 2024

Study Start

July 15, 2022

Primary Completion

October 15, 2022

Study Completion

October 15, 2022

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations