NCT07183696

Brief Summary

This study investigates the effect of breath booster training on respiratory muscle strength and quality of life in patients undergoing hemodialysis. It aims to determine whether targeted respiratory training can improve pulmonary function, enhance physical performance, and positively impact overall well-being in this population.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 11, 2025

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Respiratory Muscle Strength measured using Respiratory Pressure Manometers

    Outcomes include maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), recorded in cmH₂O. Higher values indicate greater respiratory muscle strength.

    6 weeks

  • Health-Related Quality of Life assessed by the 36-Item Short Form Health Survey

    It includes eight domains (physical functioning, role limitations, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Scores are transformed to a 0-100 scale, where 0 = worst health and 100 = best health. Higher scores indicate better health-related quality of life.

    for 6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

will receive respiratory physical therapy sessions in the form of breathing exercises, chest percussion, and vibration 3 times per week during dialysis sessions for 6 weeks

Other: breathing exercises

Intervention Group

EXPERIMENTAL

will receive respiratory physicaltherapy sessions in the form of breathing exercises, chest percussion, and vibration 3 times per week during dialysis sessions for 6 weeks and training on the breath booster device at the same session

Other: breathing exercises

Interventions

* breathing exercises as needed 3 times per week during dialysis sessions. * chest percussion as needed 3 times per week during dialysis sessions. * vibration as needed 3 times per week during dialysis sessions.

Also known as: chest percussion, vibration
Intervention GroupPlacebo

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fifty patients will be included in this study.
  • Their ages will range from 50 to 60 years.
  • Patients with end-stage renal disease (grade 5) receiving hemodialysis.
  • Patients on hemodialysis for around 1 to 3 years.
  • They will be able to follow instructions during evaluation and treatment.

You may not qualify if:

  • Diabetes Mellitus,
  • Morbid obesity with a BMI of more than 35 kg/m2.
  • Hearing or visual impairments.
  • Any severe chest diseases like COPD.
  • Certain contraindications for the use of the Breath Booster. Individuals with severe respiratory conditions such as unstable asthma, or emphysema, or those who have recently undergone lung surgery
  • Uncontrolled seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy cairo university

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Breathing ExercisesVibration

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesMechanical PhenomenaPhysical Phenomena

Central Study Contacts

Sameh Eldaly Sameh Eldaly

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of scientific research committee

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 19, 2025

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations