MedTrace Logo

Inspiratory Muscle Training After Stroke

NCT07276477 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-01-14

No results posted yet for this study

Summary

Objective: To investigate and compare the efficacy of a 6-week, supervised respiratory training program using the AiroFit PRO™ mobile respiratory trainer against traditional Pursed-Lips Breathing exercises in individuals with hemiplegia.

Study Design: A single-blind, two-arm, randomized controlled trial.

Participants: Ambulatory adults with stable hemiplegia (≥3 months post-stroke), who are medically stable and able to follow commands.

Interventions: Participants will be randomly assigned to one of two groups:

Experimental Group: Will perform Inspiratory Muscle Training using the AiroFit PRO™ device for 15 minutes/day, 5 days/week, for 6 weeks. The intensity will be progressively increased.

Active Control Group: Will perform Pursed-Lips Breathing exercises for an identical duration and frequency.

Primary Outcomes: Changes in pulmonary function tests, including Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Maximal Inspiratory Pressure (MIP).

Significance: This study will provide high-level evidence on the utility of smart, device-guided respiratory training as a novel component of neurorehabilitation, potentially offering a more effective strategy to improve respiratory health and overall recovery in hemiplegic patients compared to standard breathing exercises.

Conditions

Interventions

OTHER

Device-Guided Inspiratory Muscle Training

The AiroFit™ PRO mobile respiratory trainer will be used.

OTHER

Pursed-Lips Breathing Training

Technique-based breathing exercise

OTHER

Concomitant Care

All participants will continue to receive their standard conventional neurorehabilitation therapy (e.g., physiotherapy, occupational therapy) as prescribed by their physician. This concomitant care will be documented for both groups to ensure equivalence.

Sponsors & Collaborators

  • Uşak University

    lead OTHER

Principal Investigators

  • Nihal Buker, Professor · Pamukkale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2026-05-11
Completion
2026-06-11

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07276477 on ClinicalTrials.gov