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Effect of Exercises on Ventilatory Function in Adult With TOF

NCT07326228 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . The main questions it aims to answer is:

* Dose combined inspiratory muscle training and aerobic exercise (study group) improve ventilatory function in adults with repaired (TOF) more than aerobic exercise only (control group)?
* Can combine inspiratory muscle training and aerobic exercise (study group) raise functional capacity and (QoL) in adults with repaired (TOF) more than aerobic exercise only (control group)?

Researchers will compare between combination of inspiratory muscle training and aerobic exercise on one group and the aerobic exercise only on other group, on ventilatory function, functional capacity and (QoL) on adults with repaired TOF.

Participants will:

On study group , participants will perform respiratory muscle training in addition to moderate intensity aerobic exercise for 6 weeks. 3 times/week

On controlled group , participants will perform moderate intensity aerobic exercise for 6 weeks. 3 times/week.

all participants will test ventilatory function , functional capacity and will answer a survey questions about their quality of life before and after training

Conditions

  • Tetralogy of Fallot (TOF)
  • Adults With Repaired Tetralogy of Fallot

Interventions

OTHER

aerobic exercise

moderate intensity aerobic exercises on a treadmill: * Symptom-limited treadmill exercise training will be carried out at baseline for each participant following the modified Bruce protocol to estimate each participant's peak heart rate. * the target heart rate during training will be 50-60 % of each participant's heart rate reserve (moderate intensity exercise) * each session will have 5-10 min warm up, at least 20 min of moderate intensity aerobic exercise , and 5-10 min of cool down

OTHER

respiratory muscle training

respiratory muscle training via threshold inspiratory muscle trainer (IMT) device: * maximum inspiratory effort will be detected for each participant as the maximum resistance at which the participant can efficiently achieve 10 breathing cycles, via (Threshold IMT device) * the training will be initiated with a low-intensity load (20-30%) of the participant's maximum inspiratory effort via (Threshold IMT device). Then, the intensity will increase gradually by 5% according to the participant's tolerance weekly until achieving 50% of maximum inspiratory effort. * the session will be formed of six sets, each set consisting of five deep breaths against the (Threshold IMT device), with a short interval of 1-2-minute rest between sets.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2027-01-31

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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 NCT07326228 on ClinicalTrials.gov