Izmir University of Economics
Izmir, Balçova, 35330, Turkey (Türkiye)
NCT Number: NCT06842979
Strengthening the diaphragm muscle, the roof of the pelvic floor muscles (PFM), may be an alternative intervention in patients suffering from stress urinary incontinence (SUI). This study aims to investigate the effects of home-based telerehabilitation-assisted high-intensity inspiratory muscle training (IMT) on PFM function and urinary symptoms in women with SUI.
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Notify Me25 year–50 year
Female
Interventional
Not applicable
Izmir, Balçova, 35330, Turkey (Türkiye)
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 8 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload.
The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload.
Time frame: 8 weeks
Pressure feedbacks: Pelvic muscle functions were evaluated with pressure feedback of pelvic muscle using a biofeedback device (Myomed 932®- Enraf-Nonius, Delf, The Netherlands), and recorded in hPa (Hectopascal).
Time frame: 8 weeks
The manual muscle test was evaluated using the modified Oxford Scale, which ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
Time frame: 8 weeks
Urinary symptom was assessed with the Urogenital Distress Inventory-Short Form (range: 0-100) Higher values on this scale indicate worse symptoms.
Time frame: 8 weeks
Urinary incontinence symptom and its effect on the quality of life was assessed with the International Consultation on Incontinence Questionnaire-Short Form (range: 0-21) Higher values on this scale indicate worse symptoms.
Time frame: 8 weeks
Urinary incontinence severity was assessed with the Incontinence Severity Index (range: 1-12). Higher values on this scale indicate worse symptoms.
Time frame: 8 weeks
The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water).
Izmir University of Economics
Other
Effects of Home-based Telerehabilitation-assisted High-intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women With Stress Urinary Incontinence: A Randomized Controlled Study
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