Effects of Diaphragmatic Kinesio Taping Combined With Pulmonary Rehabilitation on Diaphragm Muscle Thickness in Intensive Care Patients - NCT07929038

Sponsor: Bezmialem Vakif University Conditions: Respiratory Distress Syndrom This prospective, three-arm, randomized controlled trial aims to investigate the effects of diaphragmatic Kinesio taping applied in addition to pulmonary rehabilitation on diaphragm muscle thickness and function in intensive care unit (ICU) patients. A total of 48 patients admitted to the ICU due to respiratory distress will be recruited and randomly assigned to three groups: pulmonary rehabilitation combined with diaphragmatic Kinesio taping, pulmonary rehabilitation alone, and a control group receiving routine patient education. The interventions will be administered over a three-day period. Diaphragm muscle thickness during inspiration and expiration, diaphragm excursion, and diaphragm thickening fraction will be assessed using ultrasonography at baseline and after the intervention period. Cough-related quality of life, anxiety, and depression will also be evaluated using validated questionnaires. The study aims to determine whether adding diaphragmatic Kinesio taping to pulmonary rehabilitation provides additional benefits in preserving diaphragm muscle thickness and function in critically ill patients. Patients admitted to intensive care units are at risk of respiratory muscle weakness and diaphragm dysfunction due to prolonged immobilization, critical illness, and reduced physical activity. These complications may adversely affect respiratory function, exercise tolerance, mobility, and recovery. Pulmonary rehabilitation is an important component of intensive care management and may help reduce the consequences of immobilization and respiratory muscle dysfunction. Diaphragmatic Kinesio taping is a noninvasive therapeutic approach that may provide additional support to respiratory muscle function when combined with conventional rehabilitation. However, evidence regarding its effects on diaphragm muscle thickness and function in ICU patients remains limited. This prospective, three-arm, randomized controlled trial will be conducted in the intensive care unit of Istinye University Medical Park Gaziosmanpasa Hospital, Istanbul, Türkiye, between November and December 2026. A total of 48 eligible patients will be recruited and randomly allocated in a 1:1:1 ratio to one of three groups using computer-generated block randomization. Group allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher. The first group will receive pulmonary rehabilitation combined with diaphragmatic Kinesio taping. The second group will receive pulmonary rehabilitation alone. The third group will receive routine patient education as part of standard hospital care. The pulmonary rehabilitation program will be administered for three consecutive days and will include positioning, active-assisted range-of-motion exercises, breathing exercises, thoracic expansion exercises, incentive spirometry, and controlled coughing techniques. In the combined intervention group, Kinesio tape will be applied to the anterior and posterior aspects of the trunk along the diaphragmatic region and will remain in place for three days. Diaphragm muscle thickness at end-inspiration and end-expiration, diaphragm excursion, and diaphragm thickening fraction will be measured by an intensive care physician using ultrasonography. Measurements will be obtained at baseline and after three days. Each ultrasonographic measurement will be repeated three times, and the mean value will be recorded. Additional assessments will include cough-related quality of life using the Leicester Cough Questionnaire and anxiety and depression symptoms using the Hospital Anxiety and Depression Scale. The study will evaluate changes in diaphragm morphology and function and compare the effects of the three interventions over the study period.