NCT Number: NCT07031362
The aim of this study is to evaluate the effects of a pulmonary rehabilitation (PR) program on health outcomes and the distance-saturation product in patients with IPF, by comparing two distinct groups: those who experience desaturation and those who do not during the six-minute walk test (6MWT).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Exercise-induced dyspnea and desaturation are distinguishing features of patients with idiopathic pulmonary fibrosis (IPF); these symptoms are associated with disease severity and poorer prognosis. The distance-saturation product, which combines the distance walked and oxygen saturation by multiplying the two measures, has been identified as a predictor of mortality.
Patients with IPF who completed the pulmonary rehabilitation (PR) program were included in the study. Pre- and post-program assessments included spirometric measurements, arterial blood gas values, perception of dyspnea using the Modified Medical Research Council (mMRC) dyspnea scale, exercise capacity via the six-minute walk test (6MWT), health-related quality of life using the St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36), and psychological symptoms assessed with the Hospital Anxiety and Depression Scale (HADS). Additionally, the distance-saturation product was calculated by multiplying the distance walked by the oxygen saturation at the end of the 6MWT. Patients whose oxygen saturation dropped to 88% or below during the pre-rehabilitation 6MWT were classified as the desaturation group, while those with oxygen saturation of 89% or above were classified as the non-desaturation group. The obtained data were compared between these two groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinical diagnosis of Idiopathic Pulmonary Fibrosis Patients who initiated antifibrotic therapy Patients who completed the pulmonary rehabilitation program.
Exclusion criteria
All patients who participated in the pulmonary rehabilitation and physiotherapy program underwent sessions lasting approximately two hours, conducted twice weekly over a period of eight weeks. The exercise program included breathing exercises, relaxation and stretching exercises, peripheral muscle strengthening exercises, and aerobic training.
Time frame: up to 8 weeks
Six minute walk test
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. Higher scores mean a worse outcome.
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. Higher scores mean a worse outcome.
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Short Form-36 Survey is used to determine health-related quality of life. At this scale, high scores define a better perceived quality of life.
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Hospital Anxiety and Depression Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Izmir Katip Celebi University
Other
Effects of Pulmonary Rehabilitation on Distance-Saturation Product and Clinical Outcomes in IPF Patients With and Without Exercise-Induced Desaturation
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