Downhill Walking in IPF
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Registration Number
- NCT06756230
- Lead Sponsor
- Saglik Bilimleri Universitesi
- Brief Summary
In this study; will examine the effects of downhill walking (eccentric exercise training) on exercise capacity, quality of life, and blood lactate levels in individuals with IPF. After the initial assessment, patients will be randomized into two groups: downhill walking PR group and Standard PR Group.
- Detailed Description
Individuals diagnosed with idiopathic pulmonary fibrosis who come to the Pulmonary Rehabilitation Unit of Istanbul Süreyyapaşa Chest Diseases and Chest Surgery Education and Research Hospital will be included in this study. Those who meet the inclusion criteria will be randomized into two groups: Downhill Walking Pr Group (n=17) and Standard Pr Group (n=17). Patients will have exercise sessions twice a week for 8 weeks. Patients will be evaluated immediately before the rehabilitation program and the end of 8 weeks exercise programme. In our study, downhill walking training will differ from traditional walking training only in terms of treadmill training protocol. Traditional walking training involves walking on a motorized treadmill with a neutral incline, progressing with increases in speed, while downhill walking training will be performed at a constant -10% incline.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 34
- Having a diagnosis of IPF according to the clinical diagnostic criteria of the American Thoracic Society and/or the European Respiratory Society (ATS-ERS).
- Being between the ages of 18 and 75.
- Being able to walk on a treadmill.
- Having the ability to cooperate.
- No change in current medication in the last month.
- Not participating in a structured activity program for at least six months.
- Accepting the purpose and method of this study voluntarily and give informed consent for the study.
- Presence of physical or mental impairment that prevents informed consent or compliance with the protocol.
- Inability to attend more than 20% of pulmonary rehabilitation sessions.
- Presence of major cardiovascular disease (coronary artery disease, uncontrolled hypertension, arrhythmias, or heart failure).
- Presence of existing orthopedic and neuromuscular exercise limitations.
- Acute exacerbation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 6 Minutes Walking Distance (6MWD) Baseline and the end of the 8 weeks exercise program 6 MWD means the distance the patient walked in 6 minute walk test. Its unit is meters.
Saint George Quality of life questionnaire Baseline and the end of the 8 weeks exercise program The St. George's Respiratory Questionnaire (SGRQ) is designed to measure quality of life. Four scores are calculated Symptoms, Activity, Impacts, and Total. Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
- Secondary Outcome Measures
Name Time Method Spirometric measurements (Forced vital capacity) Baseline and the end of the 8 weeks exercise program It is used to evaluate respiratory functions. It is evaluated with a spirometer. Forced vital capacity (FVC): the maximum amount of air that can be forcibly exhaled from the lungs after fully inhaling. It can be recorded in percentages or liters.
Spirometric measurements (First second forced expiratory volume) Baseline and the end of the 8 weeks exercise program It is used to evaluate respiratory functions. It is evaluated with a spirometer. First-second forced expiratory volume (FEV1): the amount of air that can be exhaled with force in 1 second. It can be recorded in percentages or liters.
Spirometric measurements (FEV1/FVC ratio) Baseline and the end of the 8 weeks exercise program It is used to evaluate respiratory functions. It is evaluated with a spirometer. It is calculated by dividing FEV1 by FVC. It is expressed as a percentage.
Peripheral muscle strength Baseline and the end of the 8 weeks exercise program Peripheral muscle strength will be assessed using a digital dynamometer. Quadriceps femoris muscle strength; will be measured by applying maximum resistance 2-3 cm above the ankle malleolus of the patients in a sitting position using an digital dynamometer.
Hand grip strength Baseline and the end of the 8 weeks exercise program Hand grip strength will be assessed in a sitting position. During the test, the arm will be measured next to the body, with the shoulder adducted, the elbows flexed at 90°, the forearm and wrist in a neutral position, and patients will be asked to grip and release the dynamometer as strongly as possible, and the measurement will be repeated 3 times on both dominant and non-dominant extremities and the averages will be recorded. A one-minute rest will be given between each trial.
Modified Medical Research Council Dyspnea Score Baseline and the end of the 8 weeks exercise program Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.
Fatigue severity scale Baseline and the end of the 8 weeks exercise program Fatigue levels of individuals will be assessed with the Fatigue Severity Scale (FSS). The FSS consists of 9 questions scored using a 7-point Likert scale, indicating a perception of fatigue that may require medical intervention.
Hospital anxiety depression scale (HADS) Baseline and the end of the 8 weeks exercise program A scale consisting of 14 items developed by Zigmond and Snaith. Seven of these items evaluate anxiety symptoms and seven evaluate depression symptoms. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3.
Determination of blood lactate level Baseline and the end of the 8 weeks exercise program Blood lactate level will be measured by fingertip sample using a portable lactate meter after a standardized exercise protocol applied before and after the intervention. Blood samples will be recorded in mmol/L after being analyzed by the device.
Carbon monoxide diffusion capacity Baseline and the end of the 8 weeks exercise program Carbon monoxide diffusion capacity (DLCO) is the measurement of the passage of carbon monoxide gas in inspired air into the lung capillary blood. Diffusion test is performed in the pulmonary function test laboratory.
Trial Locations
- Locations (1)
Saglik Bilimleri Universitesi
🇹🇷İstanbul, Üsküdar, Turkey