Comparison of Different Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis
- Conditions
- Pulmonary Sarcoidosis
- Interventions
- Other: Exercise- One-LeggedOther: Exercise-Two-Legged
- Registration Number
- NCT05368883
- Lead Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Brief Summary
Pulmonary rehabilitation is a key element in the management of people with chronic respiratory disease. A properly followed supervised physical training program in sarcoidosis is safe and has no absolute contraindications. Fatigue can also be associated with sarcoidosis for different reasons. Individualized rehabilitation training can improve the symptoms of patients with sarcoidosis. There is no study in the literature investigating the effectiveness of one-legged exercises that reduce peripheral muscle use, in patients with sarcoidosis. In our study, these two exercise methods will be compared by applying one-legged exercise training and two-legged exercise training. The effect of one-legged exercise training on exercise capacity and fatigue in sarcoidosis patients will be examined. The primary aim of our study is to compare the effects of one-legged exercise training, which is a current exercise approach, and two-legged exercise training on exercise capacity and fatigue in patients with sarcoidosis. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength and quality of life parameters.
- Detailed Description
Pulmonary rehabilitation is a key element in the management of individuals with chronic respiratory disease. A properly followed supervised physical training program in sarcoidosis is safe and has no absolute contraindications. Fatigue may be associated with different causes in sarcoidosis. Individualized rehabilitation practices can improve the symptoms of patients with sarcoidosis. There is no study in the literature investigating the effectiveness of one-legged exercises that reduce peripheral muscle use in patients with sarcoidosis. In our study, these two exercise methods will be compared by applying one-legged exercise training and two-legged exercise training. 26 patients will be randomly divided into 2 groups (n1=n2=13). While one group will receive one-legged cycling ergometer training, the other group will receive two-legged cycling ergometer training. After 8 weeks of exercise training, patients will be evaluated with, Pulmonary Function Test, Six-Minute Walk Test, Endurance Shuttle Walk test, Fatigue Assessment Scale, Multidimensional Fatigue Inventory, Blood Lactate Level (with lactate device), Medical Research Council Dyspnea Scale, Handheld dynamometer, St. George's Respiratory Questionnaire. The effect of one-legged exercise training on exercise capacity and fatigue in sarcoidosis patients will be examined. The primary aim of our study is to compare the effects of one-legged exercise training, which is a current exercise approach, and two-legged exercise training on exercise capacity and fatigue in patients with sarcoidosis. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength and quality of life parameters. The completion of the study will contribute to the determination of the content of the exercise programs to be applied in sarcoidosis patients and will reveal the effectiveness of one-legged exercise training, which is a current exercise method, in sarcoidosis patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
- Disease severity classified as stage 2, 3, or 4 based on chest X-ray findings FAS score ≥ 22 Patients being clinically stable No changes in their medical treatment
- Having orthopedic, neurological, cardiac, or metabolic conditions that could hinder participation in the exercise program and adherence to it during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One-legged cycling ergometer training Exercise- One-Legged One-legged cycling ergometer training; 10 minutes for each leg in the first 2 weeks, 15 minutes of cycling training in the following weeks. Two-legged cycling ergometer training Exercise-Two-Legged Two-legged cycling ergometer training; 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks.
- Primary Outcome Measures
Name Time Method Incremental Shuttle Walk Test 8 weeks The incremental shuttle walk test (ISWT) is a field-based assessment of cardiorespiratory fitness and physical function. The ISWT is a performance-based assessment of exercise and functional capacity that measures walking distance in meters. It is a relatively brief and easy test to perform. The ISWT simulates a maximal cardiopulmonary test in a field setting and requires minimal equipment. Longer walking distances signify better performance.
Change of Endurance Shuttle Walking Test Distance from baseline to 8 weeks 8 weeks Endurance Shuttle Walk test: This is a standardized field test for the assessment of endurance capacity. In the Endurance Shuttle Walk Test, the participant walks at a constant speed between cones spaced 10 m apart. The selected speed is 85% of the participant's maximum capacity measured in the shuttle walk test at increasing speed. Therefore, before this test, the patient should be given an increasing speed ıncremental shuttle walk test.
Change of Six-Minute Walking Test Distance from baseline to 8 weeks 8 weeks The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
- Secondary Outcome Measures
Name Time Method Change of Fatigue Assessment Scale results from baseline to 8 weeks 8 weeks Fatigue Assessment Scale: It includes five-point Likert type options (1=Always-5=Never). Higher scores indicate greater levels of fatigue.
Change of Multidimensional Fatigue Inventory results from baseline to 8 weeks 8 weeks The assessment includes 20 questions that encompass different dimensions of fatigue. These questions are divided into five subscales: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each subscale consists of 4 questions/statements and employs a 5-point Likert scale. Scores of 53 and above on the questionnaire indicate the presence of fatigue symptoms.
Change of Blood Lactate Level from baseline to 8 weeks 8 weeks To assess fatigue, blood lactate levels, which serve as an objective outcome measure, were taken before exercise, immediately after exercise, at the 5th minute post-exercise, and at the 20th minute post-exercise. A lactate measurement device was used for the blood lactate level measurements. For lactate analysis, a 0.2 μl capillary blood sample was required. Blood samples were taken from the patients' fingertips, placed on the device's strips, and inserted into the designated area of the device. The result was displayed on the device screen in mmol/L within 10 seconds, and the recorded value was noted.
Trial Locations
- Locations (1)
Istanbul University Cerrahpasa
🇹🇷Istanbul, Turkey