Comparison of the Effects of One-Legged and Two-Legged Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis

Study Overview
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Brief Summary
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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
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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. 60 patients will be randomly divided into 2 groups (n1=n2=30). 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.

Official Title
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Comparison of the Effects of One-Legged and Two-Legged Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis

Conditions
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Pulmonary Sarcoidosis

Intervention / Treatment
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* Other: Exercise- One-Legged
* Other: Exercise-Two-Legged


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According to chest X-ray findings, the severity of the disease is to be stage 2,3,4 Reaching a score of ≥ 22 on the fatigue assessment scale To be clinically stable. No change in medical treatment. Exclusion Criteria: Having an orthopedic, neurological, cardiac, or metabolic condition that may prevent participation and continuation of the exercise program throughout the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-legged cycling ergometer training<br>One-legged cycling ergometer training; 10 minutes for each leg in the first 2 weeks, 15 minutes of cycling training in the following weeks. | Other: Exercise- One-Legged<br>* One-legged cycling ergometer training will consist of 5 minutes of warm-up, 10 minutes for each leg in the first 2 weeks, 15 minutes of cycling training in the following weeks (5-10 minutes of rest while switching from one leg to the other leg) and a 5 minutes cool-down period. In the one-legged cycling ergometer training, it will be determined randomly that the patients start the exercise with the dominant or non-dominant leg. One-legged and two-legged exercise training will be maintained at moderate intensity (64-76%) according to maximum heart rate. Both groups will be given walking on flat ground once a week, with an exercise intensity of 11-13 according to the Borg scale, as home exercise.<br>|
| Active Comparator: Two-legged cycling ergometer training<br>Two-legged cycling ergometer training; 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks. | Other: Exercise-Two-Legged<br>* Two-legged cycling ergometer training will consist of 5 minutes of warm-up, 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks, and a 5 minutes cool-down period. One-legged and two-legged exercise training will be maintained at moderate intensity (64-76%) according to maximum heart rate. Both groups will be given walking on flat ground once a week, with an exercise intensity of 11-13 according to the Borg scale, as home exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Six-Minute Walking Test Distance from baseline to 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. | 8 weeks | 
| Change of Endurance Shuttle Walking Test Distance from baseline to 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fatigue Assessment Scale results from baseline to 8 weeks | Fatigue Assessment Scale: It was planned to use Fatigue Assessment Scale to evaluate subjective fatigue. The Fatigue Assessment Scale is a subjective fatigue questionnaire consisting of 10 items. It includes five-point Likert type options (1=Always-5=Never). Higher scores indicate greater levels of fatigue. | 8 weeks | 
| Change of Multidimensional Fatigue Inventory results from baseline to 8 weeks | Multidimensional Fatigue Inventory: It is used for the multidimensional evaluation of fatigue. It contains 20 questions containing different dimensions of fatigue. It consists of 5-point Likert-type questions. High scores indicate high fatigue. | 8 weeks | 
| Change of Blood Lactate Level from baseline to 8 weeks | Blood Lactate Level: Blood lactate level measurements, which are an objective outcome measure in the evaluation of fatigue, will be made, in the 1st week and 8th week, before the exercise, immediately after the exercise, at the 5th minute after the exercise, and at the 20th minute after the exercise. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, exercise, quality of life, pulmonary sarcoidosis