Comparison of the Effects of One-Legged and Two-Legged Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis
Primary Purpose
Pulmonary Sarcoidosis
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise- One-Legged
Exercise-Two-Legged
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Sarcoidosis focused on measuring fatigue, exercise, quality of life, pulmonary sarcoidosis
Eligibility Criteria
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.
Sites / Locations
- Istanbul University Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
One-legged cycling ergometer training
Two-legged cycling ergometer training
Arm Description
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; 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05368883
First Posted
April 22, 2022
Last Updated
June 19, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05368883
Brief Title
Comparison of the Effects of One-Legged and Two-Legged Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis
Official Title
Comparison of the Effects of One-Legged and Two-Legged Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Sarcoidosis
Keywords
fatigue, exercise, quality of life, pulmonary sarcoidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One-legged cycling ergometer training
Arm Type
Experimental
Arm Description
One-legged cycling ergometer training; 10 minutes for each leg in the first 2 weeks, 15 minutes of cycling training in the following weeks.
Arm Title
Two-legged cycling ergometer training
Arm Type
Active Comparator
Arm Description
Two-legged cycling ergometer training; 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks.
Intervention Type
Other
Intervention Name(s)
Exercise- One-Legged
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise-Two-Legged
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Six-Minute Walking Test Distance from baseline to 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change of Endurance Shuttle Walking Test Distance from baseline to 8 weeks
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change of Fatigue Assessment Scale results from baseline to 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change of Multidimensional Fatigue Inventory results from baseline to 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change of Blood Lactate Level from baseline to 8 weeks
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Dyspnoea
Description
Change of Medical Research Council Scale results from baseline to 8 weeks. The Medical Research Council Scale (MRCS) is a five-item scale based on various physical activities that produce dyspnea. Here, patients are asked to mark the level of activity that causes dyspnea in themselves. On the scale, 0 describes the best 4 dyspnea and the worst.
Time Frame
8 weeks
Title
Muscle strength
Description
A hand-held dynamometer will be used to evaluate muscle strength. Muscle strength will be evaluated in the following muscles, each measurement will be made three times and the average will be taken.
M. Quadriceps Femoris, M. Tibialis Anterior, and M. Gastrosoleus
Time Frame
8 weeks
Title
Health Related Quality of Life
Description
Change of Saint George Respiratory Questionnaire Results from baseline to 8 weeks.It is a self-answered questionnaire consisting of three categories, evaluating the symptoms, activities and effects of patients on daily life. It was developed in order to determine the severity of the disease as more comprehensive and sensitive. Symptoms examined; cough, sputum, wheezing and shortness of breath. Physical functions, housework and hobbies are questioned to determine activity status. The survey consists of 76 questions and is completed in 20 minutes. 0 indicates excellent health and 100 indicates worst healt
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökşen KURAN ASLAN
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Cerrahpasa
City
Istanbul
ZIP/Postal Code
34320
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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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
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