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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Sarcoidosis
• Intervention / Treatment: Other: Exercise- One-Legged; Other: Exercise-Two-Legged

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34320
    • Istanbul University Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-legged cycling ergometer training; 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; 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.
Active Comparator: Two-legged cycling ergometer training; 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; 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.

What is the study measuring?

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
Incremental Shuttle Walk Test	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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnoea	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.	8 weeks
Muscle strength	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	8 weeks
Health Related Quality of Life	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	8 weeks
The Leicester Cough Questionnaire (LCQ)	Change of The Leicester Cough Questionnaire (LCQ) Results from baseline to 8 weeks. The Leicester Cough Questionnaire (LCQ) is a HRQoL questionnaire validated for assessing chronic cough. It is a 19-item, self-completed questionnaire exploring the impact of cough severity across three domains: physical (eight items), psychological (seven items) and social (four items). The total severity score ranges from 3 to 21, with a lower score indicating greater impairment of health status due to cough.	8 weeks

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Study Director: Gökşen KURAN ASLAN, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 21, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: fatigue; exercise; quality of life; pulmonary sarcoidosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Hypersensitivity; Lung Diseases, Interstitial; Hypersensitivity, Delayed; Fatigue; Sarcoidosis, Pulmonary; Sarcoidosis
• Other Study ID Numbers: Cerrahpasa University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No