Pulmonary SarcoidosisNCT05368883
Comparison of Different Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis
A study testing Exercise- One-Legged and Exercise-Two-Legged in people with Pulmonary Sarcoidosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- Exercise- One-Legged and Exercise-Two-Legged
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having orthopedic, neurological, cardiac, or metabolic conditions that could hinder participation in the exercise program and adherence to it during the study period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, 34320
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- Exercise- One-Legged, Exercise-Two-Legged
- Keywords
- fatigue, exercise, quality of life, pulmonary sarcoidosis
- Medical subject headings
- Sarcoidosis, Pulmonary, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise- One-LeggedOther
The exercise program consisted of a 5-minute warm-up, followed by 10 minutes of cycling for each leg during the first 2 weeks, increasing to 15 minutes for each leg in the subsequent weeks (with a 5-10 minute rest period between switching legs), and concluded with a 5-minute cool-down period. During the exercise, the inactive leg was kept stationary and in contact with the ground . In the one-legged cycling exercise training, whether patients started with the dominant or non-dominant leg was determined randomly
Exercise-Two-LeggedOther
The exercise program consisted of a 5-minute warm-up, followed by 20 minutes of cycling during the first 2 weeks, increasing to 30 minutes in the subsequent weeks, and concluded with a 5-minute cool-down period.
| Study group | Role | What they receive |
|---|---|---|
| One-legged cycling ergometer training | Experimental | One-legged cycling ergometer training; 10 minutes for each leg in the first 2 weeks, 15 minutes of cycling training in the following weeks. Receives: Other: Exercise- One-Legged |
| Two-legged cycling ergometer training | Active comparator | Two-legged cycling ergometer training; 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks. Receives: Other: Exercise-Two-Legged |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (3)
Change of Fatigue Assessment Scale results from baseline to 8 weeks
Fatigue Assessment Scale: It includes five-point Likert type options (1=Always-5=Never). Higher scores indicate greater levels of fatigue.
Measured: 8 weeks
Change of Multidimensional Fatigue Inventory results from baseline to 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.
Measured: 8 weeks
Change of Blood Lactate Level from baseline to 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Mar 2023
- Primary completion21 Apr 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Tahmaz, Istanbul University - Cerrahpasa
- Investigators
- Gökşen KURAN ASLAN, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368883
- Sponsor's protocol ID
- Cerrahpasa University
- Status last verified
- Oct 2024
- First submitted
- 22 Apr 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tahmaz T, Aslan GK, Yeldan I, Okumus NG. Comparison of the effects of one-legged and two-legged exercise training on exercise capacity and fatigue in patients with sarcoidosis. Respir Med. 2025 Nov;248:108380. doi: 10.1016/j.rmed.2025.108380. Epub 2025 Sep 25.
PubMed 41015397
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of One-Legged and Two-Legged Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis
- ClinicalTrials.gov ID
- NCT05368883
- Acronym / sponsor ID
- Cerrahpasa University
- Conditions
- Pulmonary Sarcoidosis
- Keywords
- fatigue, exercise, quality of life, pulmonary sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-legged cycling ergometer training | Experimental | Other: Exercise- One-LeggedOne-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 | Active comparator | Other: Exercise-Two-LeggedTwo-legged cycling ergometer training; 20 minutes for the first 2 weeks, 30 minutes of cycling training in the following weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Having orthopedic, neurological, cardiac, or metabolic conditions that could hinder participation in the exercise program and adherence to it during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise- One-LeggedThe exercise program consisted of a 5-minute warm-up, followed by 10 minutes of cycling for each leg during the first 2 weeks, increasing to 15 minutes for each leg in the subsequent weeks (with a 5-10 minute rest period between switching legs), and concluded with a 5-minute cool-down period. During the exercise, the inactive leg was kept stationary and in contact with the ground . In the one-legged cycling exercise training, whether patients started with the dominant or non-dominant leg was determined randomly | Other | One-legged cycling ergometer training |
| Exercise-Two-LeggedThe exercise program consisted of a 5-minute warm-up, followed by 20 minutes of cycling during the first 2 weeks, increasing to 30 minutes in the subsequent weeks, and concluded with a 5-minute cool-down period. | Other | Two-legged cycling ergometer training |
Primary outcome
Change of Six-Minute Walking Test Distance from baseline to 8 weeks
Time frame: 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
Time frame: 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.
Incremental Shuttle Walk Test
Time frame: 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.
3 secondary outcomes
Change of Fatigue Assessment Scale results from baseline to 8 weeks
Time frame: 8 weeks
Change of Multidimensional Fatigue Inventory results from baseline to 8 weeks
Time frame: 8 weeks
Change of Blood Lactate Level from baseline to 8 weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41015397Tahmaz T, Aslan GK, Yeldan I, Okumus NG. Comparison of the effects of one-legged and two-legged exercise training on exercise capacity and fatigue in patients with sarcoidosis. Respir Med. 2025 Nov;248:108380. doi: 10.1016/j.rmed.2025.108380. Epub 2025 Sep 25.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
Not yet recruitingPhase 2
LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Sarcoidosis Associated Pulmonary Hypertension
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
Sarcoidosis, Pulmonary
Not yet recruitingPhase 2
A Clinical Trial of Tulisokibart (MK-7240) in Participants With Pulmonary Sarcoidosis (MK-7240-016)
Pulmonary Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökşen KURAN ASLAN study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise- One-Legged and Exercise-Two-Legged in people with Pulmonary Sarcoidosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Six-Minute Walking Test Distance from baseline to 8 weeks (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05368883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.