Interstitial Lung DiseaseNCT06087692
Efficacy of Video-Based Interactive Game Therapy in Interstitial Lung Patients
A study testing Exercise in people with Interstitial Lung Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with ILD (Interstitial lung disease) by a chest diseases specialist, aged between 40-65 years, and have been under follow-up for at least 6 months according to the current ATS/ERS guidelines.
- Clinically stable, with no exacerbations or infections.
- Able to walk, with no visual or auditory impairments.
- Patients with cognitive abilities sufficient to understand commands.
Who cannot join
- Orthopedic and neurological problems that could hinder exercise training.
- Changes in medical treatment during the study.
- Unstable cardiac diseases.
- Insufficient cooperation.
- Diagnosed visual, auditory, vestibular, or neurological problems that could affect balance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Faculty of Medicine
Istanbul, 34093
Melike Sarıtaş Arslan, PHDc, 5542320882, mlksrts@hotmail.com
About this study
Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence.
Read the detailed description
Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. Many forms of ILD are progressive over time, associated with severely disabling symptoms and poor quality of life, yet medical treatment options are often limited. There are no specific pulmonary rehabilitation guidelines for this patient population, and standard programs are adapted on a patient basis. However, it is seen that the participation and attendance of patients in pulmonary rehabilitation programs is low, and the benefits obtained from the programs are gradually lost after completing the intensive rehabilitation process and breaking contact with the rehabilitation team. For these reasons, the guidelines emphasize the need to implement new strategies that can overcome limitations, and it is stated that there is a need for research and development of new program models that will make evidence-based pulmonary rehabilitation more accessible for patients. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence.
Hypotheses:
H0: Video-based game therapy applied in addition to aerobic exercise in patients with ILD has has no effect on exercise capacity, quality of life and physical fitness level.
H1: Video-based game therapy applied in addition to aerobic exercise in patients with ILD increases exercise capacity, quality of life and physical fitness level.
Patients in the Nintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 30 minutes. Patients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist. After eight weeks, all assessments will be repeated.
As a result of this study, the contribution of video-based interactive game therapy to exercise capacity, peripheral muscle strength, physical activity level, symptoms, activity and participation levels in patients with ILD will be determined and compared.
- Conditions
- Interstitial Lung Disease
- Being tested
- Exercise
- Keywords
- Video-based game therapy, Aerobic Exercise
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
-based game therapy applied in addition to aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Other | Patients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist. Receives: Other: Exercise |
| Nintendo +aerobic exercise | Other | Nintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 30 minutes. Receives: Other: Exercise |
| Control | Other | Physical activity recommendation and respiratory exercises Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
6 minute walk test:Used to determine submaximal functional exercise capacity. Patients are asked to walk as far as possible in a 30-meter straight corridor at their own walking pace for six minutes. The patient rests in a sitting position for 10 minutes in the corridor before starting the test. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The distance walked in six minutes is recorded.
Measured: through study completion, an average of 1 year
Incremental Shuttle Walk Test
Incremental Shuttle Walk Test (ISWT): Used to determine functional exercise capacity. Patients walk around a cassette with signals previously recorded at a rate of 0.17 m/s, which increases every minute, starting at a pace of 10 meters per minute. The test consists of a maximum of 12 stages. The test is terminated if the patient cannot complete it within the allowed time (if the patient is more than 0.5 meters away from the signal cone when the signal sounds) or if the patient reaches 85% of the predicted maximum heart rate calculated according to the formula [210 - (0.65 x age)]. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking distance is recorded.
Measured: through study completion, an average of 1 year
Endurance Shuttle Walk Test
Endurance Shuttle Walk Test (ESWT): Endurance capacity is determined using ESWT. The walking speed (workload) to be used in ESWT will be calculated as 85% of the maximum sustainable speed obtained from ISWT. Patients are asked to warm up by walking at a slower pace for two minutes and then to walk at a steady pace. The test is terminated if the patient feels too breathless to continue walking, becomes fatigued, or completes the 20-minute test duration. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking time is recorded in seconds.
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Respiratory Muscle Strength
Measurement of respiratory muscle strength will be performed using an electronic mouth pressure measurement device, the "MicroRPM" brand (Micro Medical; UK), in accordance with ATS and ERS criteria.
Measured: through study completion, an average of 1 year
Muscle strength
Quadriceps Function Assessment;Quadriceps muscle strength will be evaluated using a hand-held dynamometer (J-Tech CommanderTM Muscle Tester, USA) by performing maximal voluntary isometric contractions (break test).
Measured: through study completion, an average of 1 year
Dyspnea
The Modified Medical Research Council Scale is used to assess the level of dyspnea experienced in daily life.The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 4 (normal) to Grade 0 (no visible contraction).
Measured: through study completion, an average of 1 year
Fatigue
A 9-item Fatigue Severity Scale is created by selecting fatigue-related characteristics. Each question is rated on a scale of 1-7, with 1 indicating no effect and 7 indicating a high impact. The total score is calculated as the sum or average of all responses.
Measured: through study completion, an average of 1 year
The Saint George Respiratory Questionnaire
The Saint George Respiratory Questionnaire (SGRQ) is used to assess health-related quality of life. It consists of 50 questions and three subscales: symptoms, activity, and impact.Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: through study completion, an average of 1 year
Daily Life Activities:
The London Chest Activity of Daily Living Scale (LCADL) is used to assess daily life activities and their impact on breathlessness. The scale has 4 subgroups; self-care (4 question), about home (six question), physical activity (2 question) and leisure time (3 question). The minimum score is 0 and maximum score is 75. Higher scores indicate worse conditions.
Measured: through study completion, an average of 1 year
International Physical Activity Questionnaire (Short Form)
This questionnaire is used to determine the level of physical activity.
- Inactive-No activity is reported OR
- Some activity is reported but not enough to meet Categories 2 or 3.
- Minimally Active Any one of the following 3 criteria
- 3 or more days of vigorous activity of at least 20 minutes per day OR
- 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR
- 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.
- active Any one of the following 2 criteria
- Vigorous-intensity activity on at least 3 days and accumulating at least 1500 METminutes/week OR
- 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Measured: through study completion, an average of 1 year
Leicester Cough Questionnaire
Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic coug. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score. It generally takes about 5 minutes to be completed and it is designed for adults.The total severity score ranges from 3 to 21, with a lower score indicating greater impairment of health status due to cough.
Measured: through study completion, an average of 1 year
Global rating of change (GRC)
Global rating of change (GRC): Patient satisfaction was assessed by GRC at the end of the study. Global rating of change (GRC) scales are designed to quantify a patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition (21). The responses for the GRC were "much better"; "slightly better"; "stayed the same"; "slightly worse" or "much worse".
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Factorial
- Model description
- Randomized-Controlled
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Sarıtas Arslan, Istanbul University
- Investigators
- Aysel Yıldız Özer, Prof., Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087692
- Sponsor's protocol ID
- PHD Thesis
- Status last verified
- Nov 2024
- First submitted
- 6 Oct 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Thorax. 2008 Jun;63(6):549-54. doi: 10.1136/thx.2007.088070. Epub 2008 Feb 1.
PubMed 18245143Arslan MS, Ozer AY, Bingol Z, Okumus G. Effectiveness of Active Video Games as a Training Tool in Patients With Interstitial Lung Disease: A Randomised Controlled Trial. Respirology. 2026 Mar;31(3):265-275. doi: 10.1002/resp.70166. Epub 2025 Dec 4.
PubMed 41344887
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Video-Based Interactive Game Therapy in Interstitial Lung Patients
- ClinicalTrials.gov ID
- NCT06087692
- Acronym / sponsor ID
- PHD Thesis
- Conditions
- Interstitial Lung Disease
- Keywords
- Video-based game therapy, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Oct 2023 (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.
Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence.
Detailed description
Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. Many forms of ILD are progressive over time, associated with severely disabling symptoms and poor quality of life, yet medical treatment options are often limited. There are no specific pulmonary rehabilitation guidelines for this patient population, and standard programs are adapted on a patient basis. However, it is seen that the participation and attendance of patients in pulmonary rehabilitation programs is low, and the benefits obtained from the programs are gradually lost after completing the intensive rehabilitation process and breaking contact with the rehabilitation team. For these reasons, the guidelines emphasize the need to implement new strategies that can overcome limitations, and it is stated that there is a need for research and development of new program models that will make evidence-based pulmonary rehabilitation more accessible for patients. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence.
Hypotheses:
H0: Video-based game therapy applied in addition to aerobic exercise in patients with ILD has has no effect on exercise capacity, quality of life and physical fitness level.
H1: Video-based game therapy applied in addition to aerobic exercise in patients with ILD increases exercise capacity, quality of life and physical fitness level.
Patients in the Nintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 30 minutes. Patients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist. After eight weeks, all assessments will be repeated.
As a result of this study, the contribution of video-based interactive game therapy to exercise capacity, peripheral muscle strength, physical activity level, symptoms, activity and participation levels in patients with ILD will be determined and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized-Controlled
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Other | Other: ExercisePatients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist. |
| Nintendo +aerobic exercise | Other | Other: ExerciseNintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 30 minutes. |
| Control | Other | Other: ExercisePhysical activity recommendation and respiratory exercises |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with ILD (Interstitial lung disease) by a chest diseases specialist, aged between 40-65 years, and have been under follow-up for at least 6 months according to the current ATS/ERS guidelines.
- Clinically stable, with no exacerbations or infections.
- Able to walk, with no visual or auditory impairments.
- Patients with cognitive abilities sufficient to understand commands.
Key exclusion criteria (5 listed)
- Orthopedic and neurological problems that could hinder exercise training.
- Changes in medical treatment during the study.
- Unstable cardiac diseases.
- Insufficient cooperation.
- Diagnosed visual, auditory, vestibular, or neurological problems that could affect balance.
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-based game therapy applied in addition to aerobic exercise | Other | Aerobic Exercise, Control, Nintendo +aerobic exercise |
Primary outcome
6 minute walk test
Time frame: through study completion, an average of 1 year
6 minute walk test:Used to determine submaximal functional exercise capacity. Patients are asked to walk as far as possible in a 30-meter straight corridor at their own walking pace for six minutes. The patient rests in a sitting position for 10 minutes in the corridor before starting the test. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The distance walked in six minutes is recorded.
Incremental Shuttle Walk Test
Time frame: through study completion, an average of 1 year
Incremental Shuttle Walk Test (ISWT): Used to determine functional exercise capacity. Patients walk around a cassette with signals previously recorded at a rate of 0.17 m/s, which increases every minute, starting at a pace of 10 meters per minute. The test consists of a maximum of 12 stages. The test is terminated if the patient cannot complete it within the allowed time (if the patient is more than 0.5 meters away from the signal cone when the signal sounds) or if the patient reaches 85% of the predicted maximum heart rate calculated according to the formula [210 - (0.65 x age)]. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking distance is recorded.
Endurance Shuttle Walk Test
Time frame: through study completion, an average of 1 year
Endurance Shuttle Walk Test (ESWT): Endurance capacity is determined using ESWT. The walking speed (workload) to be used in ESWT will be calculated as 85% of the maximum sustainable speed obtained from ISWT. Patients are asked to warm up by walking at a slower pace for two minutes and then to walk at a steady pace. The test is terminated if the patient feels too breathless to continue walking, becomes fatigued, or completes the 20-minute test duration. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking time is recorded in seconds.
9 secondary outcomes
Respiratory Muscle Strength
Time frame: through study completion, an average of 1 year
Muscle strength
Time frame: through study completion, an average of 1 year
Dyspnea
Time frame: through study completion, an average of 1 year
Fatigue
Time frame: through study completion, an average of 1 year
The Saint George Respiratory Questionnaire
Time frame: through study completion, an average of 1 year
Daily Life Activities:
Time frame: through study completion, an average of 1 year
International Physical Activity Questionnaire (Short Form)
Time frame: through study completion, an average of 1 year
Leicester Cough Questionnaire
Time frame: through study completion, an average of 1 year
Global rating of change (GRC)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 18245143Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Thorax. 2008 Jun;63(6):549-54. doi: 10.1136/thx.2007.088070. Epub 2008 Feb 1.
- Derived from this study: PubMed 41344887Arslan MS, Ozer AY, Bingol Z, Okumus G. Effectiveness of Active Video Games as a Training Tool in Patients With Interstitial Lung Disease: A Randomised Controlled Trial. Respirology. 2026 Mar;31(3):265-275. doi: 10.1002/resp.70166. Epub 2025 Dec 4.
- Individual participant dataSharing planned: No
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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.
Aysel Yıldız Özer, Prof. study director
Marmara University
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 in people with Interstitial Lung Disease, run by Istanbul University 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melike Sarıtaş Arslan, PhdC (5542320882, mlksrts@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: through study completion, an average of 1 year). 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 NCT06087692, which also lists 2 linked publications.
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 19 Nov 2024.