Primary ImmunodeficiencyNCT06092528

Investigation of the Effects of Pulmonary Rehabilitation in Children With Primary Immunodeficiency

A study testing Inspiratory muscle training, Upper extremity aerobic exercise training and Lower extremity aerobic exercise training in people with Primary Immunodeficiency, run by Gazi University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Primary Immunodeficiency
What is being tested?: Inspiratory muscle training, Upper extremity aerobic exercise training and Lower extremity aerobic exercise training
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Nov 2023to 20 Sep 2026
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 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

-Patients aged 6-18 years with primary immunodeficiency

Who cannot join

Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
Serious neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions
Participating in a planned exercise program in the past three months
Cognitive impairment, which may cause difficulty understanding and following exercise test instructions

Trial locations and contacts

1 site in 1 country.

Meral Boşnak Güçlü, Prof. Dr. contact

03122162647

meralbosnak@gazi.edu.tr

Betül Yoleri, Pt. MsC contact

betulyoleri@gazi.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
Meral BOŞNAK GÜÇLÜ, Prof.Dr., +903122162647, meralbosnak@gazi.edu.tr
Betül Yoleri, Pt. MsC, betulyoleri@gazi.edu.tr
Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Pulmonary Rehabilitation on Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Children With Primary Immunodeficiency

Primary immunodeficiencies (PID) are a heterogeneous group of diseases that occur as a result of disorders that affect the development, differentiation and/or function of various cells and building blocks in the immune system. Among the symptoms and complications of PID, pulmonary complications are very common and significantly increase the morbidity and mortality of the disease.

Read the detailed description

Among the symptoms and complications of PID, pulmonary complications are very common and significantly increase the morbidity and mortality of the disease. Recurrent respiratory infections are often the first warning sign in some types of PID and is a cause of mortality in adults with PID. Presence of 2 or more pneumonias per year is one of the 10 warning signs of PID. Respiratory system diseases are mainly caused by acute and chronic infections. Non-infectious respiratory system diseases and complications are asthma, bronchiectasis, bronchiolitis obliterans, interstitial lung disease, granulomatous lung disease and malignancies. These diseases significantly affect the quality of life of PID patients, limiting their ability to work and their physical and social activities. Health-related quality of life in PID patients is also significantly affected by delays in the diagnosis and treatment of infections. As survival from infections increases, non-infectious pulmonary complications are more common in PID patients. Permanent lung damage is seen at a rate of 20-40%, especially in PID patients with antibody deficiency. The main causes of exercise intolerance in patients with lung disease include isolated or associated factors such as increased symptoms (fatigue and shortness of breath in the lower extremities), development of dynamic hyperinflation, peripheral muscle dysfunction, abnormalities in oxygen transport and progressive loss of physical condition, physical inactivity. There are no studies evaluating exercise capacity, respiratory and peripheral muscle strength, inspiratory muscle endurance, and muscle oxygenation in children with PID. In studies conducted with post-infectious bronchiolitis obliterans patients, it has been shown that exercise capacity is reduced in these patients. There are no studies in the literature on pulmonary rehabilitation practices and efficacy in PID patients.

The primary aim of this study: To investigate the effects of pulmonary rehabilitation on exercise capacity and muscle oxygenation in children with primary immunodeficiency.

The secondary aim of this study: To investigate the effects of pulmonary rehabilitation on physical activity level, respiratory functions, peripheral and respiratory muscle strength, inspiratory muscle endurance, shortness of breath, fatigue and quality of life in children with primary immunodeficiency.

Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).

Secondary outcome will be muscle oxygenation (Moxy device), physical activity level (multi sensor activity device), pulmonary function (spirometer), functional exercise capacity (six-minute walk test), respiratory (mouth pressure device) and peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), dyspnea (Modified Borg Scale (MBS)), fatigue (Modified Borg Scale) and quality of life (The Pediatric Quality of Life Inventory (PedsQL)).

Conditions: Primary Immunodeficiency
Being tested: Inspiratory muscle training, Upper extremity aerobic exercise training, Lower extremity aerobic exercise training, Resistant exercise training, Thoracic expansion exercises
Keywords: primary immunodeficiency, pulmonary rehabilitation, exercise capacity, muscle oxygenation, physical activity
Medical subject headings: Primary Immunodeficiency Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inspiratory muscle trainingOther
Inspiratory muscle training will be performed with Power Breathe®. Inspiratory muscle training will be given to the training group, starting from 50% of the MIP, and 2 sessions/day, 15 minutes/session. Patients will be asked to check breathing for 4-5 breaths after 8-10 consecutive breathing cycles. The patient will continue this cycle for 15 minutes.
Upper extremity aerobic exercise trainingOther
Upper extremity aerobic exercise training will be performed 3 days/week, 1 session/day, 15 min/session using arm ergometer device accompanied by a physiotherapist. Aerobic exercise training workload will be 60-80% of maximal heart rate. In this study, the perception of dyspnea will be between 3-4, arm fatigue and general fatigue perception will be between 5-6, warm-up and cool-down periods will be 5 minutes, and pedaling speed will be 40-50 rev/min, according to MBS.
Lower extremity aerobic exercise trainingOther
Lower extremity aerobic exercise training will be performed 3 days/week, 1 session/day, 15 minutes/session using the treadmill device, accompanied by a physiotherapist. Aerobic exercise training workload was set at 60-80% of maximal heart rate, dyspnea perception according to MBS was between 3-4, arm fatigue and general fatigue perception was between 5-6, and warm-up and cool-down periods were 5 minutes.
Resistant exercise trainingOther
Upper and lower additional limb strengthening training will be performed 3 days/week, 1 session/day, 10 repetitions/sessions from the first day by using bullion weights in the presence of a physiotherapist. The upper extremity strengthening program will consist of a progressive exercise program to strengthen the shoulder flexors and abductors, and the lower extremity strengthening program to strengthen the knee extensors. The training workload will be increased progressively. For strength training, the workload will be adjusted so that the perception of fatigue is between 4 and 6 according to MBS.
Thoracic expansion exercisesOther
The control group will be asked to do thoracic expansion exercises seven days/week and 120 pieces/day for six weeks.

Study groups in NCT06092528
Study group	Role	What they receive
Pulmonary Rehabilitation Group	Experimental	Pulmonary rehabilitation practices (inspiratory muscle training, aerobic exercise training, resistance exercise training) will be performed 3 sessions a week for 6 weeks under the supervision of a physiotherapist to the training group. Receives: Other: Inspiratory muscle training; Other: Upper extremity aerobic exercise training; Other: Lower extremity aerobic exercise training; Other: Resistant exercise training
Control Group	Sham comparator	Control group will be given breathing exercises as a home program for 6 weeks. Receives: Other: Thoracic expansion exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

Oxygen Consumption
Cardiopulmonary Exercises Test
Measured: First Day

Secondary outcomes (20)

Pulmonary function (Forced vital capacity (FVC))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. With the device, forced vital capacity (FVC) will be evaluated.
Measured: Second Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Measured: Second Day
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, FEV1 / FVC will be evaluated.
Measured: Second Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Measured: Second Day
Pulmonary function (Peak flow rate (PEF))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, peak flow rate (PEF) will be evaluated.
Measured: Second Day
Respiratory Muscle Strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria
Measured: Second Day
Respiratory Muscle Endurance
Incremental threshold loading test
Measured: Second Day
Peripheral Muscle Strength
Hand held dynamometer
Measured: Second Day
Functional exercise capacity
6 minute walking test
Measured: Second Day
Quality of Life (For Children)
The Pediatric Quality of Life Inventory (PedsQL): It includes 8 items that measure physical functionality, 5 items that measure emotional functionality, 5 items that measure social functionality, and 5 items that assess functionality at school. There are separate forms for parents and children. There are separate scales for children 5-7 years old, 8-12 years old and 13-18 years old. For parents, there are separate forms for 2-4 years, 5-7 years, 8-12 years and 13-18 years. Items are scored between 0-100. The higher the total PedsQL score, the better the health-related quality of life is perceived.
Measured: First Day
Dyspnea
Modified Borg Scale: The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.
Measured: First and Second Day
Fatigue
Modified Borg Scale: The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.
Measured: First and Second Day
Muscle oxygenation
Moxy® monitor
Measured: First and Second Day
Physical Activity Level (Total energy expenditure)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Active energy expenditure (joule / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Active energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Physical activity time (min / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Physical activity time (min / day)will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Average metabolic equivalent (MET / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Average metabolic equivalent (MET / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Number of steps (steps / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Number of steps (steps / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Time spent lying down (min / day) days))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Time spent lying down (min / day) days) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Sleep time (min / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Sleep time (min / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202320 Sep 2026

First posted23 Oct 2023
Study start1 Nov 2023
Primary completion20 Sep 2025 (estimated)
Study completion20 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Primary ImmunodeficiencyStudies of the same condition, open and under way.
More trials run by Gazi 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06092528
Sponsor's protocol ID: Gazi University 73
Status last verified: Dec 2023
First submitted: 28 Sep 2023
Last updated: 5 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180
Li AM, Yin J, Au JT, So HK, Tsang T, Wong E, Fok TF, Ng PC. Standard reference for the six-minute-walk test in healthy children aged 7 to 16 years. Am J Respir Crit Care Med. 2007 Jul 15;176(2):174-80. doi: 10.1164/rccm.200607-883OC. Epub 2007 Apr 26.
PubMed 17463419
Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017 Sep;17(8):1037-1043. doi: 10.1080/17461391.2017.1330899. Epub 2017 May 30.
PubMed 28557670
Lee JA, Laurson KR. Validity of the SenseWear armband step count measure during controlled and free-living conditions. J Exerc Sci Fit. 2015 Jun;13(1):16-23. doi: 10.1016/j.jesf.2014.11.002. Epub 2015 Jan 29.
PubMed 29541094
Patel SA, Benzo RP, Slivka WA, Sciurba FC. Activity monitoring and energy expenditure in COPD patients: a validation study. COPD. 2007 Jun;4(2):107-12. doi: 10.1080/15412550701246658.
PubMed 17530503
Ridgers ND, Hnatiuk JA, Vincent GE, Timperio A, Barnett LM, Salmon J. How many days of monitoring are needed to reliably assess SenseWear Armband outcomes in primary school-aged children? J Sci Med Sport. 2016 Dec;19(12):999-1003. doi: 10.1016/j.jsams.2016.02.009. Epub 2016 Mar 3.
PubMed 26971298
American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831
Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
PubMed 30956204
Domenech-Clar R, Lopez-Andreu JA, Compte-Torrero L, De Diego-Damia A, Macian-Gisbert V, Perpina-Tordera M, Roques-Serradilla JM. Maximal static respiratory pressures in children and adolescents. Pediatr Pulmonol. 2003 Feb;35(2):126-32. doi: 10.1002/ppul.10217.
PubMed 12526074
Woszezenki CT, Heinzmann-Filho JP, Vendrusculo FM, Piva TC, Levices I, Donadio MV. Reference Values for Inspiratory Muscle Endurance in Healthy Children and Adolescents. PLoS One. 2017 Jan 25;12(1):e0170696. doi: 10.1371/journal.pone.0170696. eCollection 2017.
PubMed 28122012
Beenakker EA, van der Hoeven JH, Fock JM, Maurits NM. Reference values of maximum isometric muscle force obtained in 270 children aged 4-16 years by hand-held dynamometry. Neuromuscul Disord. 2001 Jul;11(5):441-6. doi: 10.1016/s0960-8966(01)00193-6.
PubMed 11404114
Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.
PubMed 10024117
Uneri OS, Agaoglu B, Coskun A, Memik NC. Validity and reliability of Pediatric Quality of Life Inventory for 2- to 4-year-old and 5- to 7-year-old Turkish children. Qual Life Res. 2008 Mar;17(2):307-15. doi: 10.1007/s11136-007-9303-4. Epub 2008 Jan 18.
PubMed 18205028
Wilson RC, Jones PW. A comparison of the visual analogue scale and modified Borg scale for the measurement of dyspnoea during exercise. Clin Sci (Lond). 1989 Mar;76(3):277-82. doi: 10.1042/cs0760277.
PubMed 2924519

Want to know more?

Meral Boşnak Güçlü, Prof. Dr.

03122162647

meralbosnak@gazi.edu.tr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effects of Pulmonary Rehabilitation on Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Children With Primary Immunodeficiency
ClinicalTrials.gov ID: NCT06092528
Acronym / sponsor ID: Gazi University 73
Conditions: Primary Immunodeficiency
Keywords: primary immunodeficiency, pulmonary rehabilitation, exercise capacity, muscle oxygenation, physical activity
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Gazi UniversityUniversity, hospital or other
Study start: 1 Nov 2023 (actual)
Primary completion: 20 Sep 2025 (estimated)
Study completion: 20 Sep 2026 (estimated)
First posted: 23 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.

Detailed description

The primary aim of this study: To investigate the effects of pulmonary rehabilitation on exercise capacity and muscle oxygenation in children with primary immunodeficiency.

Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Pulmonary Rehabilitation Group	Experimental	Other: Inspiratory muscle training, Other: Upper extremity aerobic exercise training, Other: Lower extremity aerobic exercise training, Other: Resistant exercise trainingPulmonary rehabilitation practices (inspiratory muscle training, aerobic exercise training, resistance exercise training) will be performed 3 sessions a week for 6 weeks under the supervision of a physiotherapist to the training group.
Control Group	Sham comparator	Other: Thoracic expansion exercisesControl group will be given breathing exercises as a home program for 6 weeks.

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

-Patients aged 6-18 years with primary immunodeficiency

Key exclusion criteria (4 listed)

Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
Serious neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions
Participating in a planned exercise program in the past three months
Cognitive impairment, which may cause difficulty understanding and following exercise test instructions

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
Inspiratory muscle trainingInspiratory muscle training will be performed with Power Breathe®. Inspiratory muscle training will be given to the training group, starting from 50% of the MIP, and 2 sessions/day, 15 minutes/session. Patients will be asked to check breathing for 4-5 breaths after 8-10 consecutive breathing cycles. The patient will continue this cycle for 15 minutes.	Other	Pulmonary Rehabilitation Group
Upper extremity aerobic exercise trainingUpper extremity aerobic exercise training will be performed 3 days/week, 1 session/day, 15 min/session using arm ergometer device accompanied by a physiotherapist. Aerobic exercise training workload will be 60-80% of maximal heart rate. In this study, the perception of dyspnea will be between 3-4, arm fatigue and general fatigue perception will be between 5-6, warm-up and cool-down periods will be 5 minutes, and pedaling speed will be 40-50 rev/min, according to MBS.	Other	Pulmonary Rehabilitation Group
Lower extremity aerobic exercise trainingLower extremity aerobic exercise training will be performed 3 days/week, 1 session/day, 15 minutes/session using the treadmill device, accompanied by a physiotherapist. Aerobic exercise training workload was set at 60-80% of maximal heart rate, dyspnea perception according to MBS was between 3-4, arm fatigue and general fatigue perception was between 5-6, and warm-up and cool-down periods were 5 minutes.	Other	Pulmonary Rehabilitation Group
Resistant exercise trainingUpper and lower additional limb strengthening training will be performed 3 days/week, 1 session/day, 10 repetitions/sessions from the first day by using bullion weights in the presence of a physiotherapist. The upper extremity strengthening program will consist of a progressive exercise program to strengthen the shoulder flexors and abductors, and the lower extremity strengthening program to strengthen the knee extensors. The training workload will be increased progressively. For strength training, the workload will be adjusted so that the perception of fatigue is between 4 and 6 according to MBS.	Other	Pulmonary Rehabilitation Group
Thoracic expansion exercisesThe control group will be asked to do thoracic expansion exercises seven days/week and 120 pieces/day for six weeks.	Other	Control Group

Primary outcome

Oxygen Consumption
Time frame: First Day
Cardiopulmonary Exercises Test

20 secondary outcomes

Pulmonary function (Forced vital capacity (FVC))
Time frame: Second Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: Second Day
Pulmonary function (FEV1 / FVC)
Time frame: Second Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: Second Day
Pulmonary function (Peak flow rate (PEF))
Time frame: Second Day
Respiratory Muscle Strength
Time frame: Second Day
Respiratory Muscle Endurance
Time frame: Second Day
Peripheral Muscle Strength
Time frame: Second Day
Functional exercise capacity
Time frame: Second Day
Quality of Life (For Children)
Time frame: First Day
Dyspnea
Time frame: First and Second Day
Fatigue
Time frame: First and Second Day
Muscle oxygenation
Time frame: First and Second Day
Physical Activity Level (Total energy expenditure)
Time frame: Second Day
Physical activity (Active energy expenditure (joule / day))
Time frame: Second Day
Physical activity (Physical activity time (min / day))
Time frame: Second Day
Physical activity (Average metabolic equivalent (MET / day))
Time frame: Second Day
Physical activity (Number of steps (steps / day))
Time frame: Second Day
Physical activity (Time spent lying down (min / day) days))
Time frame: Second Day
Physical activity (Sleep time (min / day))
Time frame: Second Day

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
Background: PubMed 12524257American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
Background: PubMed 17463419Li AM, Yin J, Au JT, So HK, Tsang T, Wong E, Fok TF, Ng PC. Standard reference for the six-minute-walk test in healthy children aged 7 to 16 years. Am J Respir Crit Care Med. 2007 Jul 15;176(2):174-80. doi: 10.1164/rccm.200607-883OC. Epub 2007 Apr 26.
Background: PubMed 28557670Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017 Sep;17(8):1037-1043. doi: 10.1080/17461391.2017.1330899. Epub 2017 May 30.
Background: PubMed 29541094Lee JA, Laurson KR. Validity of the SenseWear armband step count measure during controlled and free-living conditions. J Exerc Sci Fit. 2015 Jun;13(1):16-23. doi: 10.1016/j.jesf.2014.11.002. Epub 2015 Jan 29.
Background: PubMed 17530503Patel SA, Benzo RP, Slivka WA, Sciurba FC. Activity monitoring and energy expenditure in COPD patients: a validation study. COPD. 2007 Jun;4(2):107-12. doi: 10.1080/15412550701246658.
Background: PubMed 26971298Ridgers ND, Hnatiuk JA, Vincent GE, Timperio A, Barnett LM, Salmon J. How many days of monitoring are needed to reliably assess SenseWear Armband outcomes in primary school-aged children? J Sci Med Sport. 2016 Dec;19(12):999-1003. doi: 10.1016/j.jsams.2016.02.009. Epub 2016 Mar 3.
Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
Background: PubMed 30956204Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
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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. This study is not recruiting at the moment.

Meral Boşnak Güçlü, Prof. Dr. contact

03122162647

meralbosnak@gazi.edu.tr

Betül Yoleri, Pt. MsC contact

betulyoleri@gazi.edu.tr

Betül Yoleri, Pt. MsC principal investigator

Gazi University

Caner Aytekin, Assoc. Prof. principal investigator

MH. Dr. Sami Ulus Children's Health and Diseases Training and Research Hospital

Meral Boşnak Güçlü, Prof. Dr. study director

Gazi University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Meral Boşnak Güçlü, Prof. Dr. (03122162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen Consumption (time frame: First Day). 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 NCT06092528, which also lists 35 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 5 Dec 2023.