Investigation of the Effects of Pulmonary Rehabilitation in Children With Primary Immunodeficiency
NCT ID: NCT06092528
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-01
2026-09-20
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
Study Groups
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Pulmonary Rehabilitation Group
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.
Inspiratory muscle training
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 training
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 training
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 training
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.
Control Group
Control group will be given breathing exercises as a home program for 6 weeks.
Thoracic expansion exercises
The control group will be asked to do thoracic expansion exercises seven days/week and 120 pieces/day for six weeks.
Interventions
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Inspiratory muscle training
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 training
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 training
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 training
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 exercises
The control group will be asked to do thoracic expansion exercises seven days/week and 120 pieces/day for six weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
6 Years
18 Years
ALL
No
Sponsors
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Gazi University
OTHER
Responsible Party
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Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic
Principal Investigators
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Betül Yoleri, Pt. MsC
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Caner Aytekin, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
MH. Dr. Sami Ulus Children's Health and Diseases Training and Research Hospital
Meral Boşnak Güçlü, Prof. Dr.
Role: STUDY_DIRECTOR
Gazi University
Locations
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Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Meral BOŞNAK GÜÇLÜ, Prof.Dr.
Role: primary
Betül Yoleri, Pt. MsC
Role: backup
References
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Other Identifiers
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Gazi University 73
Identifier Type: -
Identifier Source: org_study_id