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

NCT06092528 | Recruiting

• 1 other identifier: Gazi University 73
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Immunodeficiency

Keywords

primary immunodeficiency; pulmonary rehabilitation; exercise capacity; muscle oxygenation; physical activity

Outcome Measures

Primary Outcomes (1)

• Oxygen Consumption

  Cardiopulmonary Exercises Test

  First Day

Secondary Outcomes (20)

• Pulmonary function (Forced vital capacity (FVC))

  Second Day

• Pulmonary function (Forced expiratory volume in the first second (FEV1))

  Second Day

• Pulmonary function (FEV1 / FVC)

  Second Day

• Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

  Second Day

• Pulmonary function (Peak flow rate (PEF))

  Second Day

Study Arms (2)

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.

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.

Other: Thoracic expansion exercises

Interventions

Inspiratory muscle training OTHER

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.

Pulmonary Rehabilitation Group

Upper extremity aerobic exercise training OTHER

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.

Pulmonary Rehabilitation Group

Lower extremity aerobic exercise training OTHER

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.

Pulmonary Rehabilitation Group

Resistant exercise training OTHER

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.

Pulmonary Rehabilitation Group

Thoracic expansion exercises OTHER

The control group will be asked to do thoracic expansion exercises seven days/week and 120 pieces/day for six weeks.

Control Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 6-18 years with primary immunodeficiency

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Study Officials

• Betül Yoleri, Pt. MsC

  Gazi University

  PRINCIPAL INVESTIGATOR

• Caner Aytekin, Assoc. Prof.

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

  PRINCIPAL INVESTIGATOR

• Meral Boşnak Güçlü, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Meral Boşnak Güçlü, Prof. Dr.

CONTACT

03122162647; meralbosnak@gazi.edu.tr

Betül Yoleri, Pt. MsC

CONTACT

betulyoleri@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times. Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 23, 2023
• Study Start: November 1, 2023
• Primary Completion: September 20, 2025
• Study Completion (Estimated): September 20, 2026
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)