Evaluation of Adult Patients With Immunodeficiency Within the Scope of the ICF

NCT06014463 | Completed

• 1 other identifier: GO 23/16
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Primary immunodeficiency is a clinically, immunologically, and genetically heterogeneous group of diseases that occur as a result of quantitative and/or qualitative deficiency of one or more cellular and molecular components belonging to the immune system. This classification, called the International Classification of Functioning, Disability and Health ( ICF), constitutes a common language and perspective for the definition of health and health-related conditions. This study aimed to evaluate the body structure function, activity and participation limitations of adult immunodeficiency patients within the scope of ICF and to compare body structure function, activity and participation limitations and compare with healthy people.

Conditions

Primary Immune Deficiency; Exercise Capacity; Physical Activity; Quality of Life

Keywords

Primary Immune Deficiency; ICF; Functional Performance

Outcome Measures

Primary Outcomes (1)

• Evaluation of hand grip strength

  The participants will be measured in an unsupported sitting position with his back upright, while the elbow is in flexion (the person's arm is adjacent to the torso, in a neutral position, and the elbow is in a 90° flexion, with the wrist neutral). The measurements for the dominant and non-dominant sides will be repeated three times. The average of the three measurements for each side will be taken and recorded in Newton (N).

  1 day

Secondary Outcomes (10)

• Evaluation of body composition:

  1 day

• Comorbidity Assessment

  1 day

• Evaluation of Sleep Quality

  1 day

• Fatigue Assessment

  1 day

• Posture Evaluation

  1 day

Study Arms (2)

Patients with Primary Immune Deficiency

Patients between the ages of 18-65 years who have been diagnosed with primary immunodeficiency

Healthy Controls

Age and sex matched healthy controls between the ages of 18-65 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients between the ages of 18-65 who have been diagnosed with immunodeficiency at Başkent University Hospital Immunology Department and Gülhane Hospital Immunology Department and who are willing to participate in the research and 18-65 patients who are diagnosed with immunodeficiency will be accepted for the study. The snowball sampling method will be used for our control group. We plan to contact the patient's relatives and then contact someone else in the same way. At the same time, we plan to prepare a text explaining each method and reach people through social media.

Criteria for Inclusion in the Adult Immunodeficiency Group 1. to be between the ages of 18-65 years old. 2. to be volunteer to participate in research 3. to have been diagnosed with Primary Immunodeficiency 4. to be taking immunoglobulin replacement therapy 5. to have no problems in reading and/or understanding scales and being able to cooperate with tests Criteria for exclusion of the Adult Immunodeficiency Group: 1. The presence of active infection 2. Musculoskeletal and neurological disease that may affect exercise performance symptomatic heart disease 3. To have a neurological disease or other clinical diagnosis that may affect cognitive status Criteria for inclusion in the control group: 1. to be between the ages of 18-65 years old 2. to give informed consent 3. to have no problems in reading and/or understanding scales and being able to cooperate with tests Criteria for exclusion of the Control Group: 1. to have any orthopedic or neuromuscular disorder that will interfere with walking or exercise performance, 2. to have any chronic disease or to have psychiatric disorders or mental influences that may prevent cooperation or compliance with exercise tests.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hacettepe University: lead
• Baskent University: collaborator

Study Sites (1)

Ebru Çalık Kutukcu

Ankara, Hacettepe Unıversity, 06100, Turkey (Türkiye)

Location

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

• Ebru Calik-Kutukcu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 28, 2023
• Study Start: March 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)