Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia

NCT03832491 | Completed DMC

• 1 other identifier: KA-180026
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Impaired pulmonary function, decreased physical activity, functional capacity and depending on these factors are reported in patients with primary ciliary dyskinesia in recent studies. The purpose of this study to evaluate the effects of game based approach on pulmonary function, functional capacity and quality of life in patients with primary ciliary dykinesia.

Conditions

Primary Ciliary Dyskinesia; Kartagener Syndrome; Immotile Cilia Syndrome

Keywords

Primary Ciliary Dyskinesia; Kartegener Syndrome; Immotile Cilia Syndrome; Pulmonary Rehabilitation; Airway Clearance Techniques; Exergame

Outcome Measures

Primary Outcomes (2)

• Functional capacity using six minute walk test

  Six minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions.

  Change from baseline distance of six minute walk test in 8 weeks

• Distance of six minute walk test

  The distance walked will be recorded as meters at the end of 6 minute walk test.

  Change from baseline distance of six minute walk test in 8 weeks

Secondary Outcomes (28)

• Demographic features-Age

  Before and after 8 weeks

• Demographic features-Weight

  Before and after 8 weeks

• Demographic features-Lenght

  Before and after 8 weeks

• Demographic features-Body Mass Index

  Before and after 8 weeks

• Vital Signs-Heart Rate

  Before and after 8 weeks

Study Arms (2)

Control Group

OTHER

Home Based Therapy: 16 patients with PCD Airway clearence techniques, everday of the week, during eight weeks

Other: Home based therapy

Game and home based therapy group

EXPERIMENTAL

Game based approach programme: 16 patients with PCD Game based approach programme will be done using the exergame with the game console, fourty minutes three times per week for eight weeks. Exergame includes five games selected from two kinects games CD. Each game will be played for five games set. Airway clearence techniques, everday of the week, during eight weeks

Other: Game and home based therapy

Interventions

Home based therapy OTHER

Airway clearence techniques

Control Group

Game and home based therapy OTHER

Game based approach programme and airway clearence techniques

Game and home based therapy 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:

• Being diagnosed with PCD
• Being clinically stable
• Between 6-18 years old
• Volunteer to participate in research

You may not qualify if:

• Not having a stable clinical condition
• Patients with severe neuromuscular, musculoskeletal and rheumatological problems
• Patients with loss of balance
• Not being cooperative

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Sonbahar-Ulu H, Inal-Ince D, Saglam M, Cakmak A, Vardar-Yagli N, Calik-Kutukcu E, Sumer E, Ozcelik U. Active video gaming in primary ciliary dyskinesia: a randomized controlled trial. Eur J Pediatr. 2022 Aug;181(8):2891-2900. doi: 10.1007/s00431-022-04490-z. Epub 2022 May 10.

  PMID: 35536410 DERIVED

MeSH Terms

Conditions

Ciliary Motility Disorders; Kartagener Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Bronchiectasis; Bronchial Diseases; Respiratory System Abnormalities; Dextrocardia; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Situs Inversus

Study Officials

• Hazal Sonbahar Ulu, MSc, PT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Deniz Inal Ince, Prof. Dr.

  Hacettepe University

  STUDY CHAIR

• Hayriye Ugur Ozcelik, Prof. Dr.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PT

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: February 6, 2019
• Study Start: May 20, 2019
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)