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

NCT ID: NCT03832491

Last Updated: 2021-08-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-02-05

Brief Summary

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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.

Detailed Description

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Primary ciliary dyskinesia (PCD) is an autosomal recessive hereditary disorder characterized by congenital structural abnormalities and impairment of respiratory function. Mucociliary clearance is affected by disorders in the structure and movement of cilia. That causes repeated infections in the upper and lower respiratory tract.In addition to mucociliary effects and impaired lung function, it is thought that there may be a decrease in respiratory muscle strength and functional capacity. One of the factors affecting functional capacity is the level of physical activity. For these reasons, the management of the respiratory system in patients with PCD is very important. In addition to airway clearence techniques, approaches to increase physical activity are also important. It was thought that severe physical activity could be an important determinant of cardiopulmonary functional capacity in patients with mild to moderate PCD. The level of physical activity is known to be associated with quality of life.

In literature no study investigated the effects of game based approach on oxygenation, functional capacity and quality of life in patients with PCD. Game based approach is a new method lead to increase physical activity. In literature there is no study investigated the effects of game based approach on oxygenation, functional capacity and quality of life in patients with PCD.

Conditions

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Primary Ciliary Dyskinesia Kartagener Syndrome Immotile Cilia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

Home Based Therapy: 16 patients with PCD

Airway clearence techniques, everday of the week, during eight weeks

Group Type OTHER

Home based therapy

Intervention Type OTHER

Airway clearence techniques

Game and home based therapy group

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

Group Type EXPERIMENTAL

Game and home based therapy

Intervention Type OTHER

Game based approach programme and airway clearence techniques

Interventions

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Home based therapy

Airway clearence techniques

Intervention Type OTHER

Game and home based therapy

Game based approach programme and airway clearence techniques

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Hazal Sonbahar Ulu

MSc, PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hazal Sonbahar Ulu, MSc, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Deniz Inal Ince, Prof. Dr.

Role: STUDY_CHAIR

Hacettepe University

Hayriye Ugur Ozcelik, Prof. Dr.

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 35536410 (View on PubMed)

Other Identifiers

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KA-180026

Identifier Type: -

Identifier Source: org_study_id

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