Clinical trial NCT03832491: Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia
Official title: Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Ciliary Dyskinesia
Kartagener Syndrome
Immotile Cilia Syndrome
Keywords: Primary Ciliary Dyskinesia
Kartegener Syndrome
Immotile Cilia Syndrome
Pulmonary Rehabilitation
Airway Clearance Techniques
Exergame
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional capacity using six minute walk test
timeFrame: Change from baseline distance of six minute walk test in 8 weeks
measure: Distance of six minute walk test
timeFrame: Change from baseline distance of six minute walk test in 8 weeks
Secondary outcomes:
measure: Demographic features-Age
timeFrame: Before and after 8 weeks
measure: Demographic features-Weight
timeFrame: Before and after 8 weeks
measure: Demographic features-Lenght
timeFrame: Before and after 8 weeks
measure: Demographic features-Body Mass Index
timeFrame: Before and after 8 weeks
measure: Vital Signs-Heart Rate
timeFrame: Before and after 8 weeks
measure: Vital Signs-Systolic Blood Pressure
timeFrame: Before and after 8 weeks
measure: Vital Signs-Diastolic Blood Pressure
timeFrame: Before and after 8 weeks
measure: Vital Signs-Respiratory Rate
timeFrame: Before and after 8 weeks
measure: Vital Signs-Perception of dyspnea
timeFrame: Before and after 8 weeks
measure: Perception of general fatigue
timeFrame: Before and after 8 weeks
measure: Perception of quadriceps fatigue
timeFrame: Before and after 8 weeks
measure: Pulmonary function
timeFrame: Before and after 8 weeks
measure: Respiratory muscle strength
timeFrame: Before and after 8 weeks
measure: Peripheral muscle strength
timeFrame: Before and after 8 weeks
measure: Statical Balance
timeFrame: Before and after 8 weeks
measure: Loss of balance of Flamingo Balance Test
timeFrame: Before and after 8 weeks
measure: Dynamic Balance
timeFrame: Before and after 8 weeks
measure: Extending distance in Y Balance Test
timeFrame: Before and after 8 weeks
measure: Subjective Physical Activity
timeFrame: Before and after 8 weeks
measure: Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare
timeFrame: Before and after 8 weeks
measure: Objective Physical Activity
timeFrame: Before and after 8 weeks
measure: Energy expenditure while playing seated games.
timeFrame: Before and after 8 weeks
measure: Energy expenditure while playing each kinect games.
timeFrame: Week one and half
measure: Activity of Daily Living
timeFrame: Before and after 8 weeks
measure: Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.
timeFrame: Before and after 8 weeks
measure: Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.
timeFrame: Before and after 8 weeks
measure: Exercise capacity using incremental shuttle walk test.
timeFrame: Before and after 8 weeks
measure: Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2)
timeFrame: Before and after 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Hazal Sonbahar Ulu, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Deniz Inal Ince, Prof. Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Hayriye Ugur Ozcelik, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.