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

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.

Study Overview

• Status: Completed
• Conditions: Primary Ciliary Dyskinesia; Kartagener Syndrome; Immotile Cilia Syndrome
• Intervention / Treatment: Other: Home based therapy; Other: Game and home based therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; Home Based Therapy: 16 patients with PCD Airway clearence techniques, everday of the week, during eight weeks	Other: Home based therapy; Airway clearence techniques
Experimental: 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	Other: Game and home based therapy; Game based approach programme and airway clearence techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic features-Age	The age will be recorded in years.	Before and after 8 weeks
Demographic features-Weight	Weight will be recorded in kilograms.	Before and after 8 weeks
Demographic features-Lenght	The length will be saved in meters.	Before and after 8 weeks
Demographic features-Body Mass Index	Body mass index will be calculated by dividing the weight by the square of the height (kg/m^2).	Before and after 8 weeks
Vital Signs-Heart Rate	Heart rate will be recorded before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated game and kinect games. The number of heart beats per minute will be evaluated before and after the tests to measure how much it has changed in 8 weeks.	Before and after 8 weeks
Vital Signs-Systolic Blood Pressure	Systolic blood pressure will be measued before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The systolic blood pressure will be evaluated before and after the tests to measure how much it has changed in 8 weeks.	Before and after 8 weeks
Vital Signs-Diastolic Blood Pressure	Diastolic blood pressure will be measued before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The diastolic blood pressure will be evaluated before and after the tests to measure how much it has changed in 8 weeks.	Before and after 8 weeks
Vital Signs-Respiratory Rate	Respiratory rate will be recorded before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The respiratory rate will be evaluated before and after the tests to measure how much it has changed in 8 weeks.	Before and after 8 weeks
Vital Signs-Perception of dyspnea	Perception of dyspnea will be evaluated by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. OMNI is a perceived exertion scale as BORG perceived exertion scale. The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of dyspnea will be evaluated before and after the tests to measure how much it has changed in 8 weeks.	Before and after 8 weeks
Perception of general fatigue	Perception of fatigue will be assessed by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games.OMNI is a perceived exertion scale as BORG perceived exertion scale.The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of general fatigue will be evaluated before and after the tests to measure how much it has changed in 8 weeks.	Before and after 8 weeks
Perception of quadriceps fatigue	Perception of quadriceps fatigue will be assessed by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test,playing seated games and kinect games. OMNI scale is a perceived exertion scale as BORG scale. The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of quadriceps fatigue will be evaluated before and after the tests to measure how much it has changed in 8 weeks.	Before and after 8 weeks
Pulmonary function	Pulmonary function assessed by the spirometer	Before and after 8 weeks
Respiratory muscle strength	Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.	Before and after 8 weeks
Peripheral muscle strength	Peripheral muscle strength will be assessed by the hand held dynamometer.	Before and after 8 weeks
Statical Balance	Statical balance will ve assessed by the flamingo balance test. The test evaluates the postural balance.In this test, a metal or wooden beam with a length of 50 cm, a height of 4 cm and a width of 3 cm is used. During this test, the participant tries to stand with a single foot in a manner similar to the flamingo position for as long as possible on the long axis of the beam. The stopwatch starts with the command. When the balance is distorted, the time is stopped and the time progresses until the next equilibrium loss.	Before and after 8 weeks
Loss of balance of Flamingo Balance Test	Balance disturbances within 1 min are counted. If there is more than 15 loss of balance within the first 30s, the test is terminated and zero score is given.	Before and after 8 weeks
Dynamic Balance	Dynamic balance will be evaluated by the Y balance test. The test extends to the directions determined by the lower limb of the participant and assesses the stability and stability of the participant on the other.In the test setup, 3 pieces of tape measure will be glued to the floor in an angle of 120 degrees. At the intersection of these 3 scales, one will be asked to stand on one foot with the other foot in 3 directions as anterior, posteromedial and posterolateral. At this time, the participant's balance, not to stand on the foot of the heel of the feet to stand up and extend the finger tips of the feet will be careful to touch slightly. At the end of each test, the participant will be asked to bring his foot to the side of his foot without losing the balance and touching the floor. This application will be repeated 3 times for each test.	Before and after 8 weeks
Extending distance in Y Balance Test	Extending distance will be recorded as centimeter (cm).	Before and after 8 weeks
Subjective Physical Activity	Subjective physical activity will ve assessed by the Bouchard Three-Day Physical Activity Questionnaire. It queries the individual's level of physical activity on weekdays and at the weekend.	Before and after 8 weeks
Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare	The average energy calculation in kilocalories per kilogram at intervals of fifteen minutes is used to calculate daily energy consumption.	Before and after 8 weeks
Objective Physical Activity	The objective physical activity will be evaluated by the SenseWear Armband which has three-axis accelerometer sensors during the Glittre Activity of Daily Living Test. Energy consumption will be calculated as metabolic equivalent of task (MET).	Before and after 8 weeks
Energy expenditure while playing seated games.	Energy expenditure will be evaluated by Sense Wear Armband while playing seated games.	Before and after 8 weeks
Energy expenditure while playing each kinect games.	Energy expenditure will be assessed by Sense Wear Armband before starting to play each kinect games to determine how much energy consumption level of the games has reached during the session.	Week one and half
Activity of Daily Living	Activity of daily living will ve evaluated by the Glittre Activity of DailyLiving (ADL) test. Glittre ADL test is a test that provides standardized functional status assessment including activities similar to daily living activities.	Before and after 8 weeks
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.	1. The device is a portable NIRS LED device used to determine lactate level during the movement. BSX is housed in a compression sleeve and fitted over the gastrocnemius muscle.	Before and after 8 weeks
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.	1. The device is a portable NIRS LED device used to determine lactate level during the movement. BSX is housed in a compression sleeve and fitted over the gastrocnemius muscle.	Before and after 8 weeks
Exercise capacity using incremental shuttle walk test.	Incremental shuttle walk test will be performed in a enclosed corridor. Patients are required to turn around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients will follow the rhythm dictated by the audio signal	Before and after 8 weeks
Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2)	The Turkish version of QOL-PCD will be used. The questionnare evaluate physical, social and emotional status in different age groups (pediatrics, adolescents, adults and parents).The total numbers of items in the questionnaires are 35 questions for parents' , 32 questions for children, 38 questions for adolescents, 40 questions for adults.	Before and after 8 weeks

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Hazal Sonbahar Ulu, MSc, PT, Hacettepe University; Study Chair: Deniz Inal Ince, Prof. Dr., Hacettepe University; Study Director: Hayriye Ugur Ozcelik, Prof. Dr., Hacettepe University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation; Primary Ciliary Dyskinesia; Kartegener Syndrome; Immotile Cilia Syndrome; Airway Clearance Techniques; Exergame
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Disease; Congenital Abnormalities; Bronchial Diseases; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Movement Disorders; Heart Defects, Congenital; Cardiovascular Abnormalities; Abnormalities, Multiple; Ciliopathies; Bronchiectasis; Respiratory System Abnormalities; Dextrocardia; Situs Inversus; Syndrome; Dyskinesias; Ciliary Motility Disorders; Kartagener Syndrome
• Other Study ID Numbers: KA-180026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No