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

Primary Purpose

Primary Ciliary Dyskinesia, Kartagener Syndrome, Immotile Cilia Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home based therapy
Game and home based therapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Ciliary Dyskinesia focused on measuring Primary Ciliary Dyskinesia, Kartegener Syndrome, Immotile Cilia Syndrome, Pulmonary Rehabilitation, Airway Clearance Techniques, Exergame

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control Group

Game and home based therapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Demographic features-Age
The age will be recorded in years.
Demographic features-Weight
Weight will be recorded in kilograms.
Demographic features-Lenght
The length will be saved in meters.
Demographic features-Body Mass Index
Body mass index will be calculated by dividing the weight by the square of the height (kg/m^2).
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.
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.
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.
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.
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.
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.
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.
Pulmonary function
Pulmonary function assessed by the spirometer
Respiratory muscle strength
Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.
Peripheral muscle strength
Peripheral muscle strength will be assessed by the hand held dynamometer.
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.
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.
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.
Extending distance in Y Balance Test
Extending distance will be recorded as centimeter (cm).
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.
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.
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).
Energy expenditure while playing seated games.
Energy expenditure will be evaluated by Sense Wear Armband while playing seated games.
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.
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.
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.
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.
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
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.

Full Information

First Posted
January 1, 2019
Last Updated
August 17, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03832491
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ciliary Dyskinesia, Kartagener Syndrome, Immotile Cilia Syndrome
Keywords
Primary Ciliary Dyskinesia, Kartegener Syndrome, Immotile Cilia Syndrome, Pulmonary Rehabilitation, Airway Clearance Techniques, Exergame

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
Home Based Therapy: 16 patients with PCD Airway clearence techniques, everday of the week, during eight weeks
Arm Title
Game and home based therapy group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Home based therapy
Intervention Description
Airway clearence techniques
Intervention Type
Other
Intervention Name(s)
Game and home based therapy
Intervention Description
Game based approach programme and airway clearence techniques
Primary Outcome Measure Information:
Title
Functional capacity using six minute walk test
Description
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.
Time Frame
Change from baseline distance of six minute walk test in 8 weeks
Title
Distance of six minute walk test
Description
The distance walked will be recorded as meters at the end of 6 minute walk test.
Time Frame
Change from baseline distance of six minute walk test in 8 weeks
Secondary Outcome Measure Information:
Title
Demographic features-Age
Description
The age will be recorded in years.
Time Frame
Before and after 8 weeks
Title
Demographic features-Weight
Description
Weight will be recorded in kilograms.
Time Frame
Before and after 8 weeks
Title
Demographic features-Lenght
Description
The length will be saved in meters.
Time Frame
Before and after 8 weeks
Title
Demographic features-Body Mass Index
Description
Body mass index will be calculated by dividing the weight by the square of the height (kg/m^2).
Time Frame
Before and after 8 weeks
Title
Vital Signs-Heart Rate
Description
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.
Time Frame
Before and after 8 weeks
Title
Vital Signs-Systolic Blood Pressure
Description
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.
Time Frame
Before and after 8 weeks
Title
Vital Signs-Diastolic Blood Pressure
Description
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.
Time Frame
Before and after 8 weeks
Title
Vital Signs-Respiratory Rate
Description
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.
Time Frame
Before and after 8 weeks
Title
Vital Signs-Perception of dyspnea
Description
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.
Time Frame
Before and after 8 weeks
Title
Perception of general fatigue
Description
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.
Time Frame
Before and after 8 weeks
Title
Perception of quadriceps fatigue
Description
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.
Time Frame
Before and after 8 weeks
Title
Pulmonary function
Description
Pulmonary function assessed by the spirometer
Time Frame
Before and after 8 weeks
Title
Respiratory muscle strength
Description
Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.
Time Frame
Before and after 8 weeks
Title
Peripheral muscle strength
Description
Peripheral muscle strength will be assessed by the hand held dynamometer.
Time Frame
Before and after 8 weeks
Title
Statical Balance
Description
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.
Time Frame
Before and after 8 weeks
Title
Loss of balance of Flamingo Balance Test
Description
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.
Time Frame
Before and after 8 weeks
Title
Dynamic Balance
Description
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.
Time Frame
Before and after 8 weeks
Title
Extending distance in Y Balance Test
Description
Extending distance will be recorded as centimeter (cm).
Time Frame
Before and after 8 weeks
Title
Subjective Physical Activity
Description
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.
Time Frame
Before and after 8 weeks
Title
Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare
Description
The average energy calculation in kilocalories per kilogram at intervals of fifteen minutes is used to calculate daily energy consumption.
Time Frame
Before and after 8 weeks
Title
Objective Physical Activity
Description
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).
Time Frame
Before and after 8 weeks
Title
Energy expenditure while playing seated games.
Description
Energy expenditure will be evaluated by Sense Wear Armband while playing seated games.
Time Frame
Before and after 8 weeks
Title
Energy expenditure while playing each kinect games.
Description
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.
Time Frame
Week one and half
Title
Activity of Daily Living
Description
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.
Time Frame
Before and after 8 weeks
Title
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.
Description
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.
Time Frame
Before and after 8 weeks
Title
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.
Description
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.
Time Frame
Before and after 8 weeks
Title
Exercise capacity using incremental shuttle walk test.
Description
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
Time Frame
Before and after 8 weeks
Title
Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2)
Description
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.
Time Frame
Before and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazal Sonbahar Ulu, MSc, PT
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deniz Inal Ince, Prof. Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hayriye Ugur Ozcelik, Prof. Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35536410
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.
Results Reference
derived

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

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