Primary Ciliary DyskinesiaNCT03832491
Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia
A study testing Home based therapy and Game and home based therapy in people with Primary Ciliary Dyskinesia and Kartagener Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Primary Ciliary Dyskinesia, Kartagener Syndrome, Immotile Cilia Syndrome
- What is being tested?
- Home based therapy and Game and home based therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2019to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being diagnosed with PCD
- Being clinically stable
- Between 6-18 years old
- Volunteer to participate in research
Who cannot join
- Not having a stable clinical condition
- Patients with severe neuromuscular, musculoskeletal and rheumatological problems
- Patients with loss of balance
- Not being cooperative
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, 06100
About this study
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.
Read the 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.
- Being tested
- Home based therapy, Game and home based therapy
- Keywords
- Primary Ciliary Dyskinesia, Kartegener Syndrome, Immotile Cilia Syndrome, Pulmonary Rehabilitation, Airway Clearance Techniques, Exergame
- Medical subject headings
- Ciliary Motility Disorders, Kartagener Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based therapyOther
Airway clearence techniques
Game and home based therapyOther
Game based approach programme and airway clearence techniques
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Home Based Therapy: 16 patients with PCD
Airway clearence techniques, everday of the week, during eight weeks Receives: 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 Receives: Other: Game and home based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline distance of six minute walk test in 8 weeks
Secondary outcomes (28)
Demographic features-Age
The age will be recorded in years.
Measured: Before and after 8 weeks
Demographic features-Weight
Weight will be recorded in kilograms.
Measured: Before and after 8 weeks
Demographic features-Lenght
The length will be saved in meters.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after 8 weeks
Pulmonary function
Pulmonary function assessed by the spirometer
Measured: Before and after 8 weeks
Respiratory muscle strength
Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.
Measured: Before and after 8 weeks
Peripheral muscle strength
Peripheral muscle strength will be assessed by the hand held dynamometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after 8 weeks
Extending distance in Y Balance Test
Extending distance will be recorded as centimeter (cm).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Before and after 8 weeks
Energy expenditure while playing seated games.
Energy expenditure will be evaluated by Sense Wear Armband while playing seated games.
Measured: 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.
Measured: 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.
Measured: Before and after 8 weeks
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.
- 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.
Measured: Before and after 8 weeks
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.
- 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.
Measured: 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
Measured: 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.
Measured: Before and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start20 May 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal Sonbahar Ulu, Hacettepe University
- Investigators
- Hazal Sonbahar Ulu, MSc, PT, Principal investigator, Hacettepe UniversityDeniz Inal Ince, Prof. Dr., Study chair, Hacettepe UniversityHayriye Ugur Ozcelik, Prof. Dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832491
- Sponsor's protocol ID
- KA-180026
- Status last verified
- Aug 2021
- First submitted
- 1 Jan 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35536410
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia
- ClinicalTrials.gov ID
- NCT03832491
- Acronym / sponsor ID
- KA-180026
- Keywords
- Primary Ciliary Dyskinesia, Kartegener Syndrome, Immotile Cilia Syndrome, Pulmonary Rehabilitation, Airway Clearance Techniques, Exergame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Home based therapyHome Based Therapy: 16 patients with PCD Airway clearence techniques, everday of the week, during eight weeks |
| Game and home based therapy group | Experimental | Other: Game and home based therapyGame 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being diagnosed with PCD
- Being clinically stable
- Between 6-18 years old
- Volunteer to participate in research
Key exclusion criteria (4 listed)
- Not having a stable clinical condition
- Patients with severe neuromuscular, musculoskeletal and rheumatological problems
- Patients with loss of balance
- Not being cooperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based therapyAirway clearence techniques | Other | Control Group |
| Game and home based therapyGame based approach programme and airway clearence techniques | Other | Game and home based therapy group |
Primary outcome
Functional capacity using six minute walk test
Time frame: Change from baseline distance of six minute walk test in 8 weeks
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
Time frame: Change from baseline distance of six minute walk test in 8 weeks
The distance walked will be recorded as meters at the end of 6 minute walk test.
28 secondary outcomes
Demographic features-Age
Time frame: Before and after 8 weeks
Demographic features-Weight
Time frame: Before and after 8 weeks
Demographic features-Lenght
Time frame: Before and after 8 weeks
Demographic features-Body Mass Index
Time frame: Before and after 8 weeks
Vital Signs-Heart Rate
Time frame: Before and after 8 weeks
Vital Signs-Systolic Blood Pressure
Time frame: Before and after 8 weeks
Vital Signs-Diastolic Blood Pressure
Time frame: Before and after 8 weeks
Vital Signs-Respiratory Rate
Time frame: Before and after 8 weeks
Vital Signs-Perception of dyspnea
Time frame: Before and after 8 weeks
Perception of general fatigue
Time frame: Before and after 8 weeks
Perception of quadriceps fatigue
Time frame: Before and after 8 weeks
Pulmonary function
Time frame: Before and after 8 weeks
Respiratory muscle strength
Time frame: Before and after 8 weeks
Peripheral muscle strength
Time frame: Before and after 8 weeks
Statical Balance
Time frame: Before and after 8 weeks
Loss of balance of Flamingo Balance Test
Time frame: Before and after 8 weeks
Dynamic Balance
Time frame: Before and after 8 weeks
Extending distance in Y Balance Test
Time frame: Before and after 8 weeks
Subjective Physical Activity
Time frame: Before and after 8 weeks
Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare
Time frame: Before and after 8 weeks
Objective Physical Activity
Time frame: Before and after 8 weeks
Energy expenditure while playing seated games.
Time frame: Before and after 8 weeks
Energy expenditure while playing each kinect games.
Time frame: Week one and half
Activity of Daily Living
Time frame: Before and after 8 weeks
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.
Time frame: Before and after 8 weeks
Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.
Time frame: Before and after 8 weeks
Exercise capacity using incremental shuttle walk test.
Time frame: Before and after 8 weeks
Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2)
Time frame: Before and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 35536410Sonbahar-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.
- Individual participant dataSharing planned: No
Related trials for Primary Ciliary Dyskinesia
RecruitingObservational study
Utility of PCD Diagnostics to Improve Clinical Care
Primary Ciliary Dyskinesia
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Recruiting
Primary Ciliary Dyskinesia in Adult Bronchiectasis
Idiopathic Bronchiectasis
Not yet recruitingObservational study
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
Primary Ciliary Dyskinesia (PCD)
Not yet recruitingObservational study
Malnutrition and Sarcopenia Among Primary Ciliary Dyskinesia
Primary Ciliary Dyskinesia (PCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazal Sonbahar Ulu, MSc, PT principal investigator
Hacettepe University
Deniz Inal Ince, Prof. Dr. study chair
Hacettepe University
Hayriye Ugur Ozcelik, Prof. Dr. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based therapy and Game and home based therapy in people with Primary Ciliary Dyskinesia and Kartagener Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity using six minute walk test (time frame: Change from baseline distance of six minute walk test in 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.