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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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ClinicalTrials.gov Identifier: NCT03832491
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hazal Sonbahar Ulu, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Primary Ciliary Dyskinesia Kartagener Syndrome Immotile Cilia Syndrome Other: Home based therapy Other: Game and home based therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : March 15, 2020


Arm Intervention/treatment
Control Group

Home Based Therapy: 13 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: 13 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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Demographic features-Age [ Time Frame: Before and after 8 weeks ]
    The age will be recorded in years.

  2. Demographic features-Weight [ Time Frame: Before and after 8 weeks ]
    Weight will be recorded in kilograms.

  3. Demographic features-Lenght [ Time Frame: Before and after 8 weeks ]
    The length will be saved in meters.

  4. Demographic features-Body Mass Index [ Time Frame: Before and after 8 weeks ]
    Body mass index will be calculated by dividing the weight by the square of the height (kg/m^2).

  5. Vital Signs-Heart Rate [ Time Frame: Before and after 8 weeks ]
    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.

  6. Vital Signs-Systolic Blood Pressure [ Time Frame: Before and after 8 weeks ]
    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.

  7. Vital Signs-Diastolic Blood Pressure [ Time Frame: Before and after 8 weeks ]
    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.

  8. Vital Signs-Respiratory Rate [ Time Frame: Before and after 8 weeks ]
    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.

  9. Vital Signs-Perception of dyspnea [ Time Frame: Before and after 8 weeks ]
    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.

  10. Perception of general fatigue [ Time Frame: Before and after 8 weeks ]
    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.

  11. Perception of quadriceps fatigue [ Time Frame: Before and after 8 weeks ]
    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.

  12. Pulmonary function [ Time Frame: Before and after 8 weeks ]
    Pulmonary function assessed by the spirometer

  13. Respiratory muscle strength [ Time Frame: Before and after 8 weeks ]
    Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.

  14. Peripheral muscle strength [ Time Frame: Before and after 8 weeks ]
    Peripheral muscle strength will be assessed by the hand held dynamometer.

  15. Statical Balance [ Time Frame: Before and after 8 weeks ]
    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.

  16. Loss of balance of Flamingo Balance Test [ Time Frame: Before and after 8 weeks ]
    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.

  17. Dynamic Balance [ Time Frame: Before and after 8 weeks ]
    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.

  18. Extending distance in Y Balance Test [ Time Frame: Before and after 8 weeks ]
    Extending distance will be recorded as centimeter (cm).

  19. Subjective Physical Activity [ Time Frame: Before and after 8 weeks ]
    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.

  20. Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare [ Time Frame: Before and after 8 weeks ]
    The average energy calculation in kilocalories per kilogram at intervals of fifteen minutes is used to calculate daily energy consumption.

  21. Objective Physical Activity [ Time Frame: Before and after 8 weeks ]
    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).

  22. Energy expenditure while playing seated games. [ Time Frame: Before and after 8 weeks ]
    Energy expenditure will be evaluated by Sense Wear Armband while playing seated games.

  23. Energy expenditure while playing each kinect games. [ Time Frame: Week one and half ]
    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.

  24. Activity of Daily Living [ Time Frame: Before and after 8 weeks ]
    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.

  25. Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test. [ Time Frame: Before and after 8 weeks ]
    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.

  26. Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test. [ Time Frame: Before and after 8 weeks ]
    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.

  27. Exercise capacity using incremental shuttle walk test. [ Time Frame: Before and after 8 weeks ]
    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

  28. Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2) [ Time Frame: Before and after 8 weeks ]
    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.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832491


Contacts
Contact: Hazal Sonbahar Ulu, MSc, PT +9003123052525 ext 178 FztHazal@gmail.com
Contact: Deniz Inal Ince, Prof. Dr. +9003123052525 ext 178 dinalince@yahoo.com

Locations
Turkey
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Not yet recruiting
Ankara, Turkey, 06100
Contact: Hazal Sonbahar Ulu, MSc, PT    +9003123052525 ext 178    FztHazal@gmail.com   
Contact: Deniz Inal Ince, Prof. Dr.    +9003123052525 ext 178    dinalince@yahoo.com   
Principal Investigator: Hazal Sonbahar Ulu, MSc, PT         
Sponsors and Collaborators
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

Responsible Party: Hazal Sonbahar Ulu, MSc, PT, Hacettepe University
ClinicalTrials.gov Identifier: NCT03832491     History of Changes
Other Study ID Numbers: KA-180026
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: When we finish the study, all results will be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hazal Sonbahar Ulu, Hacettepe University:
Primary Ciliary Dyskinesia
Kartegener Syndrome
Immotile Cilia Syndrome
Pulmonary Rehabilitation
Airway Clearance Techniques
Exergame

Additional relevant MeSH terms:
Bronchiectasis
Syndrome
Dyskinesias
Ciliary Motility Disorders
Kartagener Syndrome
Disease
Pathologic Processes
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Bronchial Diseases
Respiratory System Abnormalities
Dextrocardia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Situs Inversus