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Efficacy of Video-Based Interactive Game Therapy in Interstitial Lung Patients

Primary Purpose

Interstitial Lung Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Lung Disease focused on measuring Video-based game therapy, Aerobic Exercise

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by a chest diseases specialist, aged between 40-65 years, and have been under follow-up for at least 6 months according to the current ATS/ERS guidelines. Clinically stable, with no exacerbations or infections. Able to walk, with no visual or auditory impairments. Patients with cognitive abilities sufficient to understand commands. Exclusion Criteria: Orthopedic and neurological problems that could hinder exercise training. Changes in medical treatment during the study. Unstable cardiac diseases. Insufficient cooperation. Diagnosed visual, auditory, vestibular, or neurological problems that could affect balance.

Sites / Locations

  • İstanbul Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

No Intervention

Arm Label

Aerobic Exercise

Nintendo +aerobic exercise

Control

Arm Description

Patients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 20-30 minutes, accompanied by a physiotherapist.

Nintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 20 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 40 minutes.

Physical activity recommendation and respiratory exercises

Outcomes

Primary Outcome Measures

6 minute walk test
6 minute walk test:Used to determine submaximal functional exercise capacity. Patients are asked to walk as far as possible in a 30-meter straight corridor at their own walking pace for six minutes. The patient rests in a sitting position for 10 minutes in the corridor before starting the test. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The distance walked in six minutes is recorded.
Incremental Shuttle Walk Test
Incremental Shuttle Walk Test (ISWT): Used to determine functional exercise capacity. Patients walk around a cassette with signals previously recorded at a rate of 0.17 m/s, which increases every minute, starting at a pace of 10 meters per minute. The test consists of a maximum of 12 stages. The test is terminated if the patient cannot complete it within the allowed time (if the patient is more than 0.5 meters away from the signal cone when the signal sounds) or if the patient reaches 85% of the predicted maximum heart rate calculated according to the formula [210 - (0.65 x age)]. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking distance is recorded.
Endurance Shuttle Walk Test
Endurance Shuttle Walk Test (ESWT): Endurance capacity is determined using ESWT. The walking speed (workload) to be used in ESWT will be calculated as 85% of the maximum sustainable speed obtained from ISWT. Patients are asked to warm up by walking at a slower pace for two minutes and then to walk at a steady pace. The test is terminated if the patient feels too breathless to continue walking, becomes fatigued, or completes the 20-minute test duration. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking time is recorded in seconds.

Secondary Outcome Measures

Respiratory Muscle Strength
Measurement of respiratory muscle strength will be performed using an electronic mouth pressure measurement device, the "MicroRPM" brand (Micro Medical; UK), in accordance with ATS and ERS criteria.
Muscle strength
Quadriceps Function Assessment;Quadriceps muscle strength will be evaluated using a hand-held dynamometer (J-Tech CommanderTM Muscle Tester, USA) by performing maximal voluntary isometric contractions (break test).
Dyspnea
The Modified Medical Research Council Scale is used to assess the level of dyspnea experienced in daily life.The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 4 (normal) to Grade 0 (no visible contraction).
Fatigue
A 9-item Fatigue Severity Scale is created by selecting fatigue-related characteristics. Each question is rated on a scale of 1-7, with 1 indicating no effect and 7 indicating a high impact. The total score is calculated as the sum or average of all responses.
Patient Satisfaction
The Global Change Scale is used to assess the perceived effect of the treatment on the patient's current health condition.In most cases, a 5 or 6 item Likert scale is used ranging from 0 = Fail; 1 = Borderline; 2 = Pass; 3 = Good to 4 = Excellent.
The Saint George Respiratory Questionnaire
The Saint George Respiratory Questionnaire (SGRQ) is used to assess health-related quality of life. It consists of 50 questions and three subscales: symptoms, activity, and impact.Scores range from 0 to 100, with higher scores indicating more limitations.
Daily Life Activities:
The London Chest Activity of Daily Living Scale (LCADL) is used to assess daily life activities and their impact on breathlessness. The scale has 4 subgroups; self-care (4 question), about home (six question), physical activity (2 question) and leisure time (3 question). The minimum score is 0 and maximum score is 75. Higher scores indicate worse conditions.
Bioelectrical Impedance
Bioelectrical impedance analysis will be performed using the Tanita Bc 730 Innerscan Body Composition Analyzer to measure muscle mass.
Sarcopenia Screening Test (SARC-F)
A questionnaire is used to assess sarcopenia-related symptoms.The questionnaire screens patients for self-reported signs suggestive of sarcopenia, which include deficiencies in strength, walking, rising from a chair, climbing stairs, and experiencing falls. Each of the self-reported parameters receives a minimum and maximum score of 0 and 2, respectively, with the greatest maximum SARC-F score being 10. Higher scores mean worse outcome
International Physical Activity Questionnaire (Short Form)
This questionnaire is used to determine the level of physical activity.Inactive No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. Minimally Active Any one of the following 3 criteria 3 or more days of vigorous activity of at least 20 minutes per day OR 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week. active Any one of the following 2 criteria Vigorous-intensity activity on at least 3 days and accumulating at least 1500 METminutes/week OR 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Berg Balance Scale
This scale is used to evaluate balance and determine the risk of falls, primarily in elderly adults. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Bioelectrical Impedance-1
Bioelectrical impedance analysis will be performed using the Tanita Bc 730 Innerscan Body Composition Analyzer to measure body fat.

Full Information

First Posted
October 6, 2023
Last Updated
October 13, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT06087692
Brief Title
Efficacy of Video-Based Interactive Game Therapy in Interstitial Lung Patients
Official Title
Efficacy of Video-Based Interactive Game Therapy in Interstitial Lung Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence.
Detailed Description
Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. Many forms of ILD are progressive over time, associated with severely disabling symptoms and poor quality of life, yet medical treatment options are often limited. There are no specific pulmonary rehabilitation guidelines for this patient population, and standard programs are adapted on a patient basis. However, it is seen that the participation and attendance of patients in pulmonary rehabilitation programs is low, and the benefits obtained from the programs are gradually lost after completing the intensive rehabilitation process and breaking contact with the rehabilitation team. For these reasons, the guidelines emphasize the need to implement new strategies that can overcome limitations, and it is stated that there is a need for research and development of new program models that will make evidence-based pulmonary rehabilitation more accessible for patients. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence. Hypotheses: H0: Video-based game therapy applied in addition to aerobic exercise in patients with ILD has has no effect on exercise capacity, quality of life and physical fitness level. H1: Video-based game therapy applied in addition to aerobic exercise in patients with ILD increases exercise capacity, quality of life and physical fitness level. Patients in the Nintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 20 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 40 minutes. Patients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 20-30 minutes, accompanied by a physiotherapist. After eight weeks, all assessments will be repeated. As a result of this study, the contribution of video-based interactive game therapy to exercise capacity, peripheral muscle strength, physical activity level, symptoms, activity and participation levels in patients with ILD will be determined and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Video-based game therapy, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomized-Controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Other
Arm Description
Patients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 20-30 minutes, accompanied by a physiotherapist.
Arm Title
Nintendo +aerobic exercise
Arm Type
Other
Arm Description
Nintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 20 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 40 minutes.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Physical activity recommendation and respiratory exercises
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
-based game therapy applied in addition to aerobic exercise
Primary Outcome Measure Information:
Title
6 minute walk test
Description
6 minute walk test:Used to determine submaximal functional exercise capacity. Patients are asked to walk as far as possible in a 30-meter straight corridor at their own walking pace for six minutes. The patient rests in a sitting position for 10 minutes in the corridor before starting the test. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The distance walked in six minutes is recorded.
Time Frame
through study completion, an average of 1 year
Title
Incremental Shuttle Walk Test
Description
Incremental Shuttle Walk Test (ISWT): Used to determine functional exercise capacity. Patients walk around a cassette with signals previously recorded at a rate of 0.17 m/s, which increases every minute, starting at a pace of 10 meters per minute. The test consists of a maximum of 12 stages. The test is terminated if the patient cannot complete it within the allowed time (if the patient is more than 0.5 meters away from the signal cone when the signal sounds) or if the patient reaches 85% of the predicted maximum heart rate calculated according to the formula [210 - (0.65 x age)]. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking distance is recorded.
Time Frame
through study completion, an average of 1 year
Title
Endurance Shuttle Walk Test
Description
Endurance Shuttle Walk Test (ESWT): Endurance capacity is determined using ESWT. The walking speed (workload) to be used in ESWT will be calculated as 85% of the maximum sustainable speed obtained from ISWT. Patients are asked to warm up by walking at a slower pace for two minutes and then to walk at a steady pace. The test is terminated if the patient feels too breathless to continue walking, becomes fatigued, or completes the 20-minute test duration. Oxygen saturation, heart rate, blood pressure, dyspnea, and leg fatigue scores are recorded before and after the test. The walking time is recorded in seconds.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Respiratory Muscle Strength
Description
Measurement of respiratory muscle strength will be performed using an electronic mouth pressure measurement device, the "MicroRPM" brand (Micro Medical; UK), in accordance with ATS and ERS criteria.
Time Frame
through study completion, an average of 1 year
Title
Muscle strength
Description
Quadriceps Function Assessment;Quadriceps muscle strength will be evaluated using a hand-held dynamometer (J-Tech CommanderTM Muscle Tester, USA) by performing maximal voluntary isometric contractions (break test).
Time Frame
through study completion, an average of 1 year
Title
Dyspnea
Description
The Modified Medical Research Council Scale is used to assess the level of dyspnea experienced in daily life.The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 4 (normal) to Grade 0 (no visible contraction).
Time Frame
through study completion, an average of 1 year
Title
Fatigue
Description
A 9-item Fatigue Severity Scale is created by selecting fatigue-related characteristics. Each question is rated on a scale of 1-7, with 1 indicating no effect and 7 indicating a high impact. The total score is calculated as the sum or average of all responses.
Time Frame
through study completion, an average of 1 year
Title
Patient Satisfaction
Description
The Global Change Scale is used to assess the perceived effect of the treatment on the patient's current health condition.In most cases, a 5 or 6 item Likert scale is used ranging from 0 = Fail; 1 = Borderline; 2 = Pass; 3 = Good to 4 = Excellent.
Time Frame
through study completion, an average of 1 year
Title
The Saint George Respiratory Questionnaire
Description
The Saint George Respiratory Questionnaire (SGRQ) is used to assess health-related quality of life. It consists of 50 questions and three subscales: symptoms, activity, and impact.Scores range from 0 to 100, with higher scores indicating more limitations.
Time Frame
through study completion, an average of 1 year
Title
Daily Life Activities:
Description
The London Chest Activity of Daily Living Scale (LCADL) is used to assess daily life activities and their impact on breathlessness. The scale has 4 subgroups; self-care (4 question), about home (six question), physical activity (2 question) and leisure time (3 question). The minimum score is 0 and maximum score is 75. Higher scores indicate worse conditions.
Time Frame
through study completion, an average of 1 year
Title
Bioelectrical Impedance
Description
Bioelectrical impedance analysis will be performed using the Tanita Bc 730 Innerscan Body Composition Analyzer to measure muscle mass.
Time Frame
through study completion, an average of 1 year
Title
Sarcopenia Screening Test (SARC-F)
Description
A questionnaire is used to assess sarcopenia-related symptoms.The questionnaire screens patients for self-reported signs suggestive of sarcopenia, which include deficiencies in strength, walking, rising from a chair, climbing stairs, and experiencing falls. Each of the self-reported parameters receives a minimum and maximum score of 0 and 2, respectively, with the greatest maximum SARC-F score being 10. Higher scores mean worse outcome
Time Frame
through study completion, an average of 1 year
Title
International Physical Activity Questionnaire (Short Form)
Description
This questionnaire is used to determine the level of physical activity.Inactive No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. Minimally Active Any one of the following 3 criteria 3 or more days of vigorous activity of at least 20 minutes per day OR 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week. active Any one of the following 2 criteria Vigorous-intensity activity on at least 3 days and accumulating at least 1500 METminutes/week OR 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Time Frame
through study completion, an average of 1 year
Title
Berg Balance Scale
Description
This scale is used to evaluate balance and determine the risk of falls, primarily in elderly adults. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Time Frame
through study completion, an average of 1 year
Title
Bioelectrical Impedance-1
Description
Bioelectrical impedance analysis will be performed using the Tanita Bc 730 Innerscan Body Composition Analyzer to measure body fat.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by a chest diseases specialist, aged between 40-65 years, and have been under follow-up for at least 6 months according to the current ATS/ERS guidelines. Clinically stable, with no exacerbations or infections. Able to walk, with no visual or auditory impairments. Patients with cognitive abilities sufficient to understand commands. Exclusion Criteria: Orthopedic and neurological problems that could hinder exercise training. Changes in medical treatment during the study. Unstable cardiac diseases. Insufficient cooperation. Diagnosed visual, auditory, vestibular, or neurological problems that could affect balance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melike Sarıtaş Arslan, PhdC
Phone
5542320882
Email
mlksrts@hotmail.com
Facility Information:
Facility Name
İstanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melike Sarıtaş Arslan, PHDc
Phone
5542320882
Email
mlksrts@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18245143
Citation
Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Thorax. 2008 Jun;63(6):549-54. doi: 10.1136/thx.2007.088070. Epub 2008 Feb 1.
Results Reference
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Efficacy of Video-Based Interactive Game Therapy in Interstitial Lung Patients

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