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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomized-Controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aerobic Exercise<br>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. | Other: Exercise<br>* -based game therapy applied in addition to aerobic exercise<br>|
| Other: Nintendo +aerobic exercise<br>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. | Other: Exercise<br>* -based game therapy applied in addition to aerobic exercise<br>|
| No Intervention: Control<br>Physical activity recommendation and respiratory exercises | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 1 year | 
| 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). | through study completion, an average of 1 year | 
| 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). | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 
| Bioelectrical Impedance | Bioelectrical impedance analysis will be performed using the Tanita Bc 730 Innerscan Body Composition Analyzer to measure muscle mass. | through study completion, an average of 1 year | 
| 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 | through study completion, an average of 1 year | 
| 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 | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 
| Bioelectrical Impedance-1 | Bioelectrical impedance analysis will be performed using the Tanita Bc 730 Innerscan Body Composition Analyzer to measure body fat. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video-based game therapy, Aerobic Exercise