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

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087692
• Other study ID #: PHD Thesis
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2024
• Source: Istanbul University
• Contact: Melike Saritas Arslan, PhdC
• Phone: 5542320882
• Email: mlksrts[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Exercise
-based game therapy applied in addition to aerobic exercise

Locations

Country	Name	City	State
Turkey	Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Leicester Cough Questionnaire	Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic coug. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score. It generally takes about 5 minutes to be completed and it is designed for adults.The total severity score ranges from 3 to 21, with a lower score indicating greater impairment of health status due to cough.	through study completion, an average of 1 year