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

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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: Exercise

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 30 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 30 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melike Sarıtaş Arslan, PHDc; Phone Number: 5542320882; Email: mlksrts@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Recruiting
    • Istanbul Faculty of Medicine
    • Contact: Melike Sarıtaş Arslan, PHDc; Phone Number: 5542320882; Email: mlksrts@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosed with ILD (Interstitial lung 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aerobic Exercise; 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 30 minutes, accompanied by a physiotherapist.	Other: Exercise; -based game therapy applied in addition to aerobic exercise
Other: Nintendo +aerobic exercise; 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 30 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 30 minutes.	Other: Exercise; -based game therapy applied in addition to aerobic exercise
Other: Control; Physical activity recommendation and respiratory exercises	Other: Exercise; -based game therapy applied in addition to aerobic exercise

What is the study measuring?

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
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
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
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 criteria3 or more days of vigorous activity of at least 20 minutes per day OR5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR5 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 criteriaVigorous-intensity activity on at least 3 days and accumulating at least 1500 METminutes/week OR7 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
Global rating of change (GRC)	Global rating of change (GRC): Patient satisfaction was assessed by GRC at the end of the study. Global rating of change (GRC) scales are designed to quantify a patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition (21). The responses for the GRC were "much better"; "slightly better"; "stayed the same"; "slightly worse" or "much worse".	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Aysel Yıldız Özer, Prof., Marmara University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Aerobic Exercise; Video-based game therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: PhD Thesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No