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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06087692
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Istanbul University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Turkey
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease

Additional Details

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.

Arms & Interventions

Arms

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 20-30 minutes, accompanied by a physiotherapist.

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 20 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 40 minutes.

No Intervention: Control

Physical activity recommendation and respiratory exercises

Interventions

Other: - Exercise

-based game therapy applied in addition to aerobic exercise

Contact a Trial Team

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