Clinical trial NCT06087692: 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
Overall status: RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: Video-based game therapy
Aerobic Exercise
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized-Controlled
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6 minute walk test
timeFrame: through study completion, an average of 1 year
measure: Incremental Shuttle Walk Test
timeFrame: through study completion, an average of 1 year
measure: Endurance Shuttle Walk Test
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Respiratory Muscle Strength
timeFrame: through study completion, an average of 1 year
measure: Muscle strength
timeFrame: through study completion, an average of 1 year
measure: Dyspnea
timeFrame: through study completion, an average of 1 year
measure: Fatigue
timeFrame: through study completion, an average of 1 year
measure: The Saint George Respiratory Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Daily Life Activities:
timeFrame: through study completion, an average of 1 year
measure: International Physical Activity Questionnaire (Short Form)
timeFrame: through study completion, an average of 1 year
measure: Leicester Cough Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Global rating of change (GRC)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Faculty of Medicine
Study officials:
affiliation: Marmara University
name: Aysel Yıldız Özer, Prof.
role: STUDY_DIRECTOR
References:
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.