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

NCT06087692 | Recruiting

• 1 other identifier: PHD Thesis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Keywords

Video-based game therapy; Aerobic Exercise

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Respiratory Muscle Strength

  through study completion, an average of 1 year

• Muscle strength

  through study completion, an average of 1 year

• Dyspnea

  through study completion, an average of 1 year

• Fatigue

  through study completion, an average of 1 year

• The Saint George Respiratory Questionnaire

  through study completion, an average of 1 year

Study Arms (3)

Aerobic Exercise

OTHER

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

Nintendo +aerobic exercise

OTHER

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

Control

OTHER

Physical activity recommendation and respiratory exercises

Other: Exercise

Interventions

Exercise OTHER

-based game therapy applied in addition to aerobic exercise

Aerobic Exercise; Control; Nintendo +aerobic exercise

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

İstanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 18245143 BACKGROUND

• Arslan MS, Ozer AY, Bingol Z, Okumus G. Effectiveness of Active Video Games as a Training Tool in Patients With Interstitial Lung Disease: A Randomised Controlled Trial. Respirology. 2025 Dec 4. doi: 10.1002/resp.70166. Online ahead of print.

  PMID: 41344887 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aysel Yıldız Özer, Prof.

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Melike Sarıtaş Arslan, PhdC

CONTACT

5542320882; mlksrts@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized-Controlled

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 18, 2023
• Study Start: January 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)