Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Wiifit Nintendo video game
Pulmonary rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Video-game assisted rehabilitation, COPD, Exercise tolerance
Eligibility Criteria
Inclusion Criteria:
- COPD based on GOLD guidelines
- COPD stable (no exacerbation in the four weeks prior to study)
Exclusion Criteria:
- refusal to participate
- participation in a PRP during the previous 6 months
- severe concomitant comorbidities such as ischaemic cardiac disease, chronic heart failure, orthopaedic and/or neuromuscular diseases interfering with their ability to walk.
Dropout criteria:
- acute exacerbation
- inability or unwillingness to follow the research program.
Sites / Locations
- Pulmonary department of medical faculty Universitas Sebelas Maret
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wiifit Nintendo video game
Pulmonary rehabilitation program
Arm Description
Pulmonary rehabilitation program using video games exercise from Nintendo
Pulmonary rehabilitation program with ergometer cycle
Outcomes
Primary Outcome Measures
Exercise tolerance
Before and after the pulmonary rehabilitation program the exercise tolerance is measured by Six minute walking distance test (6MWT). Participants have to walk as far as possible for 6 minutes. Participants will walk back and forth in the hallway. Six minutes is a long time to walk, participants are permitted to slow down, to stop and to rest as necessary. The scale will be in meter (m). Higher values represent a better outcome
Secondary Outcome Measures
Health related quality of life: St George's Respiratory Questionnaire (SGRQ)
Before and after the pulmonary rehabilitation program, health related quality of life is measured by St George's Respiratory Questionnaire (SGRQ). Three component scores are calculated: symptoms; activity; impacts. One total score is also calculated. Each questionnaire response has a unique empirically derrived weight. The lowest possible weight is zero and the highest is 100. Higher values represent a worse outcome
Dyspnea
Before and after the pulmonary rehabilitation program the dyspnoea was assessed by means of the Baseline (BDI) and Transitional (TDI) dyspnoea index. Three component scores are calculated: functional impairment; magnitude of task; magnitude of effort. The lowest possible score is -3 and the highest score is +3. Higher values represent a better outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03567772
Brief Title
Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
March 30, 2014 (Actual)
Study Completion Date
July 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pulmonary rehabilitation programs (PRP) are a key factor of comprehensive management of patients with chronic obstructive pulmonary disease (COPD). Interactive game-based systems have been proposed to improve effects and/or compliance to PRP. The aim of this study is to evaluate the effectiveness of wiifit nintendo as a PRP tool in COPD patients with a randomized controlled trial methods. The patients were divided into experimental (EG) and control (CG) group. The EG performed wiifit program (yoga, strength training, aerobic exercise) twice a week for 6 weeks, the CG performed cycle ergometer twice a week for 6 weeks. The investigators evaluated pre and post treatment: Six-minute walking test, Transitional Dyspnea Index, and Saint George Respiratory Questionnaire.The hypothesis are the EG able to show improvement in exercise tolerance, dyspnea, and quality of life.
Detailed Description
In this randomised clinical trial (RCT) subjects were assigned to two groups: the Experimental Group (EG) received a hospital based outpatient PRP and Wii Fit videogame program; the Control Group (CG) received only a standard hospital based outpatient PRP. Researchers evaluating results and patients were not blind to treatment. Patients maintained their usual drug medication according to accepted Guidelines.
Patients of both groups received for six weeks three weekly 30-minute sessions of supervised standard cycle exercise training at outpatient clinics under the supervision of doctors and nurses. Oxygen pulse oximetry (SpO2), arterial blood pressure, heart rate (HR) and dyspnoea (by a 10-point modified Borg scale) were monitored.
In addition to each session of exercise training, patients of EG performed also 30 minute session of supervised video-game assisted program in a dedicated room equipped with Wii Nintendo, balance board, and flatscreen television. Participants played 3 different games per session:
Yoga with "deep breathing" and "half moon" : patients performed technique of breathing and held a particular pose or series of poses for 10 minutes.
"torso twist" : a strength training exercise in which patients perform a number of repetitions of the selected exercise.
aerobic exercises "free run": the patient runs in place while keeping the connected Wii Remote in his or her pocket, which acts as a pseudo-pedometer.
The primary outcome measure was the 6MWT. Results are shown as mean (Standard Deviation: SD) for continuous and as numbers (percentage frequency) for discrete variables. To determine the sample size, an earlier study showed a post-program 70.4 (18.3) meter mean increase in 6MWT.
The study hypothesis was therefore to observe a 30 m post-PRP change in both groups. To obtain a 90% study power and an alpha error less than 5%, a minimum sample size of 12 patients completing the study was required in each group.
To obtain this result investigators estimated an allocation sample size of 40 patients, considering a 20% drop out rate.
Unpaired t test, Kruskall-Wallis H test, and X2 analyses for dichotomous variables were used when appropriate for comparison between groups to test any baseline difference.
The two-way repeated measures ANOVA was carried out to compare the improvements of both groups.
Chi-square test was used to compare continuous and categorical variables. A p value less than 0.05 was considered as statistically significant. Analyses were performed using a specific package (SPSS for Windows latest version, Chicago, Illinois, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Video-game assisted rehabilitation, COPD, Exercise tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wiifit Nintendo video game
Arm Type
Experimental
Arm Description
Pulmonary rehabilitation program using video games exercise from Nintendo
Arm Title
Pulmonary rehabilitation program
Arm Type
Active Comparator
Arm Description
Pulmonary rehabilitation program with ergometer cycle
Intervention Type
Device
Intervention Name(s)
Wiifit Nintendo video game
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation program
Primary Outcome Measure Information:
Title
Exercise tolerance
Description
Before and after the pulmonary rehabilitation program the exercise tolerance is measured by Six minute walking distance test (6MWT). Participants have to walk as far as possible for 6 minutes. Participants will walk back and forth in the hallway. Six minutes is a long time to walk, participants are permitted to slow down, to stop and to rest as necessary. The scale will be in meter (m). Higher values represent a better outcome
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Health related quality of life: St George's Respiratory Questionnaire (SGRQ)
Description
Before and after the pulmonary rehabilitation program, health related quality of life is measured by St George's Respiratory Questionnaire (SGRQ). Three component scores are calculated: symptoms; activity; impacts. One total score is also calculated. Each questionnaire response has a unique empirically derrived weight. The lowest possible weight is zero and the highest is 100. Higher values represent a worse outcome
Time Frame
6 weeks
Title
Dyspnea
Description
Before and after the pulmonary rehabilitation program the dyspnoea was assessed by means of the Baseline (BDI) and Transitional (TDI) dyspnoea index. Three component scores are calculated: functional impairment; magnitude of task; magnitude of effort. The lowest possible score is -3 and the highest score is +3. Higher values represent a better outcome
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD based on GOLD guidelines
COPD stable (no exacerbation in the four weeks prior to study)
Exclusion Criteria:
refusal to participate
participation in a PRP during the previous 6 months
severe concomitant comorbidities such as ischaemic cardiac disease, chronic heart failure, orthopaedic and/or neuromuscular diseases interfering with their ability to walk.
Dropout criteria:
acute exacerbation
inability or unwillingness to follow the research program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Rima, Dr
Organizational Affiliation
Pulmonary Department of Medical faculty Universitas Sebelas Maret, Surakarta Indonesia
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary department of medical faculty Universitas Sebelas Maret
City
Surakarta
State/Province
Central Java
ZIP/Postal Code
57126
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Links:
URL
http://goldcopd.org/gold-reports/
Description
2018 Global strategy for prevention, diagnosis and management of COPD. http://goldcopd.org/gold-reports/. Accessed April 26, 2018.
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Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
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