Chronic Obstructive Pulmonary DiseaseNCT03567772
Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
A study testing Wiifit Nintendo video game and Pulmonary rehabilitation program in people with Chronic Obstructive Pulmonary Disease, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Wiifit Nintendo video game and Pulmonary rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2014to 30 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD based on GOLD guidelines
- COPD stable (no exacerbation in the four weeks prior to study)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Pulmonary department of medical faculty Universitas Sebelas Maret
Surakarta, Central Java, 57126
About this study
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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Wiifit Nintendo video game, Pulmonary rehabilitation program
- Keywords
- Video-game assisted rehabilitation, COPD, Exercise tolerance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wiifit Nintendo video gameDevice
Pulmonary rehabilitation programOther
| Study group | Role | What they receive |
|---|---|---|
| Wiifit Nintendo video game | Experimental | Pulmonary rehabilitation program using video games exercise from Nintendo Receives: Device: Wiifit Nintendo video game; Other: Pulmonary rehabilitation program |
| Pulmonary rehabilitation program | Active comparator | Pulmonary rehabilitation program with ergometer cycle Receives: Other: Pulmonary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (2)
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
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Feb 2014
- Primary completion30 Mar 2014
- Study completion30 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusup subagio sutanto, Universitas Sebelas Maret
- Investigators
- Ana Rima, Dr, Study director, Pulmonary Department of Medical faculty Universitas Sebelas Maret, Surakarta Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567772
- Sponsor's protocol ID
- USebelasMaret
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Maltais F, LeBlanc P, Jobin J, Berube C, Bruneau J, Carrier L, Breton MJ, Falardeau G, Belleau R. Intensity of training and physiologic adaptation in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Feb;155(2):555-61. doi: 10.1164/ajrccm.155.2.9032194.
PubMed 9032194Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. doi: 10.1378/chest.85.6.751.
PubMed 6723384Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
PubMed 1595997Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax. 2001 Nov;56(11):880-7. doi: 10.1136/thorax.56.11.880.
PubMed 11641515Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355de Torres JP, Pinto-Plata V, Ingenito E, Bagley P, Gray A, Berger R, Celli B. Power of outcome measurements to detect clinically significant changes in pulmonary rehabilitation of patients with COPD. Chest. 2002 Apr;121(4):1092-8. doi: 10.1378/chest.121.4.1092.
PubMed 11948037Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
PubMed 14999112Cote CG, Celli BR. Pulmonary rehabilitation and the BODE index in COPD. Eur Respir J. 2005 Oct;26(4):630-6. doi: 10.1183/09031936.05.00045505.
PubMed 16204593Turnip H, Ratnawati A, Tulaar A, Yunus F, Kekalih A. Comparison of the effects of treadmill and ergocycle exercise on the functional capacity and quality of life of patients with chronic obstructive pulmonary disease. Med J Indonesia. 2014; 23: 42-47
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03567772
- Acronym / sponsor ID
- USebelasMaret
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Video-game assisted rehabilitation, COPD, Exercise tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 30 Mar 2014 (actual)
- Study completion
- 30 Jul 2014 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wiifit Nintendo video game | Experimental | Device: Wiifit Nintendo video game, Other: Pulmonary rehabilitation programPulmonary rehabilitation program using video games exercise from Nintendo |
| Pulmonary rehabilitation program | Active comparator | Other: Pulmonary rehabilitation programPulmonary rehabilitation program with ergometer cycle |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD based on GOLD guidelines
- COPD stable (no exacerbation in the four weeks prior to study)
Key exclusion criteria (6 listed)
- 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.
- acute exacerbation
- inability or unwillingness to follow the research program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wiifit Nintendo video game | Device | Wiifit Nintendo video game |
| Pulmonary rehabilitation program | Other | Pulmonary rehabilitation program, Wiifit Nintendo video game |
Primary outcome
Exercise tolerance
Time frame: 6 weeks
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
2 secondary outcomes
Health related quality of life: St George's Respiratory Questionnaire (SGRQ)
Time frame: 6 weeks
Dyspnea
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 9032194Maltais F, LeBlanc P, Jobin J, Berube C, Bruneau J, Carrier L, Breton MJ, Falardeau G, Belleau R. Intensity of training and physiologic adaptation in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Feb;155(2):555-61. doi: 10.1164/ajrccm.155.2.9032194.
- Background: PubMed 6723384Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. doi: 10.1378/chest.85.6.751.
- Background: PubMed 1595997Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
- Background: PubMed 11641515Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax. 2001 Nov;56(11):880-7. doi: 10.1136/thorax.56.11.880.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 11948037de Torres JP, Pinto-Plata V, Ingenito E, Bagley P, Gray A, Berger R, Celli B. Power of outcome measurements to detect clinically significant changes in pulmonary rehabilitation of patients with COPD. Chest. 2002 Apr;121(4):1092-8. doi: 10.1378/chest.121.4.1092.
- Background: PubMed 14999112Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
- Background: PubMed 16204593Cote CG, Celli BR. Pulmonary rehabilitation and the BODE index in COPD. Eur Respir J. 2005 Oct;26(4):630-6. doi: 10.1183/09031936.05.00045505.
- BackgroundTurnip H, Ratnawati A, Tulaar A, Yunus F, Kekalih A. Comparison of the effects of treadmill and ergocycle exercise on the functional capacity and quality of life of patients with chronic obstructive pulmonary disease. Med J Indonesia. 2014; 23: 42-47
- 2018 Global strategy for prevention, diagnosis and management of COPD. http://goldcopd.org/gold-reports/. Accessed April 26, 2018.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rima, Dr study director
Pulmonary Department of Medical faculty Universitas Sebelas Maret, Surakarta Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wiifit Nintendo video game and Pulmonary rehabilitation program in people with Chronic Obstructive Pulmonary Disease, run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03567772, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.