Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567772
• Other study ID #: USebelasMaret
• Status: Completed
• Phase: N/A
• Start date: February 1, 2014
• Est. completion date: July 30, 2014

Study information

• Verified date: June 2018
• Source: Universitas Sebelas Maret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

1. Yoga with "deep breathing" and "half moon" : patients performed technique of breathing and held a particular pose or series of poses for 10 minutes.

2. "torso twist" : a strength training exercise in which patients perform a number of repetitions of the selected exercise.

3. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2014
• Est. primary completion date: March 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Wiifit Nintendo video game

Other:
• Pulmonary rehabilitation program

Locations

Country	Name	City	State
Indonesia	Pulmonary department of medical faculty Universitas Sebelas Maret	Surakarta	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation

Celli 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. — View Citation

Cote CG, Celli BR. Pulmonary rehabilitation and the BODE index in COPD. Eur Respir J. 2005 Oct;26(4):630-6. — View Citation

de 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. — View Citation

Holland 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. Review. — View Citation

Jones 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. — View Citation

Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax. 2001 Nov;56(11):880-7. Review. — View Citation

Mahler 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. — View Citation

Maltais F, LeBlanc P, Jobin J, Bérubé 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. — View Citation

Turnip 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks

External Links

•   2018 Global strategy for prevention, diagnosis and management of COPD. http://goldcopd.org/gold-reports/. Accessed April 26, 2018.