Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
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.
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).
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