Clinical trial NCT03567772: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Video-game assisted rehabilitation
COPD
Exercise tolerance
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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).

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.

Primary outcomes:
measure: Exercise tolerance
timeFrame: 6 weeks
Secondary outcomes:
measure: Health related quality of life: St George's Respiratory Questionnaire (SGRQ)
timeFrame: 6 weeks
measure: Dyspnea
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: Pulmonary department of medical faculty Universitas Sebelas Maret
state: Central Java
Study officials:
affiliation: Pulmonary Department of Medical faculty Universitas Sebelas Maret, Surakarta Indonesia
name: Ana Rima, Dr
role: STUDY_DIRECTOR
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