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Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03567772
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Yusup subagio sutanto, Universitas Sebelas Maret

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Wiifit Nintendo video game Other: Pulmonary rehabilitation program Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : March 30, 2014
Actual Study Completion Date : July 30, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wiifit Nintendo video game
Pulmonary rehabilitation program using video games exercise from Nintendo
Device: Wiifit Nintendo video game
Other: Pulmonary rehabilitation program
Active Comparator: Pulmonary rehabilitation program
Pulmonary rehabilitation program with ergometer cycle
Other: Pulmonary rehabilitation program



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Health related quality of life: St George's Respiratory Questionnaire (SGRQ) [ Time Frame: 6 weeks ]
    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

  2. Dyspnea [ Time Frame: 6 weeks ]
    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



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567772


Locations
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Indonesia
Pulmonary department of medical faculty Universitas Sebelas Maret
Surakarta, Central Java, Indonesia, 57126
Sponsors and Collaborators
Universitas Sebelas Maret
Investigators
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Study Director: Ana Rima, Dr Pulmonary Department of Medical faculty Universitas Sebelas Maret, Surakarta Indonesia

Additional Information:
Publications:
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

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Responsible Party: Yusup subagio sutanto, Head of Pulmonary Department, medical faculty of Universitas Sebelas Maret, Universitas Sebelas Maret
ClinicalTrials.gov Identifier: NCT03567772     History of Changes
Other Study ID Numbers: USebelasMaret
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yusup subagio sutanto, Universitas Sebelas Maret:
Video-game assisted rehabilitation
COPD
Exercise tolerance

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases