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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 28 October 2019
Main ID:  ACTRN12617000275369
Date of registration: 22/02/2017
Prospective Registration: No
Primary sponsor: The Opole University of Technology
Public title: Evaluation of the effects of rehabilitation with the use of virtual reality in patients with chronic obstructive pulmonary disease
Scientific title: Effect of hospital based physiotherapy for chronic obstructive pulmonary disease (COPD) patients with the use of virtual reality on physical fitness, lung function and dyspnea
Date of first enrolment: 03/08/2015
Target sample size: 120
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12617000275369.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Poland
Contacts
Name: Mr Sebastian Rutkowski   
Address:  Opole University of Technology 76 Proszkowska Street 45-758 Opole Poland
Telephone: +48507027792
Email: s.rutkowski@po.opole.pl
Affiliation: 
Name: A/Prof Jan Szczegielniak   
Address:  Opole University of Technology 76 Proszkowska Street 45-758 Opole Poland
Telephone: +48774498000
Email: jan.szczegielniak@gmail.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Diagnosed COPD in categories B, C GOLD;

Exclusion criteria: * No patient consent to participate in research
* Age below 50 and above 70 years of age
* Pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms
* Condition after a heart attack
* Diabetes
* State after thoracic and cardiac surgery
* Heart failure (stage III, IV ° NYHA)
* Advanced hypertension
* Diseases and injuries that can impair the function of the musculoskeletal system of transportation
* Cognitive disorders, to prevent contact with the patient.


Age minimum: 50 Years
Age maximum: 70 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Physical Medicine / Rehabilitation - Physiotherapy
Respiratory - Chronic obstructive pulmonary disease
chronic obstructive pulmonary disease;
chronic obstructive pulmonary disease
Intervention(s)
The objective of the study is to evaluate the usefulness of exercise training using the Xbox Kinect system during hospital rehabilitation of patients with COPD. In this project, it is proposed to: Implement and evaluate Xbox Kinect training session as a tool in pulmonary rehabilitation and compare the effects of a standard rehabilitation program with the results of the program enriched with sessions using X-box Kinect.
For the study will be recruited 120 patients with COPD (II and III GOLD) Hospital Interior Ministry in Glucholazy. The subjects will be randomly assigned to 3 groups.
Group I is the control group. Patients will participate in improving the existing models of pulmonary rehabilitation by Szczegielniak. Pulmonary rehabilitation program will last for three weeks
Group II will participate in pulmonary rehabilitation by Szczegielniak models, in addition to participating in 20 minutes training using video games available for the Xbox Kinect system.
Group III will participate in pulmonary rehabilitation by Szczegielniak models, but the training on a cycle ergometer or treadmill will be replaced by the Xbox Kinect system.
Patients, depending on their exercise tolerance will be enrolled to appropriate model of rehabilitation and then undergo different types of physiotherapy treatment, mainly based on physical exercise on a bicycle ergometer.
Patients with COPD will be enrolled to model B or C of PR by Szczegielniak based on the results of submaximal exercise and spirometry tests.
Model B
* specific respiratory exercises for 30 minutes - relaxation exercises for breathing muscles, strengthening exercises the diaphragm with resistance, exercises to increase costal or chest breathing, prolonged exhalation exercise, chest percussion, once a day for 30 min, 5-time a week;
* training on a cycle ergometer or treadmill, twice a day for 20-30 min.- until the Heart Rate reaches 60% of the HRmax (220-age),
* 30 minutes of fitness and respir
Primary Outcome(s)
dyspnea assessed using Borg Scale[1. baseline - Initial assessment of the patient,
2. 3 weeks - Final assessment of patient after 3 weeks of PR– including physical fitness assessment]
physical fitness (endurance, fatigue) assessed using Functional Fitness Test[1. baseline - Initial assessment of the patient,
2. 3 weeks - Final assessment of patient after 3 weeks of PR– including physical fitness assessment]
Lung function (composite of FEV1, FVC, FEV1%FVC) assessed using spirometry[1. baseline - Initial assessment of the patient,
2. 3 weeks - Final assessment of patient after 3 weeks of PR– including physical fitness assessment]
Secondary Outcome(s)
quality of life assessed using St George's Respiratory Questionnaire[1. baseline - Initial assessment of the patient,]
Secondary ID(s)
none
Source(s) of Monetary Support
The Opole University of Technology
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Bioethical commission Opole Medical Chamber in Opole
Results
Results available:
Date Posted:
Date Completed:
URL:
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