Main
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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:
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ANZCTR |
Last refreshed on:
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28 October 2019 |
Main ID: |
ACTRN12617000275369 |
Date of registration:
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22/02/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of the effects of rehabilitation with the use of virtual reality in patients with chronic obstructive pulmonary disease
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Scientific title:
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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:
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03/08/2015 |
Target sample size:
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120 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12617000275369.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Poland
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Contacts
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Name:
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Mr Sebastian Rutkowski
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Address:
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Opole University of Technology 76 Proszkowska Street 45-758 Opole
Poland |
Telephone:
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+48507027792 |
Email:
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s.rutkowski@po.opole.pl |
Affiliation:
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Name:
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A/Prof Jan Szczegielniak
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Address:
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Opole University of Technology 76 Proszkowska Street 45-758 Opole
Poland |
Telephone:
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+48774498000 |
Email:
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jan.szczegielniak@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Physical Medicine / Rehabilitation - Physiotherapy
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Respiratory - Chronic obstructive pulmonary disease
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chronic obstructive pulmonary disease; chronic obstructive pulmonary disease
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Intervention(s)
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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
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Primary Outcome(s)
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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]
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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]
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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]
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Secondary Outcome(s)
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quality of life assessed using St George's Respiratory Questionnaire[1. baseline - Initial assessment of the patient,]
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Source(s) of Monetary Support
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The Opole University of Technology
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Ethics review
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Status: Approved
Approval date:
Contact:
Bioethical commission Opole Medical Chamber in Opole
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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