Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000275369
Ethics application status
Approved
Date submitted
21/12/2016
Date registered
22/02/2017
Date last updated
21/10/2019
Date data sharing statement initially provided
21/10/2019
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 290800 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 301449 0
Condition category
Condition code
Respiratory 301165 301165 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 301166 301166 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 respiratory exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. Performed in a standing position, kneeling, sitting, lying on side, abdomen and back.
* walking / Nordic Walking (depending on weather and health condition of the patient) for 45 min.;
* relaxation training by Shultz and Jacobson. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation. Each session can be practiced in a position chosen amongst a set of recommended postures (for example, lying down, sitting meditation, sitting like a rag doll). The technique can be used to alleviate many stress-induced psychosomatic disorders.
Model C
* 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, once a day for 20-30 min.- until the Heart Rate reaches 60% of the HRmax (220-age),
* 30 minutes of fitness and respiratory exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. Performed in a standing position, kneeling, sitting, lying on side, abdomen and back.
* walking / Nordic Walking (depending on weather and health condition of the patient) for 45 min.;
* relaxation training by Shultz and Jacobson. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation. Each session can be practiced in a position chosen amongst a set of recommended postures (for example, lying down, sitting meditation, sitting like a rag doll). The technique can be used to alleviate many stress-induced psychosomatic disorders.
Interventions are delivered in a groups.
Kinect training for II and III group:
In each game participant is to score the highest number of points awarded for quantitative and qualitative elements. The subjects will be played in each game at a basic level. During participation in the session, patients will be equipped with a device for measuring the heart rate, so as not to exceed the value of training established during the initial investigation. If the patient does not reach the heart rate of the training session will be extended. Expected time for one session of 15-30 minutes. Each training session will be consisted of 4 Kinect Adventures games:
* 20,000 Leaks - The player positions his/her limbs and head to plug cracks as sea creatures cause cracks and holes in the glass cube. Each game consists of three waves, which are timed and progress in difficulty as the game continues. As the game progresses the player may have to plug up to five cracks simultaneously requiring them to use their entire body. Each wave continues until time runs out or player is able to cover all cracks, points are awarded for each crack covered and for time remaining.
* Curvy Creek - The player stands in a raft and must try to collect as many adventure pins as possible throughout the course by weight-shifting, side-stepping or reaching to steer the raft. The player loses points by crashing into barriers
* Rally Ball - The player uses his/her limbs and head to hit balls at targets and blocks which are located in front of him/her. When specific targets are hit, the ball splits in to multiple balls which must be hit simultaneously, increasing the difficulty. This game consists of three rounds in which the player earns points for each target hit, balls collected, and remaining time.
* Reflex Ridge - The player stands on a moving platform that travels through a wooden track course. Player must squat/duck and lean side-to-side in order to avoid obstacles. Pins can be earned by avoiding obstacles, reaching to collect pins, and remaining time.
Game performance success will be evaluated as a number of points awarded to the participant. All interventions will take place in Hospital Interior Ministry in Glucholazy supervised by a physiotherapist
Intervention code [1] 296717 0
Rehabilitation
Intervention code [2] 297177 0
Treatment: Other
Comparator / control treatment
Control group will be assesses before and after 3-weeks pulmonary rehabilitation.
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 respiratory exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. Performed in a standing position, kneeling, sitting, lying on side, abdomen and back.
* walking / Nordic Walking (depending on weather and health condition of the patient) for 45 min.;
* relaxation training by Shultz and Jacobson. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation. Each session can be practiced in a position chosen amongst a set of recommended postures (for example, lying down, sitting meditation, sitting like a rag doll). The technique can be used to alleviate many stress-induced psychosomatic disorders.
Model C
* 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, once a day for 20-30 min.- until the Heart Rate reaches 60% of the HRmax (220-age),
* 30 minutes of fitness and respiratory exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. Performed in a standing position, kneeling, sitting, lying on side, abdomen and back.
* walking / Nordic Walking (depending on weather and health condition of the patient) for 45 min.;
* relaxation training by Shultz and Jacobson. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation. Each session can be practiced in a position chosen amongst a set of recommended postures (for example, lying down, sitting meditation, sitting like a rag doll). The technique can be used to alleviate many stress-induced psychosomatic disorders.
Control group
Active

Outcomes
Primary outcome [1] 300584 0
physical fitness (endurance, fatigue) assessed using Functional Fitness Test
Timepoint [1] 300584 0
1. baseline - Initial assessment of the patient,
2. 3 weeks - Final assessment of patient after 3 weeks of PR– including physical fitness assessment
Primary outcome [2] 300585 0
Lung function (composite of FEV1, FVC, FEV1%FVC) assessed using spirometry
Timepoint [2] 300585 0
1. baseline - Initial assessment of the patient,
2. 3 weeks - Final assessment of patient after 3 weeks of PR– including physical fitness assessment
Primary outcome [3] 300588 0
dyspnea assessed using Borg Scale
Timepoint [3] 300588 0
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 [1] 330352 0
quality of life assessed using St George's Respiratory Questionnaire
Timepoint [1] 330352 0
1. baseline - Initial assessment of the patient,

Eligibility
Key inclusion criteria
1. Diagnosed COPD in categories B, C GOLD;
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis will be carried out using Statistica 10 software. It was planned to determine the distribution of variables. In the absence of Fundamentals reject the hypothesis of a normal distribution is performed ANOVA with Tukey's test reproducible measurements do post-hoc, and with the rejection of the hypothesis of a normal distribution will be done Friedman ANOVA.The statistical significance level was accepted at p<0.05 for all tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/08/2015
Date of last participant enrolment
Anticipated
Actual
10/11/2016
Date of last data collection
Anticipated
Actual
2/12/2016
Sample size
Target
120
Accrual to date
Final
106
Recruitment outside Australia
Country [1] 8524 0
Poland
State/province [1] 8524 0
Opole

Funding & Sponsors
Funding source category [1] 295224 0
University
Name [1] 295224 0
The Opole University of Technology
Country [1] 295224 0
Poland
Primary sponsor type
University
Name
The Opole University of Technology
Address
76 Proszkowska Street
45-758 Opole
Country
Poland
Secondary sponsor category [1] 294052 0
None
Name [1] 294052 0
none
Address [1] 294052 0
none
Country [1] 294052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296568 0
Bioethical commission Opole Medical Chamber in Opole
Ethics committee address [1] 296568 0
Ethics committee country [1] 296568 0
Poland
Date submitted for ethics approval [1] 296568 0
03/12/2012
Approval date [1] 296568 0
07/02/2013
Ethics approval number [1] 296568 0
199/07.02.2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1341 1341 0 0
/AnzctrAttachments/372066-decyzjakomisjaPRELUDIUM.pdf (Ethics approval)
Attachments [2] 1342 1342 0 0
/AnzctrAttachments/372066-Bioethical commission Opole Medical Chamber in Opole.pdf (Ethics approval)

Contacts
Principal investigator
Name 71322 0
Mr Sebastian Rutkowski
Address 71322 0
Opole University of Technology 76 Proszkowska Street 45-758 Opole
Country 71322 0
Poland
Phone 71322 0
+48507027792
Fax 71322 0
Email 71322 0
[email protected]
Contact person for public queries
Name 71323 0
Sebastian Rutkowski
Address 71323 0
Opole University of Technology 76 Proszkowska Street 45-758 Opole
Country 71323 0
Poland
Phone 71323 0
+48507027792
Fax 71323 0
Email 71323 0
[email protected]
Contact person for scientific queries
Name 71324 0
Jan Szczegielniak
Address 71324 0
Opole University of Technology 76 Proszkowska Street 45-758 Opole
Country 71324 0
Poland
Phone 71324 0
+48774498000
Fax 71324 0
Email 71324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.