- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03567772
Videogame Assisted Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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:
- Yoga with "deep breathing" and "half moon" : patients performed technique of breathing and held a particular pose or series of poses for 10 minutes.
- "torso twist" : a strength training exercise in which patients perform a number of repetitions of the selected exercise.
- 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).
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Central Java
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Surakarta, Central Java, Indonezja, 57126
- Pulmonary department of medical faculty Universitas Sebelas Maret
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Wiifit Nintendo video game
Pulmonary rehabilitation program using video games exercise from Nintendo
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Aktywny komparator: Pulmonary rehabilitation program
Pulmonary rehabilitation program with ergometer cycle
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Exercise tolerance
Ramy czasowe: 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
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6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Health related quality of life: St George's Respiratory Questionnaire (SGRQ)
Ramy czasowe: 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
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6 weeks
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Dyspnea
Ramy czasowe: 6 weeks
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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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6 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Ana Rima, Dr, Pulmonary Department of Medical faculty Universitas Sebelas Maret, Surakarta Indonesia
Publikacje i pomocne linki
Publikacje ogólne
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
- de Torres JP, Pinto-Plata V, Ingenito E, Bagley P, Gray A, Berger R, Celli B. Power of outcome measurements to detect clinically significant changes in pulmonary rehabilitation of patients with COPD. Chest. 2002 Apr;121(4):1092-8. doi: 10.1378/chest.121.4.1092.
- Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. doi: 10.1378/chest.85.6.751.
- Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
- Maltais F, LeBlanc P, Jobin J, Berube C, Bruneau J, Carrier L, Breton MJ, Falardeau G, Belleau R. Intensity of training and physiologic adaptation in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Feb;155(2):555-61. doi: 10.1164/ajrccm.155.2.9032194.
- Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax. 2001 Nov;56(11):880-7. doi: 10.1136/thorax.56.11.880.
- Cote CG, Celli BR. Pulmonary rehabilitation and the BODE index in COPD. Eur Respir J. 2005 Oct;26(4):630-6. doi: 10.1183/09031936.05.00045505.
- 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
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
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