Pulmonary Rehabilitation in Asthmatic Patient
5. august 2019 oppdatert av: Fernanda de Cordoba Lanza
Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial
Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways.
Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations.
The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
The asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance.
Thus, the treatment of these individuals should be extended to pulmonary rehabilitation.
Randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents.
In a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial.
The control of the disease has not been evaluated by specific questionnaires in any study.
The assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training.
In addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results.
All these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.
Studietype
Intervensjonell
Registrering (Faktiske)
66
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Sao Paulo, Brasil, 01504001
- Fernanda C Lanza
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- between six and 18 years old
- asthma-diagnosed patients
- under medical treatment and disease control
Exclusion Criteria:
- fail to carry out the protocol evaluations
- interrupt the medical care and/or drug-based treatment
- acute lung infection or other chronic lung diseases
- other comorbidities (neuropathies, heart disease)
- missing in more than 20% the rehabilitation protocol
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention Group
The intervention group will have supervised rehabilitation program held twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks.
Each session will consist of three parts: aerobic training, strength training and respiratory physiotherapy.
The aerobic training will be held for 35 minutes (10 min of warm up, 20 min on target load and 5 min of slowdown) with initial intensity of 60% of the maximum load obtained in the maximal cardiopulmonary exercise testing or in incremental shuttle walk test (ISWT).
The intensity will be gradually increased up to 80%, so that fatigue or dyspnea values are kept between 4 and 6, according to the modified Borg scale.
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Aerobic training
Andre navn:
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Aktiv komparator: Control Group
The control group will be subjected to supervised respiratory physiotherapy and stretching exercises twice a week, each session with duration of 60 minutes, with minimum interval of 24 hours, for a period of 8 weeks.
The oral high-frequency oscillation device (Flutter®) will be used for 10 minutes, 5 minutes in each lateral decubitus, followed by the stretching of upper and lower limbs for 40 minutes.
All exercises will be active, performed in sitting and lying positions without increasing the heart rate.
The remaining 10 minutes will be used to discuss doubts about the disease and the use of the booklet.
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Chest physiotherapy: Flutter and muscle stretching
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)
Tidsramme: Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
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Modified shuttle test was conducted
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Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Muscle strength as measure by electromyography (EMG)
Tidsramme: Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).
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1 maximal repetition was performed
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Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).
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Muscle endurance as measure by electromyography (EMG)
Tidsramme: Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).
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Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).
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Quality of life measured by Pediatric questionnaire
Tidsramme: Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
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Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
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Inflammatory markers as measure by interleukines
Tidsramme: Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).
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Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Dirceu Solé, PhD, Unifesp, Federal University of Sao Paulo
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Silva EP, Soares BA, Reimberg MM, Ritti-Dias R, Nascimento KS, Anjos FS, Wandalsen GF, Sole D, Dal Corso S, Lanza FC. Heart rate recovery in asthmastic children and adolescents after clinical field test. BMC Pulm Med. 2021 Feb 19;21(1):61. doi: 10.1186/s12890-020-01355-9.
- Reimberg MM, Castro RA, Selman JP, Meneses AS, Politti F, Mallozi MC, Wandalsen GF, Sole D, De Angelis K, Dal Corso S, Lanza FC. Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial. Trials. 2015 Aug 13;16:346. doi: 10.1186/s13063-015-0876-x.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2015
Primær fullføring (Faktiske)
1. juli 2016
Studiet fullført (Faktiske)
1. august 2018
Datoer for studieregistrering
Først innsendt
10. februar 2015
Først innsendt som oppfylte QC-kriteriene
3. mars 2015
Først lagt ut (Anslag)
9. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CPR-UNI9
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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