- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02468635
Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease (PR)
keskiviikko 24. toukokuuta 2017 päivittänyt: Cássio Magalhães da Silva e Silva, Federal University of Bahia
Analysis of Pulmonary Rehabilitation on the Physical Capacity and Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease Clinical Trial
Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not fully reversible airway, where the severity of the disease and the prognosis is not determined solely by changes in lung function.
Pulmonary rehabilitation is a multidisciplinary program of care for patients with chronic respiratory diseases, individually designed to optimize physical and social performance and autonomy of these patients, promoting improvement in functional exercise capacity, quality of life, reducing dyspnea, frequency and duration of hospitalizations and reduce the frequency of exacerbations of the disease.
The overall objective of the research is to evaluate the effects of pulmonary rehabilitation program on exercise capacity, lung function, quality of daily life and reduction of dyspnea in patients with COPD.
A study type randomized, open-label trial following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials) will be held.
The study will be conducted at the Clinic Physiotherapy Course of the School with a sample of 58 patients.
The intervention will be performed sessions three times a week for 16 weeks (8 weeks for assessment and 8 weeks for adaptation and (pulmonary rehabilitation training).
The PR (pulmonary rehabilitation) will last 60-120 minutes each.O group A (control) will receive treatment of traditional pulmonary rehabilitation and without resistive training for upper limb (UL) and group B will receive the same treatment control with additional training of upper limb strength.
Tutkimuksen yleiskatsaus
Tila
Tuntematon
Interventio / Hoito
Yksityiskohtainen kuvaus
Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not fully reversible airway, where the severity of the disease and the prognosis is not determined solely by changes in lung function.
Pulmonary rehabilitation is a multidisciplinary program of care for patients with chronic respiratory diseases, individually designed to optimize physical and social performance and autonomy of these patients, promoting improvement in functional exercise capacity, quality of life, reducing dyspnea, frequency and duration of hospitalizations and reduce the frequency of exacerbations of the disease.
It is still reported in the survey improved ability to perform activities of daily life, exercise capacity, quality of life, reduction in respiratory symptoms, anxiety and depression in patients with chronic lung diseases.
The overall objective of the research is to evaluate the effects of pulmonary rehabilitation program on exercise capacity, lung function, quality of daily life and reduction of dyspnea in patients with COPD.
A study type randomized, open-label trial following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials) will be held.
The study will be conducted at the Clinical Department of Physical Therapy School The calculation of the sample held at LEE program (epidemiology laboratory and statistics) with 95% confidence interval and allowing a loss of 20% the sample then goes to 58 patients.
Inclusion criteria: Patients with COPD eligible to moderate COPD according to the criteria of gold GOLD (Global Initiative for Chronic Obstructive Lung Disease) as well as being ex-smokers and no exacerbation of the disease in the last three months.
Accompanied by a pulmonologist.
Age between 40-85 years.
Be not practicing physical activity and without cardiovascular or orthopedic disease, make use of bronchodilators and oral theophylline, oxygen therapy or corticosteroids.
Exclusion criteria: Patients who have comorbidities musculoskeletal, peripheral saturation of oxygen fall lower than 90% during the 6 minute walk test (six) minutes.
Difficulty cognitive understanding of body awareness.
The evaluation procedure will be: functional independence measure (FIM); london chest activity of daily living (LCADL); scale medical research council (MRC); the world health organization disability assessment schedule 2.0 (WHODAS 2.0); anthropometric examination; walk test of six (6) minutes; step test; As the repetition maximum (RM); muscle activation - electromyography; grip strength of the upper limbs (DMS); ultrasound diaphragm dynamometer; spirometry; respiratory muscle strength; saint george in respiratory disease questionnaire (SGRQ).
The intervention will be performed sessions three times a week for 16 weeks (8 weeks for assessment and 8 weeks for adaptation and PR training).
PR will last from 60 to 120 minutes each.
Patients who agree to participate and the PR will be divided into two groups randomly through enveloped draw.
Group A (control) will receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL) and group B will receive the same treatment control with additional upper limb resistance training.
For data analysis continuous variables will be analyzed with central tendency and dispersion measures, data or dichotomous categorical variables will be analyzed frequently measures.
For the realization of inferential statistics are.
Since the data are normally distributed, the Student t test for independent samples.
The Mann-Whitney test is used to compare the differences in the means of the variables between the groups.
To analyze the correlation between the functional capacity variables and QOL will be used in calculating the Pearson correlation coefficient (r) if the data are normally distributed and the calculation of the Spearman correlation coefficient was not distributed normally.
To evaluate the reliability will be used the coefficient of intra-class correlation coefficient (ICC).
Statistical analysis will be performed using the Statistical Package for Social Sciences for Windows (version 17.0).
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
2
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Bahia
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Salvador, Bahia, Brasilia, 40110100
- Rekrytointi
- Federal University of Bahia
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Ottaa yhteyttä:
- Cássio Magalhães, research
- Puhelinnumero: +557199616304
- Sähköposti: cassiofisio2@yahoo.com.br
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Ottaa yhteyttä:
- Mansueto Neto, research
- Puhelinnumero: +557199188277
- Sähköposti: netofisio@gmail.com
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
40 vuotta - 85 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Patients with COPD eligible to moderate COPD according to the criteria of gold GOLD (Global Initiative for Chronic Obstructive Lung Disease) and who had post-bronchodilator spirometry results in the last year of FEV1 (forced expiratory volume in one second) / FVC (forced vital capacity) <0.7 and FEV1 between 50% and 80% of previsto.
- Besides being former smokers for at least three months and were clinically stable, no disease exacerbation in the past three months.
- Accompanied by a pulmonologist.
- Age between 40-85 years.
- They are not practicing physical activity.
- Without cardiovascular or orthopedic disease that makes it impossible to perform the exercises of the RP protocol.
- Without presenting other comorbidities that put them at risk during the exercises .
- Use of bronchodilators and oral theophylline, oxygen therapy or corticosteroids.
Exclusion Criteria:
- Patients who have musculoskeletal comorbidities that interfere with walking or performing upper extremity exercises.
- lower peripheral saturation decrease of oxygen lower than 90% during the 6 minute walk test (six) minutes.
- Presenting difficulty of cognitive understanding of body awareness and the ability to recall information for the questionnaire responses applied in the evaluation and re-evaluation in addition to this also children, adolescents and legally incapable
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Muut: without training for upper limb
Receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL)
|
HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes).
AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESPIRATORY TRAINING: Strengthening respiratory muscles 5-15 minutes with Threshold with load of 50% of MIP hit in the evaluation.
RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.
|
|
Muut: upper limb exercises
Receive the same treatment control with additional upper limb resistance training.
|
HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes).
AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESISTANCE STAGE: upper limb exercises with weight training equipment or dumbbells (the patient's adaptation) with 50% of maximum load reached the maximum repetition test.
Series 2 minutes and rest interval between sets 1-2 minutes.
RESPIRATORY TRAINING : Strengthening of the respiratory muscles 5-15 minutes with Threshold with load of 50% of the affected MIP (measure maximal inspiratory pressure) evaluation.
RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in distance of the six-minute walk test
Aikaikkuna: 8 weeks
|
measure: metres
|
8 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in quality of life
Aikaikkuna: 8 weeks
|
measured by questionnaire Saint George/ measure: points
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8 weeks
|
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Change in forced expiratory volume in one second
Aikaikkuna: 8 weeks
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measurement: liters
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8 weeks
|
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Change in forced vital capacity
Aikaikkuna: 8 weeks
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measurement: liters
|
8 weeks
|
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Change in respiratory muscle strength
Aikaikkuna: 8 weeks
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measurement: Water centimeter
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8 weeks
|
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repetition maximum (RM);
Aikaikkuna: 8 weeks
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measurement: Kg
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8 weeks
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Adelmir Machado, research, Federal University of Bahia
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. kesäkuuta 2015
Ensisijainen valmistuminen (Odotettu)
Torstai 1. kesäkuuta 2017
Opintojen valmistuminen (Odotettu)
Tiistai 1. toukokuuta 2018
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Lauantai 30. toukokuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 8. kesäkuuta 2015
Ensimmäinen Lähetetty (Arvio)
Torstai 11. kesäkuuta 2015
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 30. toukokuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 24. toukokuuta 2017
Viimeksi vahvistettu
Maanantai 1. toukokuuta 2017
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ca141078
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