- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02468635
Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease (PR)
24. května 2017 aktualizováno: 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.
Přehled studie
Postavení
Neznámý
Podmínky
Intervence / Léčba
Detailní popis
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).
Typ studie
Intervenční
Zápis (Očekávaný)
2
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bahia
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Salvador, Bahia, Brazílie, 40110100
- Nábor
- Federal University of Bahia
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Kontakt:
- Cássio Magalhães, research
- Telefonní číslo: +557199616304
- E-mail: cassiofisio2@yahoo.com.br
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Kontakt:
- Mansueto Neto, research
- Telefonní číslo: +557199188277
- E-mail: netofisio@gmail.com
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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.
|
|
Jiný: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in distance of the six-minute walk test
Časové okno: 8 weeks
|
measure: metres
|
8 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in quality of life
Časové okno: 8 weeks
|
measured by questionnaire Saint George/ measure: points
|
8 weeks
|
|
Change in forced expiratory volume in one second
Časové okno: 8 weeks
|
measurement: liters
|
8 weeks
|
|
Change in forced vital capacity
Časové okno: 8 weeks
|
measurement: liters
|
8 weeks
|
|
Change in respiratory muscle strength
Časové okno: 8 weeks
|
measurement: Water centimeter
|
8 weeks
|
|
repetition maximum (RM);
Časové okno: 8 weeks
|
measurement: Kg
|
8 weeks
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Adelmir Machado, research, Federal University of Bahia
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. června 2015
Primární dokončení (Očekávaný)
1. června 2017
Dokončení studie (Očekávaný)
1. května 2018
Termíny zápisu do studia
První předloženo
30. května 2015
První předloženo, které splnilo kritéria kontroly kvality
8. června 2015
První zveřejněno (Odhad)
11. června 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. května 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. května 2017
Naposledy ověřeno
1. května 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ca141078
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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