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Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease

30. oktober 2016 opdateret af: Marie Carmen Valenza, Universidad de Granada

Effects of a Physiotherapy Program in Patients With Stable Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by incompletely reversible airflow obstruction. It is projected to be the fifth leading burden of disease worldwide by the year 2020. Pulmonary dysfunction reduces exercise capacity in COPD patients, and it has been previously shown that COPD patients suffer deterioration in their quality of life. The objective of this study is to examine the effects of a physical therapy intervention in stable patients with COPD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Chronic obstructive pulmonary disease (COPD) is one of the leading diseases causing mortality and morbidity, despite advanced pharmacotherapy and therapeutic management. Although COPD primarily affects the lungs, it also implies extrapulmonary manifestations, such as nutritional depletion, skeletal muscle dysfunction, and abnormal respiratory muscles.

Pulmonary rehabilitation is widely used to treat COPD patients and it has been shown that pulmonary rehabilitation should be implemented at all COPD stages, bringing them benefits in terms of improved exercise capacity, symptoms, and quality of life.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Granada, Spanien, 18071
        • Department of Physical Therapy

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • COPD diagnosis
  • No contraindication of physiotherapy.
  • Signed written consent.
  • Medical approval for inclusion.

Exclusion Criteria:

  • Acute exacerbation in the previous month
  • Contraindications of physiotherapy.
  • Neurological, orthopedic or heart disease.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group
COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.
Andet: Physiotherapy added to standard care
The treatment will be based on domiciliary physiotherapy program during 8 weeks, twice a week added to standard care. The duration of the sessions will be 45-60 minutes. The physiotherapy treatment includes: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband. This will be a home-based program supervised by a physiotherapist.
Andre navne:
  • Fysioterapi
  • Home-based program
  • Domiciliary physiotherapy
Andet: Control group
COPD patients with stable disease will be recruited and they will receive standard care.
Andet: Standard care
The standard care of stable COPD is based on long-acting bronchodilators (LABD).
Andre navne:
  • standardbehandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Muscle strength
Tidsramme: Baseline, 8 weeks
Quadriceps strength will be assessed with a portable dynamometer.
Baseline, 8 weeks
Changes in Exercise capacity
Tidsramme: Baseline, 8 weeks
Five times sit to stand test (5STS) will be used to assess exercise capacity, 5STS is a simple assessment tool that is feasible in all healthcare settings, and may be a rapid method of assessing changes in exercise capacity in COPD and screening for poor physical functioning individuals.
Baseline, 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Respiratory function
Tidsramme: Baseline, 8 weeks
Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society (ATS) criteria.
Baseline, 8 weeks
Changes in Dyspnea perception
Tidsramme: Baseline, 8 weeks
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Baseline, 8 weeks
Changes in Quality of life
Tidsramme: Baseline, 8 weeks
EuroQol-5D (EQ-5D) will be used to assess quality of life. EQ-5D is a generic questionnaire and consists of two parts, the EQ-5D Visual analogue scale (VAS) and the EQ-5D index. The EQ-5D VAS consists on a vertical rating scale from 0 to 100 (0 = death/worst possible health state and 100 = best possible health state). The EQ-5D index is a five-item questionnaire (mobility, self-care, usual activity, pain/discomfort and anxiety/depression).
Baseline, 8 weeks
Changes in Fatigue
Tidsramme: Baseline, 8 weeks
Fatigue will be assessed with the Fatigue Severity Scale (FSS). The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them.
Baseline, 8 weeks
Impact of COPD
Tidsramme: Baseline, 8 weeks
The impact of COPD in patient's life will be evaluated with COPD Assessment Test (CAT) that is a simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice.
Baseline, 8 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life related to respiratory symptoms
Tidsramme: Baseline
Saint George Respiratory Questionnaire (SGRQ) will be also used to evaluate the quality of life of patients in the previous year. It includes 50 items, divided into three domains: Symptoms, Activity and Impacts. A score is calculated for each domain and a total score including all items is also obtained. Low scores indicate better health related quality of life.
Baseline
Peripheral vascular status
Tidsramme: Baseline
Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.
Baseline
Physical activity
Tidsramme: Baseline
Modified Baecke Questionnaire will be used to assess the physical activity levels. It is a frequently used questionnaire to measure habitual physical activity in the elderly.
Baseline
Cognitive status
Tidsramme: Baseline
Cognitive status will be assessed with Montreal Cognitive Assessment test (MoCA) which is a cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Granada

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

2. august 2015

Først indsendt, der opfyldte QC-kriterier

4. august 2015

Først opslået (Skøn)

7. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DF0058UG

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Kliniske forsøg med KOL

Kliniske forsøg med Physiotherapy added to standard care

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