Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease
30. oktober 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
40
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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Granada, Spania, 18071
- Department of Physical Therapy
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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
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Experimental group
COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.
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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 navn:
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Annen: Control group
COPD patients with stable disease will be recruited and they will receive standard care.
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The standard care of stable COPD is based on long-acting bronchodilators (LABD).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in Muscle strength
Tidsramme: Baseline, 8 weeks
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Quadriceps strength will be assessed with a portable dynamometer.
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Baseline, 8 weeks
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Changes in Exercise capacity
Tidsramme: Baseline, 8 weeks
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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.
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Baseline, 8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in Respiratory function
Tidsramme: Baseline, 8 weeks
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Spirometry is regarded as the gold standard measure of respiratory function.
Spirometry will be performed according to the American Thoracic Society (ATS) criteria.
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Baseline, 8 weeks
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Changes in Dyspnea perception
Tidsramme: Baseline, 8 weeks
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Dyspnea perception will be assessed with Borg modified scale.
Patients will classify their breathlessness between 0 and 10.
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Baseline, 8 weeks
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Changes in Quality of life
Tidsramme: Baseline, 8 weeks
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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).
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Baseline, 8 weeks
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Changes in Fatigue
Tidsramme: Baseline, 8 weeks
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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.
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Baseline, 8 weeks
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Impact of COPD
Tidsramme: Baseline, 8 weeks
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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.
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Baseline, 8 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Quality of life related to respiratory symptoms
Tidsramme: Baseline
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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.
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Baseline
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Peripheral vascular status
Tidsramme: Baseline
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Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.
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Baseline
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Physical activity
Tidsramme: Baseline
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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.
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Baseline
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Cognitive status
Tidsramme: Baseline
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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.
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Baseline
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. september 2015
Primær fullføring (Faktiske)
1. januar 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
2. august 2015
Først innsendt som oppfylte QC-kriteriene
4. august 2015
Først lagt ut (Anslag)
7. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. oktober 2016
Sist bekreftet
1. oktober 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DF0058UG
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
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