- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02509299
Effect of Physiotherapy in Hospitalized COPD Patients
Effect of Different Physiotherapy Treatments in Hospitalized COPD Patients
Chronic obstructive pulmonary disease (COPD) impacts negatively on the balance and strength of patients. Several studies have shown that acute exacerbations (AEs) decrease, pulmonary function and survival of COPD patients, and there are a lot of physiotherapy interventions to improve it during the hospital stay.
The objective of the present study is to examine the effects of a physical therapy program on balance and strength in COPD patients hospitalized due to acute exacerbation.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. It is a progressive disease, characterized by lung function impairment with airway obstruction.
Patients with COPD suffer exacerbations; the frequency of these exacerbations increases with the severity of the disease. It has been previously shown that the level of health-related quality of life of COPD subjects deteriorates considerably with increasing severity of disease and that the deterioration is linearly related to a decrease in FEV1 % predicted normal values.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Granada, Spania, 18071
- Department of Physical Therapy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- COPD diagnosis with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion.
Exclusion Criteria:
- Contraindications for physiotherapy
- Neurological, orthopedic or heart disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Experimental group 1
patients will be involved in the Physiotherapy program 1.
The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises.
The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises added to standard treatment.
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The standard medical treatment and additionally they will receive physiotherapy.
The program will be performed every day during the hospital stay and it will include global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises.
Andre navn:
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Eksperimentell: Experimental group 2
patients will be involved in the physiotherapy program 2. The program was a combined intervention including the Control Group treatment plus neuromuscular stimulation therapy on quadriceps accompanied by lower limb exercises.
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COPD patients included in this group will receive the standard medical treatment and additionally, they will receive a physiotherapy program.
The program will be performed every day during the hospital stay and included neuromuscular stimulation therapy on quadriceps accompanied by lower limbs exercises
Andre navn:
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Annen: Control group
patients will receive standard medical treatment without physiotherapy intervention.
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The standard medical treatment consists on:
Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria. - Antibiotics: The antibiotics were administered according to the GOLD criteria including the β-lactamase inhibitor and fluoroquinolones.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Lower limb strength
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Lower limb strength was evaluated by a dynamometer.
The assessor placed the limb to be examined in the starting position (a knee flexion of 90º) and instructed each participant to hold the limb in that position against the increasing resistance applied to it by the examiner.
During each test the assessor counted out loud for seconds and at the end of the test period advised the participant to relax the limb.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Balance
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Balance was evaluated by the one-leg standing balance test, that measured the time that the patient balance on one leg as long as possible.
We asked the subject being tested to choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg as long as possible
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Respiratory function
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Spirometry is regarded as the gold standard measure of respiratory function.
The indicators of forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) will be tested.
Spirometry will be performed according to American Thoracic Society (ATS) criteria.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Anxiety and depression
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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The hospital anxiety and depression scale (HADS) will be used to evaluate psychological status.
HADS is a 14-items self-report questionnaire designed to detect psychological morbidity in medically ill patients.
It contains depression and anxiety subscales, each with scores ranging from 0 to 21.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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