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Effect of Physiotherapy in Hospitalized COPD Patients

22 januari 2020 uppdaterad av: Marie Carmen Valenza, Universidad de Granada

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

49

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Granada, Spanien, 18071
        • Department of Physical Therapy

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
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.
Andra namn:
  • Global exercises
Experimentell: 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.
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
Andra namn:
  • NEMS and lower limb exercises
Övrig: Control group
patients will receive standard medical treatment without physiotherapy intervention.

The standard medical treatment consists on:

  • Inhaled bronchodilators: Short acting inhaled β2 agonists ( salbutamol and terbutaline) and anticholinergic agents (ipratropium and oxitropium bromide).
  • Glucocorticoids:

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.

Andra namn:
  • Läkemedel

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Lower limb strength
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Balance
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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
Participants will be followed for the duration of hospital stay, an expected average of 9 days.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Respiratory function
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.
Anxiety and depression
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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.
Participants will be followed for the duration of hospital stay, an expected average of 9 days.

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2019

Primärt slutförande (Faktisk)

20 november 2019

Avslutad studie (Faktisk)

14 december 2019

Studieregistreringsdatum

Först inskickad

19 juli 2015

Först inskickad som uppfyllde QC-kriterierna

23 juli 2015

Första postat (Uppskatta)

28 juli 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 januari 2020

Senast verifierad

1 januari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • DF0055UG

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