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NCT Number: NCT02509299

Effect of Physiotherapy 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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy program 1

Other

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.

Other names: Global exercises

Physiotherapy program 2

Other

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

Other names: NEMS and lower limb exercises

Standard Medical Treatment

Drug

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.

Other names: Drugs

Primary outcomes

  1. Lower limb strength

    Time frame: 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.

  2. Balance

    Time frame: 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

Secondary outcomes

  1. Respiratory function

    Time frame: 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.

  2. Anxiety and depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Effect of Different Physiotherapy Treatments in Hospitalized COPD Patients

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2015
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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