Effect of Physiotherapy in Hospitalized COPD Patients

COPD Clinical Trial

Official title:

Effect of Different Physiotherapy Treatments in Hospitalized COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509299
• Other study ID #: DF0055UG
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 14, 2019

Study information

• Verified date: January 2020
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 14, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Physiotherapy program 1
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.
• Physiotherapy program 2
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

Drug:
• Standard medical treatment
The standard medical treatment consists on: Inhaled bronchodilators: Short acting inhaled ß2 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 ß-lactamase inhibitor and fluoroquinolones.

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb strength	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.
Primary	Balance	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.
Secondary	Respiratory function	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.
Secondary	Anxiety and depression	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.