Effect of Physiotherapy in Hospitalized COPD Patients

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Physiotherapy program 2; Other: Physiotherapy program 1; Drug: Standard medical treatment

• Registration Number: NCT02509299
• Lead Sponsor: Universidad de Granada

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-07-19
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-28
• Study Start: 2019-09-01
• Primary Completion: 2019-11-20
• Study Completion: 2019-12-14
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 2	Physiotherapy program 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.
Experimental group 1	Physiotherapy program 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.
Control group	Standard medical treatment	patients will receive standard medical treatment without physiotherapy intervention.

Primary Outcome Measures

Name	Time	Method
Lower limb strength	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.
Balance	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 Outcome Measures

Name	Time	Method
Respiratory function	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.
Anxiety and depression	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.

Trial Locations

Locations (1)

Department of Physical Therapy; 🇪🇸 Granada, Spain