Effect of Physiotherapy in Hospitalized COPD Patients

NCT02509299 | Completed DMC

• 1 other identifier: DF0055UG
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; NEMS

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Respiratory function

  Participants will be followed for the duration of hospital stay, an expected average of 9 days.

• Anxiety and depression

  Participants will be followed for the duration of hospital stay, an expected average of 9 days.

Study Arms (3)

Experimental group 1

EXPERIMENTAL

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.

Other: Physiotherapy program 1

Experimental group 2

EXPERIMENTAL

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.

Other: Physiotherapy program 2

Control group

OTHER

patients will receive standard medical treatment without physiotherapy intervention.

Drug: Standard medical treatment

Interventions

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.

Also known as: Global exercises

Experimental group 1

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

Also known as: NEMS and lower limb exercises

Experimental group 2

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.

Also known as: Drugs

Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD diagnosis with exacerbation.
• No contraindication of physiotherapy.
• Signed written consent.

You may not qualify if:

• Contraindications for physiotherapy
• Neurological, orthopedic or heart disease

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Department of Physical Therapy

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie Carmen Valenza, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 19, 2015
• First Posted: July 28, 2015
• Study Start: September 1, 2019
• Primary Completion: November 20, 2019
• Study Completion: December 14, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

ES (1)