Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT02515318 | Unknown DMC

• 1 other identifier: DF0056UG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is projected to be the fifth leading burden of disease worldwide by the year 2020. An acute exacerbation of COPD (AECOPD) is defined as an acute event characterized by a worsening of the patient's respiratory symptoms that requires a modification in the medication. AECOPD are frequent (mean of 1-4 exacerbations each year). It increases in frequency with the severity of the disease. The objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients with COPD during hospitalization due to an acute exacerbation.

Conditions

COPD

Keywords

COPD; Exacerbation; Hospitalisation; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• Muscle strength

  Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported

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

• Exercise capacity

  Five times sit to stand test (5STS) will be used to assess exercise capacity, 5STS is a simple assessment tool that is feasible in all healthcare settings, and may be a rapid method of assessing changes in exercise capacity in COPD and screening for poor physical functioning individuals.

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

Secondary Outcomes (5)

• Respiratory function

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

• Dyspnea

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

• Health status

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

• Fatigue

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

• Impact of COPD

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

Other Outcomes (2)

• Dependency levels

  Baseline

• Comorbidities

  Baseline

Study Arms (2)

Physiotherapy program

EXPERIMENTAL

Patients with COPD are included in this group. They will receive a physiotherapy program during the hospitalization due to acute exacerbation of COPD, additionally to the standard medical treatment

Other: Physiotherapy program

Control group

ACTIVE COMPARATOR

Patients with COPD are included in this group. They will receive the medical standard treatment during the hospitalization due to acute exacerbation of COPD.

Drug: Medical standard treatment

Interventions

Physiotherapy program OTHER

The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes, and included: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.

Also known as: Respiratory exercises, Electrostimulation

Physiotherapy program

Medical standard 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:

• Neurological, orthopedic or heart diseases.
• Prosthetic devices in the lower limbs.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (2)

University of Granada

Granada, 18016, Spain

RECRUITING

Department of Physical Therapy

Granada, 18071, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Breathing Exercises; Transcutaneous Electric Nerve Stimulation; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Electric Stimulation Therapy; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Marie Carmen Valenza, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Carmen Valenza, PhD

CONTACT

958 248035; cvalenza@ugr.es

Study Design

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

Study Record Dates

• First Submitted: August 1, 2015
• First Posted: August 4, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

ES (2)