Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

NCT01826682 | Completed DMC

• 1 other identifier: DF0039UG
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea and the quantity of sputum purulence). This is known as exacerbation and it is the most frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy program is carrying out in patients attending to the Hospital because of an exacerbation. The hypothesis of this study is that a physiotherapy program added to a medical treatment increase the ventilatory function, the physiques variables, decrease depression and anxiety and improve the quality of life. Additionally, it is going to be assessed the effect of physiotherapy in time using phone calls and visits to the patient's home.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, physiotherapy, exacerbation

Outcome Measures

Primary Outcomes (1)

• Strength in upper and lower limbs

  Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved was used in the analyses. This is important in order to quantify the increase of strength Kg/cm2 The test 2-minute step in place is also going to be used for this purpose, counting the times the patients go up the right knees in two minutes.

  baseline, 12 months

Secondary Outcomes (6)

• Changes in quality of life

  baseline, 12 months

• Respiratory parameters

  baseline, 12 months

• Activity monitoring

  baseline

• Performance of Physical activity

  baseline

• Changes in quality of sleep

  baseline, 12 months

Study Arms (2)

Medical treatment

PLACEBO COMPARATOR

29 people are being recruited in order to the inclusion criteria for the study. Placebo controlled.

Other: Medical treatment

Physiotherapy program+medical treatment

ACTIVE COMPARATOR

29 people are recruited in order to the inclusion criteria for the study. Experimental group

Other: Physiotherapy program+medical treatment

Interventions

Physiotherapy program+medical treatment OTHER

Patients included in this group are going to receive physiotherapy during their hospital stay 45 minutes every day. The physical training is based on respiratory exercises, the use of a flutter (positive expiratory pressure), pedaling and theraband exercises.

Also known as: Physiotherapy, Respiratory exercises, Strength exercises

Physiotherapy program+medical treatment

Medical treatment OTHER

Standard medical treatment without physiotherapy.

Also known as: Drugs

Medical treatment

Eligibility Criteria

• Age: 18 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:

• Heart disease.
• Neurological patients.
• Contraindications of physiotherapy.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

Related Publications (2)

• Torres-Sanchez I, Valenza MC, Cabrera-Martos I, Lopez-Torres I, Benitez-Feliponi A, Conde-Valero A. Effects of an Exercise Intervention in Frail Older Patients with Chronic Obstructive Pulmonary Disease Hospitalized due to an Exacerbation: A Randomized Controlled Trial. COPD. 2017 Feb;14(1):37-42. doi: 10.1080/15412555.2016.1209476. Epub 2016 Aug 11.

  PMID: 27715322 BACKGROUND

• Valenza MC, Valenza-Pena G, Torres-Sanchez I, Gonzalez-Jimenez E, Conde-Valero A, Valenza-Demet G. Effectiveness of controlled breathing techniques on anxiety and depression in hospitalized patients with COPD: a randomized clinical Trial. Respir Care. 2014 Feb;59(2):209-15. doi: 10.4187/respcare.02565. Epub 2013 Jul 23.

  PMID: 23882107 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Physical Therapy Modalities; Breathing Exercises; 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)

Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques

Study Officials

• Marie Carmen Valenza, PT, 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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 8, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)