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Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy program+medical treatment
Medical treatment
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, physiotherapy, exacerbation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD diagnosis with exacerbation.
  • No contraindication of physiotherapy.
  • Signed written consent.
  • Medical approval for inclusion.

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Health Sciences. University of Granada.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Medical treatment

Physiotherapy program+medical treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in quality of life
Changes from baseline to postintervention during hospital stay in quality of life associated with health. This is going to be measure with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George
Respiratory parameters
Changes from baseline to postintervention in respiratory parameters using a spirometer as recommended by the American Thoracic Society. The most important respiratory parameters evaluated are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), carbon dioxide partial pressure (PCO2) and oxygen partial pressure (PO2)
Activity monitoring
The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours.
Performance of Physical activity
The participants are going to complete the Baecke physical activity questionnaire-modified in order to describe their physical status at baseline.
Changes in quality of sleep
Changes in quality of sleep from baseline to postintervention. For this purpose, the participants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
Changes in anxiety and depression
Changes from baseline to postintervention in anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to completed this questionnaire composed of statements relevant to either generalised anxiety or depression.

Full Information

First Posted
March 28, 2013
Last Updated
November 2, 2016
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT01826682
Brief Title
Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease
Official Title
Physiotherapy Program Intervention in Exacerbation of Chronic Obstructive Pulmonary Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The benefits added to the respiratory physiotherapy and physical activity have been evidenced previously in the treatment of COPD. This justify the need of a short physiotherapy intervention program regarding to the hospital stay in exacerbation of COPD and a follow-up after the hospital stay. 4% of europeans have been reported to have medical intervention caused by respiratory exacerbation. 20% of these patients are patients with COPD. The mortality of COPD exacerbation is about 14% and 30% if mechanical ventilation is needed. In order to that, it is very important to improve the quality of life and the recuperation of patients. It is relevant to mention the the high cost associated to this condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, physiotherapy, exacerbation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical treatment
Arm Type
Placebo Comparator
Arm Description
29 people are being recruited in order to the inclusion criteria for the study. Placebo controlled.
Arm Title
Physiotherapy program+medical treatment
Arm Type
Active Comparator
Arm Description
29 people are recruited in order to the inclusion criteria for the study. Experimental group
Intervention Type
Other
Intervention Name(s)
Physiotherapy program+medical treatment
Other Intervention Name(s)
Physiotherapy, Respiratory exercises, Strength exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Medical treatment
Other Intervention Name(s)
Drugs
Intervention Description
Standard medical treatment without physiotherapy.
Primary Outcome Measure Information:
Title
Strength in upper and lower limbs
Description
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.
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Changes in quality of life
Description
Changes from baseline to postintervention during hospital stay in quality of life associated with health. This is going to be measure with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George
Time Frame
baseline, 12 months
Title
Respiratory parameters
Description
Changes from baseline to postintervention in respiratory parameters using a spirometer as recommended by the American Thoracic Society. The most important respiratory parameters evaluated are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), carbon dioxide partial pressure (PCO2) and oxygen partial pressure (PO2)
Time Frame
baseline, 12 months
Title
Activity monitoring
Description
The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours.
Time Frame
baseline
Title
Performance of Physical activity
Description
The participants are going to complete the Baecke physical activity questionnaire-modified in order to describe their physical status at baseline.
Time Frame
baseline
Title
Changes in quality of sleep
Description
Changes in quality of sleep from baseline to postintervention. For this purpose, the participants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
Time Frame
baseline, 12 months
Title
Changes in anxiety and depression
Description
Changes from baseline to postintervention in anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to completed this questionnaire composed of statements relevant to either generalised anxiety or depression.
Time Frame
baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD diagnosis with exacerbation. No contraindication of physiotherapy. Signed written consent. Medical approval for inclusion. Exclusion Criteria: Heart disease. Neurological patients. Contraindications of physiotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PT, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada.
State/Province
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27715322
Citation
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.
Results Reference
background
PubMed Identifier
23882107
Citation
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. Erratum In: Respir Care. 2016 Nov;61(11):e3.
Results Reference
derived

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Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

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