Effects of Occupational Therapy in COPD (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Occupational therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring exacerbation, functionality, occupational therapy, chronic obstructive pulmonary disease
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion
Exclusion Criteria:
- Heart disease.
- Neurological patients.
- Contraindications of physiotherapy.
- Nursing home residents.
- Cognitive impairments.
Sites / Locations
- Department of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Occupational therapy group
Control group
Arm Description
35 patients diagnosed with chronic obstructive pulmonary disease attending to the Hospital because of an exacerbation are going to be included in this group.
35 patients diagnosed with chronic obstructive pulmonary disease are going to be included in this group. They are not going to receive other than standard care (medical and physical therapy intervention).
Outcomes
Primary Outcome Measures
Functionality
Change from baseline to postintervention on functionality. This is assessed using two measures: the Functional Independence Measure and the Canadian Occupational Performance Measure. A follow-up is going to be performed at 1, 3, 6 and 12 months after the occupational therapy intervention.
Quality of life
Changes from baseline to postintervention in quality of life. It is assessed using two questionnaires, the EuroQoL-5D questionnaire and the Health Questionnaire St. George. A follow-up is going to be performed at 1, 3, 6 and 12 months after treatment.
Secondary Outcome Measures
Anxiety and depression
Changes from baseline to postintervention on anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to complete this questionnaire composed of statements relevant to either generalised anxiety or depression. A follow-up is going to be performed at 1, 3, 6, and 12 months after the intervention.
Activity levels
The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours. A follow-up at 1, 3, 6 and 12 months is going to be performed after treatment.
Dyspnoea
Changes from baseline to postintervention in dyspnoea measured with Borg Scale. A follow-up is going to be performed at 1, 3, 6 and 12 months after occupational therapy treatment.
Full Information
NCT ID
NCT01994915
First Posted
November 20, 2013
Last Updated
November 1, 2016
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT01994915
Brief Title
Effects of Occupational Therapy in COPD
Acronym
COPD
Official Title
Effects on Functionality of Occupational Therapy Added to Physiotherapy in Severe COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
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 is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study is that an occupational therapy intervention added to a physiotherapy program and a medical treatment increase the functionality and the quality of life of patients with chronic obstructive pulmonary disease.
Detailed Description
The evolution of chronic obstructive pulmonary disease can be aggravated in some periods by an increase of the symptoms (above all, the cough, the dyspnea and the quantity of sputum purulence). This is known as exacerbation, and it is the most frequent reason for hospital stay, urgences services and death in this condition. A physiotherapy program and an occupational therapy intervention are carrying out in patients attending to the Hospital because of an exacerbation.. Participants will be assessed at baseline and again at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
exacerbation, functionality, occupational therapy, chronic obstructive pulmonary disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Occupational therapy group
Arm Type
Experimental
Arm Description
35 patients diagnosed with chronic obstructive pulmonary disease attending to the Hospital because of an exacerbation are going to be included in this group.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
35 patients diagnosed with chronic obstructive pulmonary disease are going to be included in this group. They are not going to receive other than standard care (medical and physical therapy intervention).
Intervention Type
Other
Intervention Name(s)
Occupational therapy
Other Intervention Name(s)
Activities of daily living, Functionality, Quality of life, Independence
Intervention Description
Patients included in this group are going to receive an occupational therapy intervention 3 sessions after hospital discharge. The intervention is based on energy conservation techniques improving the execution of the activities of daily living.
Primary Outcome Measure Information:
Title
Functionality
Description
Change from baseline to postintervention on functionality. This is assessed using two measures: the Functional Independence Measure and the Canadian Occupational Performance Measure. A follow-up is going to be performed at 1, 3, 6 and 12 months after the occupational therapy intervention.
Time Frame
Baseline, 12 months
Title
Quality of life
Description
Changes from baseline to postintervention in quality of life. It is assessed using two questionnaires, the EuroQoL-5D questionnaire and the Health Questionnaire St. George. A follow-up is going to be performed at 1, 3, 6 and 12 months after treatment.
Time Frame
Baseline, 12months
Secondary Outcome Measure Information:
Title
Anxiety and depression
Description
Changes from baseline to postintervention on anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to complete this questionnaire composed of statements relevant to either generalised anxiety or depression. A follow-up is going to be performed at 1, 3, 6, and 12 months after the intervention.
Time Frame
Baseline, 12 months
Title
Activity levels
Description
The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours. A follow-up at 1, 3, 6 and 12 months is going to be performed after treatment.
Time Frame
Baseline, 12 months
Title
Dyspnoea
Description
Changes from baseline to postintervention in dyspnoea measured with Borg Scale. A follow-up is going to be performed at 1, 3, 6 and 12 months after occupational therapy treatment.
Time Frame
baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation.
No contraindication of physiotherapy.
Signed written consent.
Medical approval for inclusion
Exclusion Criteria:
Heart disease.
Neurological patients.
Contraindications of physiotherapy.
Nursing home residents.
Cognitive impairments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effects of Occupational Therapy in COPD
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