- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01994915
Effects of Occupational Therapy in COPD (COPD)
November 1, 2016 updated by: Marie Carmen Valenza, Universidad de Granada
Effects on Functionality of Occupational Therapy Added to Physiotherapy in Severe COPD Patients
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Granada, Spain, 18071
- Department of Physical Therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Occupational therapy group
35 patients diagnosed with chronic obstructive pulmonary disease attending to the Hospital because of an exacerbation are going to be included in this group.
|
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.
Other Names:
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NO_INTERVENTION: Control 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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functionality
Time Frame: Baseline, 12 months
|
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.
|
Baseline, 12 months
|
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Quality of life
Time Frame: Baseline, 12months
|
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.
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Baseline, 12months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety and depression
Time Frame: Baseline, 12 months
|
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.
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Baseline, 12 months
|
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Activity levels
Time Frame: Baseline, 12 months
|
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.
|
Baseline, 12 months
|
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Dyspnoea
Time Frame: baseline, 12 months
|
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.
|
baseline, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ANTICIPATED)
December 1, 2016
Study Completion (ANTICIPATED)
July 1, 2017
Study Registration Dates
First Submitted
November 20, 2013
First Submitted That Met QC Criteria
November 20, 2013
First Posted (ESTIMATE)
November 26, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0045UG
- FCSDP1010 (OTHER: Department of Physical Therapy)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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