Effects of Occupational Therapy in COPD
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effects on Functionality of Occupational Therapy Added to Physiotherapy in Severe COPD Patients|
- Functionality [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: Baseline, 12months ] [ Designated as safety issue: Yes ]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.
- Anxiety and depression [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: baseline, 12 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
Other: Occupational therapy
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.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01994915
|Contact: Marie Carmen Valenza, PhDfirstname.lastname@example.org|
|Department of Physical Therapy||Recruiting|
|Granada, Spain, 18071|
|Contact: Marie Carmen Valenza, PhD 958242360 email@example.com|
|Principal Investigator: Marie Carmen Valenza, PhD|
|Principal Investigator:||Marie Carmen Valenza, PhD||Universidad de Granada|