Effects of Occupational Therapy in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD  

Official title:

Effects on Functionality of Occupational Therapy Added to Physiotherapy in Severe COPD Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01994915
• Other study ID #: DF0045UG
• Secondary ID: FCSDP1010
• Status: Active, not recruiting
• Phase: N/A
• First received: November 20, 2013
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 months	Yes
Primary	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.	Baseline, 12months	Yes
Secondary	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.	Baseline, 12 months	Yes
Secondary	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.	Baseline, 12 months	Yes
Secondary	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.	baseline, 12 months	Yes