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Effects of Occupational Therapy in COPD

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01994915
First received: November 20, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Occupational therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 35
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Activities of daily living
  • Functionality
  • Quality of life
  • Independence
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994915

Contacts
Contact: Marie Carmen Valenza, PhD 958242360 cvalenza@ugr.es

Locations
Spain
Department of Physical Therapy Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD    958242360    cvalenza@ugr.es   
Principal Investigator: Marie Carmen Valenza, PhD         
Sponsors and Collaborators
Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01994915     History of Changes
Other Study ID Numbers: DF0045UG, FCSDP1010
Study First Received: November 20, 2013
Last Updated: January 27, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
exacerbation
functionality
occupational therapy
chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014