NCT01994915

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

November 20, 2013

Last Update Submit

November 1, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

exacerbationfunctionalityoccupational therapychronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • Anxiety and depression

    Baseline, 12 months

  • Activity levels

    Baseline, 12 months

  • Dyspnoea

    baseline, 12 months

Study Arms (2)

Occupational therapy group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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).

Interventions

Occupational therapyOTHER

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.

Also known as: Activities of daily living, Functionality, Quality of life, Independence
Occupational therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation.
  • No contraindication of physiotherapy.
  • Signed written consent.

You may not qualify if:

  • Heart disease.
  • Neurological patients.
  • Contraindications of physiotherapy.
  • Nursing home residents.
  • Cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, Spain, 18071, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Occupational TherapyActivities of Daily LivingQuality of Life

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(1)