ClinicalTrials.gg
Status unknownNCT01994915COPDUpdated Nov 2, 2016

Effects of Occupational Therapy in COPD

An interventional study of Occupational therapy in Chronic Obstructive Pulmonary Disease, sponsored by Universidad de Granada. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • exacerbation
  • functionality
  • occupational therapy
  • chronic obstructive pulmonary disease
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 35 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 244 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Heart disease.
  • Neurological patients.
  • Contraindications of physiotherapy.
  • Nursing home residents.
  • Cognitive impairments.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
35 participants (estimated)

Study arms

  • 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

  • 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).

Interventions

  • OtherOccupational 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.

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 12 months

  2. 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.

    Time frame: Baseline, 12months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 12 months

  2. 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.

    Time frame: Baseline, 12 months

  3. 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.

    Time frame: baseline, 12 months

07

Study locations

1 site
  • Department of Physical Therapy
    Granada, Spain 18071, Spain
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Dec 2016 and a completion of Jul 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2013
First posted
Nov 26, 2013
Start
Dec 2013
Primary completionEst.
Dec 2016
CompletionEst.
Jul 2017
Last update
Nov 2, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01994915
Responsible party
Marie Carmen Valenza (assistant professor, Universidad de Granada) — Principal investigator
First posted
Nov 26, 2013
Start date
Dec 2013
Primary completion
Dec 2016 (estimated)
Completion
Jul 2017 (estimated)
Last update
Nov 2, 2016

Study contacts

Marie Carmen Valenza, PhD
principal investigator · Universidad de Granada

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion