Chronic Obstructive Pulmonary DiseaseCOPDNCT01994915
Effects of Occupational Therapy in COPD
A study testing Occupational therapy in people with Chronic Obstructive Pulmonary Disease, run by Universidad de Granada at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion
Who cannot join
- Heart disease.
- Neurological patients.
- Contraindications of physiotherapy.
- Nursing home residents.
- Cognitive impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Functionality of Occupational Therapy Added to Physiotherapy in Severe COPD Patients
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Occupational therapy
- Keywords
- exacerbation, functionality, occupational therapy, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapyOther
Also called Activities of daily living, Functionality, Quality of life, Independence
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 12months
Secondary outcomes (3)
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.
Measured: Baseline, 12 months
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.
Measured: Baseline, 12 months
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.
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994915
- Sponsor's protocol ID
- DF0045UG
- Other IDs
- FCSDP1010
- Acronym
- COPD
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Functionality of Occupational Therapy Added to Physiotherapy in Severe COPD Patients
- ClinicalTrials.gov ID
- NCT01994915
- Acronym / sponsor ID
- COPD / DF0045UG
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- exacerbation, functionality, occupational therapy, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy group | Experimental | Other: Occupational therapy35 patients diagnosed with chronic obstructive pulmonary disease attending to the Hospital because of an exacerbation are going to be included in this group. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion
Key exclusion criteria (5 listed)
- Heart disease.
- Neurological patients.
- Contraindications of physiotherapy.
- Nursing home residents.
- Cognitive impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational therapyAlso: Activities of daily living, Functionality, Quality of life, IndependencePatients 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 | Occupational therapy group |
Primary outcome
Functionality
Time frame: Baseline, 12 months
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
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.
3 secondary outcomes
Anxiety and depression
Time frame: Baseline, 12 months
Activity levels
Time frame: Baseline, 12 months
Dyspnoea
Time frame: baseline, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Recruiting
Study on Impact of Maximal Strength Training in Patients With COPD
Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy in people with Chronic Obstructive Pulmonary Disease, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality (time frame: Baseline, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.