Chronic Obstructive Pulmonary DiseaseTIMENCT01871025
Early Incentive and Mobilization During COPD Exacerbation
A study testing Hospital and home exercise training in people with Chronic Obstructive Pulmonary Disease, run by Parc de Salut Mar at 2 sites in Spain.
Trial summary
To study the effects of early exercise training in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Hospital and home exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2013to Mar 2018
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients for COPD exacerbation
Who cannot join
- Hospitalization within the previous 14 days,
- current participation in rehabilitation program,
- locomotor or neurological condition or disability limiting the ability to perform exercise,
- lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic i Provincial
Barcelona
Hospital de Sabadell
Sabadell, Barcelona
About this study
To study the effects of early exercise training in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both groups, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.
Read the detailed description
Prospective randomized study in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both group, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Hospital and home exercise training, Usual care
- Keywords
- 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.
Hospital and home exercise trainingOther
Hospital exercise training (aerobic and strength) followed by exercise training
Usual careOther
Also called Usual recommendations
Usual care includes respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations, but not exercise training
| Study group | Role | What they receive |
|---|---|---|
| Hospital and home exercise training | Experimental | Usual care plus hospital exercise training (aerobic and strength) followed by exercise training at home until 30 days to discharge. Receives: Other: Hospital and home exercise training |
| Usual care | Other | Usual care in COPD Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily physical activity
Increase 10% moderate and/or vigorous daily physical activities after discharge
Measured: 1 month
Secondary outcomes (3)
Tolerance to exercise
Six minutes walk test
Measured: 1 month
COPD Assessment Test (CAT)
Quality of life
Measured: 1 month
Physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2018
- Study completionMar 2018
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Agustín Rodríguez, Parc de Salut Mar
- Investigators
- Diego Rodriguez, MD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871025
- Sponsor's protocol ID
- 2012/4025
- Acronym
- TIME
- Status last verified
- Oct 2018
- First submitted
- 4 Jun 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Incentive and Mobilization During COPD Exacerbation
- ClinicalTrials.gov ID
- NCT01871025
- Acronym / sponsor ID
- TIME / 2012/4025
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 Jun 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.
To study the effects of early exercise training in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both groups, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.
Detailed description
Prospective randomized study in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both group, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital and home exercise training | Experimental | Other: Hospital and home exercise trainingUsual care plus hospital exercise training (aerobic and strength) followed by exercise training at home until 30 days to discharge. |
| Usual care | Other | Other: Usual careUsual care in COPD |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients for COPD exacerbation
Key exclusion criteria (4 listed)
- Hospitalization within the previous 14 days,
- current participation in rehabilitation program,
- locomotor or neurological condition or disability limiting the ability to perform exercise,
- lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.
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 |
|---|---|---|
| Hospital and home exercise trainingHospital exercise training (aerobic and strength) followed by exercise training | Other | Hospital and home exercise training |
| Usual careAlso: Usual recommendationsUsual care includes respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations, but not exercise training | Other | Usual care |
Primary outcome
Daily physical activity
Time frame: 1 month
Increase 10% moderate and/or vigorous daily physical activities after discharge
3 secondary outcomes
Tolerance to exercise
Time frame: 1 month
COPD Assessment Test (CAT)
Time frame: 1 month
Physical activity
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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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.
Diego Rodriguez, MD principal investigator
Parc de Salut Mar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital and home exercise training in people with Chronic Obstructive Pulmonary Disease, run by Parc de Salut Mar at 2 sites 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Daily physical activity (time frame: 1 month). 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 11 Oct 2018.