Chronic Obstructive Pulmonary DiseaseNCT03084874
Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Hospitalization
A study testing Physical activity and sedentary behavior coaching program in people with Chronic Obstructive Pulmonary Disease and Physical Activity, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Patients with COPD are more inactive and more sedentary than subjects of the same age and patients with other chronic diseases. This inactivity and sedentary behavior is accentuated after hospitalizations due to a COPD exacerbation, and it increases the risk for future hospitalizations and mortality. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Physical Activity, Sedentary Lifestyle
- What is being tested?
- Physical activity and sedentary behavior coaching program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2017to Dec 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of COPD according to spirometric criteria (post-bronchodilator FEV1 / FVC less than 70%)
- Smoking exposure> 10 paq/year.
- Age greater than 40 years.
- Hospitalization due to a COPD exacerbation
- Written informed consent.
Who cannot join
- Patients needing the care of an Intensive Care Unit.
- Patients who have been hospitalized more than once for a COPD exacerbation in the previous 12 months (at least 3 months from last discharge).
- Patients with continuous oxygen therapy who do not have a portable source before admission.
- Patients with severe hypoxemia at rest (SpO2 <85% at rest) at discharge
- Mental incapacity, severe comorbidity, general fragility or advanced age that could substantially difficult patient's participation in the study.
- Patients who need mechanical aids for walking.
- Patients participating in a pulmonary rehabilitation program.
- Difficulty understanding Spanish / Catalan.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Hospital Vall d'Hebron
Barcelona
Maria A Ramon, PT, PhD, maramon@vhebron.net
Esther Rodríguez, MD, PhD, estherod@vhebron.net
About this study
Official title: Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Exacerbation That Require Hospitalization
Patients with COPD are more inactive and more sedentary than subjects of the same age and patients with other chronic diseases. This inactivity and sedentary behavior is accentuated after hospitalizations due to a COPD exacerbation, and it increases the risk for future hospitalizations and mortality. Therefore, there is a need for intervention to promote physical activity and to reduce sedentary behavior after these events. The present study aims to evaluate the efficacy of a coaching program to promote physical activity and reduce sedentary behavior in patients with COPD who have suffered a hospitalization due to a COPD exacerbation. Sixty-six COPD patients admitted to the hospital will be recruited during 18 months. Physical activity, sedentary behaviors, as well as other clinical and functional parameters will be evaluated after hospital discharge. Patients will be then randomized to an intervention and control group (1:1). The intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process). The control group will receive the usual care during follow-up. Physical activity, sedentary behaviors, as well as the clinical and functional variables will be evaluated again at 12 weeks in both patients' groups.
- Being tested
- Physical activity and sedentary behavior coaching program
- Keywords
- COPD, Physical Activity, Sedentary behaviour, Hospitalization
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and sedentary behavior coaching programBehavioural
The intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the intervention group will receive an individualized coaching program to increase physical activity and reduce sedentary behavior during 12 weeks Receives: Behavioral: Physical activity and sedentary behavior coaching program |
| Control group | No intervention | Patients in the control group will receive the standard care for patients with COPD during 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in steps per day
Steps per day will be objectively measured with an accelerometer
Measured: Baseline and 12 weeks
Change in the number of active periods per day
Number of periods spent standing, walking or shuffling objectively measured with an accelerometer
Measured: Baseline and 12 weeks
Change in time spend in light and moderate physical activity
Time spend in light and moderate physical activity (1.5-3 and 3-6 METS) objectively measured with an accelerometer
Measured: Baseline and 12 weeks
Change in time spend in sedentary behavior
Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer
Measured: Baseline and 12 weeks
Breaks in sedentary behaviour
Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Change in exercise capacity
Distance walked in the 6-minute walk test
Measured: Baseline and 12 weeks
Change in muscle force
Quadriceps muscle force tested with a hand-held dynamometer
Measured: Baseline and 12 weeks
Change in patient's quality of life
patient's quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) anbd the COPD assesment test (CAT)
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (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.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084874
- Sponsor's protocol ID
- PR(AG)390/2015
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Exacerbation That Require Hospitalization
- ClinicalTrials.gov ID
- NCT03084874
- Acronym / sponsor ID
- PR(AG)390/2015
- Keywords
- COPD, Physical Activity, Sedentary behaviour, Hospitalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery
- Study start
- Mar 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Mar 2017 (actual)
- 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.
Patients with COPD are more inactive and more sedentary than subjects of the same age and patients with other chronic diseases. This inactivity and sedentary behavior is accentuated after hospitalizations due to a COPD exacerbation, and it increases the risk for future hospitalizations and mortality. Therefore, there is a need for intervention to promote physical activity and to reduce sedentary behavior after these events. The present study aims to evaluate the efficacy of a coaching program to promote physical activity and reduce sedentary behavior in patients with COPD who have suffered a hospitalization due to a COPD exacerbation. Sixty-six COPD patients admitted to the hospital will be recruited during 18 months. Physical activity, sedentary behaviors, as well as other clinical and functional parameters will be evaluated after hospital discharge. Patients will be then randomized to an intervention and control group (1:1). The intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process). The control group will receive the usual care during follow-up. Physical activity, sedentary behaviors, as well as the clinical and functional variables will be evaluated again at 12 weeks in both patients' groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical activity and sedentary behavior coaching programPatients in the intervention group will receive an individualized coaching program to increase physical activity and reduce sedentary behavior during 12 weeks |
| Control group | No intervention | –Patients in the control group will receive the standard care for patients with COPD during 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous diagnosis of COPD according to spirometric criteria (post-bronchodilator FEV1 / FVC less than 70%)
- Smoking exposure> 10 paq/year.
- Age greater than 40 years.
- Hospitalization due to a COPD exacerbation
- Written informed consent.
Key exclusion criteria (8 listed)
- Patients needing the care of an Intensive Care Unit.
- Patients who have been hospitalized more than once for a COPD exacerbation in the previous 12 months (at least 3 months from last discharge).
- Patients with continuous oxygen therapy who do not have a portable source before admission.
- Patients with severe hypoxemia at rest (SpO2 <85% at rest) at discharge
- Mental incapacity, severe comorbidity, general fragility or advanced age that could substantially difficult patient's participation in the study.
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 |
|---|---|---|
| Physical activity and sedentary behavior coaching programThe intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process). | Behavioural | Intervention group |
Primary outcome
Change in steps per day
Time frame: Baseline and 12 weeks
Steps per day will be objectively measured with an accelerometer
Change in the number of active periods per day
Time frame: Baseline and 12 weeks
Number of periods spent standing, walking or shuffling objectively measured with an accelerometer
Change in time spend in light and moderate physical activity
Time frame: Baseline and 12 weeks
Time spend in light and moderate physical activity (1.5-3 and 3-6 METS) objectively measured with an accelerometer
Change in time spend in sedentary behavior
Time frame: Baseline and 12 weeks
Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer
Breaks in sedentary behaviour
Time frame: Baseline and 12 weeks
Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer
3 secondary outcomes
Change in exercise capacity
Time frame: Baseline and 12 weeks
Change in muscle force
Time frame: Baseline and 12 weeks
Change in patient's quality of life
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and sedentary behavior coaching program in people with Chronic Obstructive Pulmonary Disease and Physical Activity, run by Hospital Universitari Vall d'Hebron Research Institute 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 5 inclusion and 8 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 21 Mar 2017. 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?
Contact Maria A Ramon, PT, PhD (0034932746107, maramon@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in steps per day (time frame: Baseline and 12 weeks). The study lists 5 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 21 Mar 2017.