Pulmonary Disease, Chronic ObstructivePhase 2COPDNCT01539434
Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Behavioural intervention in people with Pulmonary Disease, Chronic Obstructive, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate to what extent patients with COPD, who have participated in physical training for 12 weeks, can maintain their physical activity behaviour and physical capacity on a long-term basis if they get a behavioural medicine intervention. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Behavioural intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Dec 2020
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD at Uppsala and Umeå university hospitals, who have participated in physical training at the hospital for 12 weeks.
- Diagnose of COPD
Who cannot join
- Understand the Swedish language
- Be able to be physically active
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, 75124
Margareta Emtner, PhD, +46184714761, margareta.emtner@neuro.uu.se
Christer Janson, Professor, +46704250441, christer.janson@medsci.uu.se
About this study
Official title: Behavioral Medicine Intervention to Maintain Physical Capacity and Level of Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to investigate to what extent patients with COPD, who have participated in physical training for 12 weeks, can maintain their physical activity behaviour and physical capacity on a long-term basis if they get a behavioural medicine intervention.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease and the number of patients is increasing. Persons with COPD have a low physical capacity and a low physical activity level. The risk of premature morbidity and mortality is high especially in persons with a low level of physical capacity and activity. Rehabilitation including physical training is recommended and results in decreased morbidity and mortality and increased physical capacity and quality of life. Unfortunately improvements decrease if patients do not maintain their physical activity level.
To change physical activity behaviour in is challenging. Different methods as Social Cognitive Theory, SCT and the Transtheoretical model, TTM have been suggested as theoretical framework. According to SCT, to improve physical activity behaviour you should use goal-setting, outcome expectancy, self-efficacy, and self-monitoring.
To use motivational interviewing (MI) improves the success of a behaviour change.
Patients will be randomized after the 12-week training period, tested, and thereafter both the intervention group and the control group will get information about the importance of physical activity and the recommendations.
Thereafter patients in the intervention group will receive weekly telephone calls for the first month, telephone calls every second week for the following two months and thereafter monthly telephone calls for the following three months. The telephone calls will be in accordance with MI and discuss goal-setting, out-come expectancy, and self-monitoring.
Patients will be tested after 6,12,and 24 months.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Behavioural intervention, Usual care group
- Keywords
- COPD, Behavioral intervention, Physical capacity, Physical activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural interventionBehavioural
Also called Physical capacity, Physical activity
Patients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls.
Usual care groupBehavioural
Also called Physical capacity, Physical activity
Patients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural intervention | Experimental | Patients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls. Receives: Behavioral: Behavioural intervention |
| Usual care group | Active comparator | Patients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. Receives: Behavioral: Usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walking distance
Change in six-minute walking distance
Measured: Change from baseline and 6 months and up to 24 months
Secondary outcomes (5)
Physical activity level
Number of steps, energy expenditure, time in different positions
Measured: Change from baseline and 6 months and up to 24 months
Short Form 36
Measures health related quality of life
Measured: Change from baseline and 6 months and up to 24 months
Chronic Respiratory Disease Questionnaire
Measures health related quality of life
Measured: Change from baseline and 6 months and up to 24 months
Hospital anxiety and depression scale
Measures anxiety and depression
Measured: Change from baseline and 6 months and up to 24 months
Grippit
Hand muscle strength
Measured: Change from baseline and 6 months and up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Sponsor
- Investigators
- Margareta Emtner, PhD, Principal investigator, Uppsala UniversityKarin Wadell, PhD, Study chair, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539434
- Sponsor's protocol ID
- UOU-2012-MEKW
- Acronym
- COPD
- Status last verified
- May 2017
- First submitted
- 8 Feb 2012
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Medicine Intervention to Maintain Physical Capacity and Level of Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01539434
- Acronym / sponsor ID
- COPD / UOU-2012-MEKW
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Behavioral intervention, Physical capacity, Physical activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- Sep 2010 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Feb 2012 (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.
The purpose of this study is to investigate to what extent patients with COPD, who have participated in physical training for 12 weeks, can maintain their physical activity behaviour and physical capacity on a long-term basis if they get a behavioural medicine intervention.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease and the number of patients is increasing. Persons with COPD have a low physical capacity and a low physical activity level. The risk of premature morbidity and mortality is high especially in persons with a low level of physical capacity and activity. Rehabilitation including physical training is recommended and results in decreased morbidity and mortality and increased physical capacity and quality of life. Unfortunately improvements decrease if patients do not maintain their physical activity level.
To change physical activity behaviour in is challenging. Different methods as Social Cognitive Theory, SCT and the Transtheoretical model, TTM have been suggested as theoretical framework. According to SCT, to improve physical activity behaviour you should use goal-setting, outcome expectancy, self-efficacy, and self-monitoring.
To use motivational interviewing (MI) improves the success of a behaviour change.
Patients will be randomized after the 12-week training period, tested, and thereafter both the intervention group and the control group will get information about the importance of physical activity and the recommendations.
Thereafter patients in the intervention group will receive weekly telephone calls for the first month, telephone calls every second week for the following two months and thereafter monthly telephone calls for the following three months. The telephone calls will be in accordance with MI and discuss goal-setting, out-come expectancy, and self-monitoring.
Patients will be tested after 6,12,and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioural intervention | Experimental | Behavioral: Behavioural interventionPatients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls. |
| Usual care group | Active comparator | Behavioral: Usual care groupPatients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with COPD at Uppsala and Umeå university hospitals, who have participated in physical training at the hospital for 12 weeks.
- Diagnose of COPD
Key exclusion criteria (2 listed)
- Understand the Swedish language
- Be able to be physically active
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 |
|---|---|---|
| Behavioural interventionAlso: Physical capacity, Physical activityPatients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls. | Behavioural | Behavioural intervention |
| Usual care groupAlso: Physical capacity, Physical activityPatients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. | Behavioural | Usual care group |
Primary outcome
Six-minute walking distance
Time frame: Change from baseline and 6 months and up to 24 months
Change in six-minute walking distance
5 secondary outcomes
Physical activity level
Time frame: Change from baseline and 6 months and up to 24 months
Short Form 36
Time frame: Change from baseline and 6 months and up to 24 months
Chronic Respiratory Disease Questionnaire
Time frame: Change from baseline and 6 months and up to 24 months
Hospital anxiety and depression scale
Time frame: Change from baseline and 6 months and up to 24 months
Grippit
Time frame: Change from baseline and 6 months and up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Related trials for Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
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.
Margareta Emtner, PhD principal investigator
Uppsala University
Karin Wadell, PhD study chair
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavioural intervention in people with Pulmonary Disease, Chronic Obstructive, run by Uppsala University at 1 site in Sweden.
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 2 inclusion and 2 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 19 May 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Margareta Emtner, PhD (+46184714761, margareta.emtner@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walking distance (time frame: Change from baseline and 6 months and up to 24 months). 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 19 May 2017.