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Chronic Obstructive Pulmonary Disease (COPD)NCT06882863

Reducing Sedentary Behavior in Patients with Severe COPD: a Feasibility Study on Nurse-Led Motivational Intervention

A study testing Motivational interviewing in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zealand University Hospital at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This feasibility study aims to assess the practicality and acceptability of a nurse-led motivational interview intervention designed to reduce sedentary behavior in patients with severe Chronic Obstructive Pulmonary Disease (COPD). Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Motivational interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteDenmark
Study dates
19 Mar 2025to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Diagnosed with severe COPD confirmed by a healthcare provider.
  • Aged 65 years or older at the time of enrollment.
  • Self-reported sedentary behavior of at least 5 hours per day.
  • Able to provide informed consent and participate in a home-based interview.
  • Not currently enrolled in a structured pulmonary rehabilitation program.

Who cannot join

  • Severe cognitive impairment that prevents meaningful participation in the motivational interview.
  • Physical disability that completely prevents movement and makes physical activity recommendations irrelevant.
  • Severe comorbidities with a life expectancy of less than six months.
  • Inability to understand or communicate in Danish.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site
  • Zealand University Hospital

    Roskilde, 4000

Other trials in Denmark

About this study

Official title: Reducing Sedentary Behavior in Patients with Severe COPD: a Nurse-Led Motivational Intervention

This feasibility study aims to assess the practicality and acceptability of a nurse-led motivational interview intervention designed to reduce sedentary behavior in patients with severe Chronic Obstructive Pulmonary Disease (COPD). The study will evaluate the recruitment process, patient adherence, and the usability of accelerometers for objectively measuring sedentary time.

A total of 10-12 patients with severe COPD will be recruited and receive individual motivational interviews conducted by trained nurses in their homes. The intervention will be based on motivational interviewing (MI) and Cognitive Behavioral Therapy (CBT) principles, focusing on helping patients identify barriers and set realistic goals to increase physical activity.

The study will determine whether patients tolerate wearing accelerometers for seven days at different time points and whether the intervention is acceptable to both patients and nurses. Insights gained from this feasibility study will guide refinements to the intervention before launching a randomized controlled trial (RCT) to test its effectiveness on a larger scale.

Read the detailed description

This feasibility study is designed to assess whether a nurse-led motivational interview intervention can be effectively implemented to reduce sedentary behavior in patients with severe Chronic Obstructive Pulmonary Disease (COPD). Severe COPD is associated with breathlessness and functional limitations, which often lead to prolonged sedentary time, increasing the risk of disease progression and reduced quality of life. Although pulmonary rehabilitation programs exist, many patients struggle with participation due to physical discomfort, lack of motivation, or fear of exacerbating their symptoms. This study aims to evaluate whether an intervention focusing on behavioral change and motivation can help patients engage in small but meaningful reductions in sedentary time.

The feasibility study will recruit 10 patients with severe COPD from pulmonary outpatient clinics. Each participant will receive two to three motivational interviews conducted by a trained nurse in their home over a period of three months. The intervention is based on motivational interviewing (MI) and Cognitive Behavioral Therapy (CBT) principles, both of which have shown effectiveness in supporting behavior change. During these sessions, the nurse will help the patient identify their current level of sedentary behavior, explore their personal motivations for change, and work together to develop achievable, realistic strategies to increase physical activity in daily life. The intervention will focus on small, individualized goals, such as standing up during television commercials, incorporating brief walks, or engaging in light household activities, with the aim of making these changes sustainable.

A critical aspect of the study is assessing whether patients are willing and able to wear accelerometers to measure their sedentary time objectively. Each participant will wear an accelerometer for seven consecutive days before the intervention, allowing researchers to evaluate whether the device is tolerated and whether it provides reliable data on activity levels. In addition to the accelerometer data, participants will provide feedback on their experience with the intervention, including how easy or difficult it was to implement suggested changes, whether they found the motivational interviews helpful, and whether they encountered any barriers. Nurses delivering the intervention will also provide feedback on the practicality of the sessions, the level of patient engagement, and any modifications that may be needed to improve the intervention before scaling up to a larger trial.

The study will also examine how well patients adhere to the intervention, tracking how many complete all scheduled sessions and whether they report making changes to their daily activity patterns. By evaluating recruitment success, adherence rates, patient satisfaction, and the usability of accelerometer-based measurements, the study will identify whether the intervention is feasible and acceptable for both patients and healthcare providers. If challenges arise, adjustments will be made to refine the recruitment process, session structure, or measurement methods before proceeding to a full randomized controlled trial (RCT).

The findings from this feasibility study will be used to optimize the intervention and study design, ensuring that a future large-scale trial can be conducted smoothly and effectively. If successful, this nurse-led motivational interview approach could become a valuable component of COPD care, helping patients make meaningful, sustainable reductions in sedentary behavior, improving their overall health and well-being.

Being tested
Motivational interviewing
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.

  • Motivational interviewingBehavioural

    This intervention consists of a single nurse-led motivational interview aimed at reducing sedentary behavior in patients with severe COPD. The session, conducted in the patient's home, lasts approximately 60 minutes and focuses on identifying personal barriers, exploring motivation, and setting small, realistic goals to reduce sedentary time.

    Unlike traditional pulmonary rehabilitation, this intervention does not involve structured exercise but instead uses motivational interviewing (MI) techniques to encourage gradual behavior change in daily routines. Before the intervention, patients wear an accelerometer for seven days to objectively measure baseline sedentary time. The study assesses feasibility, patient engagement, and adherence to determine whether the approach is suitable for a larger randomized controlled trial (RCT).

Study groups in NCT06882863
Study groupRoleWhat they receive
FeasibilityExperimentalThis feasibility study involves a single-arm intervention where patients with severe COPD receive nurse-led motivational interviews to reduce sedentary behavior. Participants recieve one 60 minute intervention, focusing on identifying barriers, setting small activity goals, and building motivation using motivational interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques. Participants wear accelerometers for seven days before the intervention to measure changes in sedentary time. The study assesses recruitment feasibility, adherence, and patient acceptability, informing refinements before a future randomized controlled trial (RCT).
Receives: Behavioral: Motivational interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and acceptability of the intervention

    Measured by the number of participants who successfully complete the intervention.

    Measured: From enrollment to one week post-intervention

Secondary outcomes (3)
  1. questionnaire

    Measured by the number of participants who successfully complete the provided questionnaire SF-12

    Measured: From enrollment to one week post-intervention

  2. questionnaire

    Measured by the number of participants who successfully complete the provided questionnaire CRQ

    Measured: From enrollment to one week post-intervention

  3. questionnaire

    Measured by the number of participants who successfully complete the provided questionnaire HADS.

    Measured: From enrollment to one week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start19 Mar 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06882863
Sponsor's protocol ID
SJ-1089
Status last verified
Feb 2025
First submitted
11 Mar 2025
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zealand University Hospital at 1 site in Denmark.

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 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: enrolling by invitation, as of the sponsor's last update on 25 Mar 2025. 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 Denmark. 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?

This study is still under way. Results are not available in the source record yet.

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?

Feasibility and acceptability of the intervention (time frame: From enrollment to one week post-intervention). 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 25 Mar 2025.

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Clinical Trial NCT06882863 | AzTrials