RehabilitationCOPDEXlifelongNCT07870655
Long-term Effects and Maintenance of Exercise Habits in Individuals With COPD
An observational study of Rehabilitation and COPD (Chronic Obstructive Pulmonary Disease), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study aims to evaluate exercise habits and relevant health outcomes at 6 months and again 12 to 18 months after participation in the COPDEX trial (NCT06551441). Specifically, we will investigate the extent to which participants maintain regular exercise in the absence of supervision, how long-term exercise… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rehabilitation, COPD (Chronic Obstructive Pulmonary Disease)
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2026to 30 May 2028
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals in the age >=40 and <80 years with COPD previously participating in the COPDEX trial
Who may be able to join
- Participated in the clinical trial The COPDEX study. Exclusion criteria
Who cannot join
- There are no exclusion criteria for participation in the follow-up study. Prior to the study visit, participants will undergo a medical interview and examination. Participants with contraindications to specific study procedures will remain enrolled in the study but will not undergo the relevant assessments.
- Contraindications to cardiopulmonary exercise are:
- Symptoms suggestive of unstable ischaemic heart disease
- Acute myocardial infarction within the preceding 3 months
- Uncontrolled cardiac arrhythmias
- Decompensated heart failure
Show all 22Show fewer
- Severe symptomatic valvular heart disease
- Uncontrolled arterial hypertension (>180/110 mmHg at rest)
- Acute pulmonary embolism
- Acute respiratory infection or COPD exacerbation within the preceding 2 weeks
- Severe musculoskeletal, neurological, or cognitive conditions precluding safe test performance
- Any other condition judged by the study physician to make participation unsafe
- Lung function testing will be performed according to current ATS/ERS recommendations. Contraindications to spirometry and other forced expiratory manoeuvres are:
- Acute myocardial infarction within the preceding month
- Unstable angina
- Recent thoracic, abdominal, cerebral, or ophthalmic surgery where forced expiratory manoeuvres may compromise recovery
- Current pneumothorax
- Active haemoptysis of unknown origin
- Thoracic, abdominal, or cerebral aneurysm judged to be at risk from increased intrathoracic pressure
- Acute respiratory infection judged by the study physician to make testing unsafe.
- Any other condition judged by the study physician to make testing unsafe
- Participants unable to perform pulmonary function testing or spirometry may still participate in all other assessments considered safe and feasible.
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
Centre for Physical Activity Research, Copenhagen University Hospital
Copenhagen
About this study
Official title: Long-term Effects and Maintenance of Exercise Habits in Individuals With COPD: A Follow-up Study of a Clinical Exercise Trial
The study aims to evaluate exercise habits and relevant health outcomes at 6 months and again 12 to 18 months after participation in the COPDEX trial (NCT06551441).
Specifically, we will investigate the extent to which participants maintain regular exercise in the absence of supervision, how long-term exercise behaviour is associated with quality of life and physical capacity, and identify key motivational facilitators and barriers associated with sustained exercise participation
Read more
Primary objective is to investigate health-related quality of life in individuals with COPD at 6 months and again 12 to 18 months after participation in the COPDEX trial.
Secondary objectives is to investigate exercise habits, physical activity levels, cardiorespiratory fitness, lung function, functional exercise capacity, and body composition in individuals with COPD 6 months and again 12 to 18 months after participation in the COPDEX trial; to explore differences in long-term outcomes according to original allocation in the COPDEX trial; to identify motivational facilitators and barriers associated with the initiation and maintenance of regular exercise following participation in the COPDEX trial.
At completion of the randomised controlled exercise trial COPDEX (protocol no. H-24021751), which examined the effects of 6 months of high-intensity interval training (HIIT; three sessions per week) compared with usual activity, all participants were encouraged to either continue or initiate regular exercise. All previous participants will be invited to participate in the present follow-up study, irrespective of their original allocation (HIIT group or usual activity group).
- Keywords
- follow-up
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Prior completed COPDEX participants | Inclusion criteria: Participated in the clinical trial The COPDEX study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
COPD Assessment Test (CAT) score (0-40). Zero means the disease has a no impact on health and 40 means the disease has a worse impact on health.
Measured: Day 1
Secondary outcomes (5)
VO2peak
Absolut (mL/min) V̇O2peak. Measured at 6 and 12 to 18 months
Measured: 1 day
VO2peak
Relative (mL/kg/min) V̇O2peak. Measured at 6 and 12 to 18 months
Measured: Day 1
Daily step-count
Measurement of daily step count using AX3 monitoring at 6 and 12-18 months
Measured: Day 1
Ventilatory threshold (%)
Ventilatory threshold (ml/min) (%) measured at 6 and 12 to 18 months
Measured: Day 1
Ventilatory reserve (%)
Determination of ventilatory reserve (%). Measured at 6 and 12 to 18 months
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronan Berg, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870655
- Sponsor's protocol ID
- H-26054355
- Acronym
- COPDEXlifelong
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects and Maintenance of Exercise Habits in Individuals With COPD: A Follow-up Study of a Clinical Exercise Trial
- ClinicalTrials.gov ID
- NCT07870655
- Acronym / sponsor ID
- COPDEXlifelong / H-26054355
- Keywords
- follow-up
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 13 Oct 2026 (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.
The study aims to evaluate exercise habits and relevant health outcomes at 6 months and again 12 to 18 months after participation in the COPDEX trial (NCT06551441).
Specifically, we will investigate the extent to which participants maintain regular exercise in the absence of supervision, how long-term exercise behaviour is associated with quality of life and physical capacity, and identify key motivational facilitators and barriers associated with sustained exercise participation
Primary objective is to investigate health-related quality of life in individuals with COPD at 6 months and again 12 to 18 months after participation in the COPDEX trial.
Secondary objectives is to investigate exercise habits, physical activity levels, cardiorespiratory fitness, lung function, functional exercise capacity, and body composition in individuals with COPD 6 months and again 12 to 18 months after participation in the COPDEX trial; to explore differences in long-term outcomes according to original allocation in the COPDEX trial; to identify motivational facilitators and barriers associated with the initiation and maintenance of regular exercise following participation in the COPDEX trial.
At completion of the randomised controlled exercise trial COPDEX (protocol no. H-24021751), which examined the effects of 6 months of high-intensity interval training (HIIT; three sessions per week) compared with usual activity, all participants were encouraged to either continue or initiate regular exercise. All previous participants will be invited to participate in the present follow-up study, irrespective of their original allocation (HIIT group or usual activity group).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prior completed COPDEX participants | – | –Inclusion criteria: Participated in the clinical trial The COPDEX study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals in the age >=40 and <80 years with COPD previously participating in the COPDEX trial
Key inclusion criteria (1 listed)
- Participated in the clinical trial The COPDEX study. Exclusion criteria
Key exclusion criteria (22 listed)
- There are no exclusion criteria for participation in the follow-up study. Prior to the study visit, participants will undergo a medical interview and examination. Participants with contraindications to specific study procedures will remain enrolled in the study but will not undergo the relevant assessments.
- Symptoms suggestive of unstable ischaemic heart disease
- Acute myocardial infarction within the preceding 3 months
- Uncontrolled cardiac arrhythmias
- Decompensated heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life
Time frame: Day 1
COPD Assessment Test (CAT) score (0-40). Zero means the disease has a no impact on health and 40 means the disease has a worse impact on health.
5 secondary outcomes
VO2peak
Time frame: 1 day
VO2peak
Time frame: Day 1
Daily step-count
Time frame: Day 1
Ventilatory threshold (%)
Time frame: Day 1
Ventilatory reserve (%)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation and COPD (Chronic Obstructive Pulmonary Disease), run by Copenhagen University Hospital, Rigshospitalet 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 1 inclusion and 22 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 13 Oct 2026. 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?
Health-related quality of life (time frame: Day 1). 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 13 Oct 2026.