ClinicalTrials.gg
Sign In
Enrolling by invitationNCT07870655COPDEXlifelongUpdated Oct 13, 2026

Long-term Effects and Maintenance of Exercise Habits in Individuals With COPD

An observational study in Rehabilitation and COPD (Chronic Obstructive Pulmonary Disease), sponsored by Copenhagen University Hospital, Rigshospitalet. Enrolling by invitation at 1 site in Denmark. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
40 Years to 80 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Rehabilitation
  • COPD (Chronic Obstructive Pulmonary Disease)

Keywords

  • follow-up
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 66 is below the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals in the age >=40 and \<80 years with COPD previously participating in the COPDEX trial

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participated in the clinical trial The COPDEX study. Exclusion criteria

Exclusion criteria

Exclusion Criteria:

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
  • 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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prior completed COPDEX participants

    Inclusion criteria: Participated in the clinical trial The COPDEX study.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

Secondary outcomes

  1. VO2peak

    Absolut (mL/min) V̇O2peak. Measured at 6 and 12 to 18 months

    Time frame: 1 day

  2. VO2peak

    Relative (mL/kg/min) V̇O2peak. Measured at 6 and 12 to 18 months

    Time frame: Day 1

  3. Daily step-count

    Measurement of daily step count using AX3 monitoring at 6 and 12-18 months

    Time frame: Day 1

  4. Ventilatory threshold (%)

    Ventilatory threshold (ml/min) (%) measured at 6 and 12 to 18 months

    Time frame: Day 1

  5. Ventilatory reserve (%)

    Determination of ventilatory reserve (%). Measured at 6 and 12 to 18 months

    Time frame: Day 1

Other outcomes

  1. IPAQ

    IPAQ score: Expressed as MET-minutes per week. Participants are categorized as having low (\<600 MET-min/week), moderate (600-2999 MET-min/week), or high (≥3000 MET-min/week) physical activity levels

    Time frame: Day 1

  2. Airway Resistance (Rrs, R5-R20)

    Measured at 6 and 12-18 months in resistance (Rrs, R5-R20) measured by IOS)

    Time frame: Day 1

  3. Airway reactance (Xrs, X5,AX)

    Measured by IOS at 6 and 12-18 months

    Time frame: Day 1

  4. Health-related quality of life: St. George's Respiratory Questionnaire (SGRQ) 0-100

    Measured through questionnaire. Zero means the best health status and 100 means worse status.

    Time frame: Day 1

  5. 6-minute walking test

    Distance (m) walked measured at 6 and12-18 months in a 6-minute walking test

    Time frame: Day 1

  6. Hand-grip strength (kg)

    Measured at 6 and 12-18 months in hand-grip strength (kg)

    Time frame: Day 1

  7. Sit-to-stand test (n).

    Measured at 6 and 12-18 months of completed 60 seconds sit-to-stand test (n)

    Time frame: Day 1

  8. Body composition

    Measured at 6 and 12-18 months in body composition: total mass (kg)

    Time frame: Day 1

  9. Lung function

    Measured at 6 and 12 to 18 months in lung function: FEV1 (L and %pred)

    Time frame: Day 1

  10. Body composition

    Measured at 6 and 12-18 months in body composition: total fat mass (kg and %)

    Time frame: Day 1

  11. Body composition

    Measured at 6 and 12-18 months in lean body mass (kg)

    Time frame: Day 1

  12. Lung function

    Measured at 6 and 12 to 18 months in lung function: FVC (L and %pred)

    Time frame: Day 1

  13. Lung function

    Measured at 6 and 12 to 18 months in lung function: RV (L and %pred)

    Time frame: Day 1

  14. Lung function

    Measured at 6 and 12 to 18 months in lung function: TLC (L and %pred)

    Time frame: Day 1

  15. Lung function

    Measured at 6 and 12 to 18 months in lung function: single-breath diffusion capacity to carbon monoxide (mmol/(min kPa) and %pred).

    Time frame: Day 1

  16. Duration of sedentary time

    Measured by AX3 monitor at 6 and 12-18 months

    Time frame: Day 1

  17. Breaks in sedentary time

    Measured by AX3 monitor at 6 and 12-18 months

    Time frame: Day 1

  18. Time stamps on posture allocation

    Measured by AX3 monitor at 6 and 12-18 months

    Time frame: Day 1

  19. The intensity of any physical activity

    Measured by AX3 monitor at 6 and 12-18 months

    Time frame: Day 1

  20. Focus groups interviews

    To identify and understand the factors that motivates individuals with COPD to participate in, and adhere to, unsupervised exercise training, including perceived benefits, motivational factors and barrier to continue participation

    Time frame: Day 1

07

Study locations

1 site
  • Centre for Physical Activity Research, Copenhagen University Hospital
    Copenhagen, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.

Of 330 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's planned 7 months is below that.

Counting every sponsor, half of 429 studies reached it within 28 months; a quarter within 16 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
May 30, 2027
CompletionEst.
May 30, 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870655
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Ronan Berg (MD, DMSc, Professor, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
May 30, 2028 (estimated)
Last update
Oct 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pulmonary Disease, Chronic Obstructive →

Other studies from this sponsor

Copenhagen University Hospital, Rigshospitalet

Start the discussion