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Chronic Obstructive Pulmonary DiseaseCOPDEX0NCT05552833

Pulmonary Adaptive Responses to HIIT in COPD

A study testing High intensity interval training in people with Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise can improve quality of life in these patients, but the health care system lack the underlying mechanism of exercise-induced… Read more about this study

Who is it for?
Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
High intensity interval training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesDenmark
Study dates
5 Sep 2022to 1 Aug 2024
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 45 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women
  • 45-80 years
  • COPD (GOLD stage I to III)
  • Forced expiratory volume in 1 sec (FEV1)/forced vital capacity ratio (FVC) < 0.8, FEV1 < 90% of predicted value
  • Modified Medical Research Council score (mMRC 0 - 3)
  • Resting arterial oxygenation > 90%
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  • Do not fulfil the physical activity recommendations by the Danish Health Authority
  • Men and women
  • 45-80 years
  • Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
  • Same sex, age (± 3 years) and BMI (± 10%)
  • Do not fulfil the physical activity recommendations by the Danish Health Authority (19)
  • BMI 18-35

Who cannot join

  • Symptoms of ischaemic heart disease
  • Known heart failure
  • Previous severe or current COVID-19
  • Unable to complete or understand HIIT training
  • Claudication
  • Symptoms of disease within 2 weeks prior to the study
Show all 23Show fewer
  • Participation in pulmonary rehabilitation within 6 months
  • Known malignant disease
  • Pregnancy
  • Unstable cardiac arrhythmic disease
  • Renal or liver dysfunction
  • COPD
  • Asthma
  • Known ischaemic heart disease
  • Known heart failure
  • Previous severe or current COVID-19
  • Unable to complete or understand HIIT training
  • Symptoms of disease within 2 weeks prior to the study
  • Known malignant disease
  • Claudication
  • Pregnancy
  • Unstable cardiac arrhythmic disease
  • Renal or liver dysfunction

Trial locations and contacts

2 sites in 1 country.

Ronan Martin Griffin Berg, MD contact

(+45) 3545 7641

ronan.martin.griffin.berg@regionh.dk

Denmark2 sites, 2 recruiting
  • Centre for Physical Activity Research (CFAS)

    Copenhagen, 2100

    Jacob Peter Hartmann, MD, 40924285, jacob.peter.okholm.hartmann.01@regionh.dk

    Recruiting
  • Rigshospitalet

    Copenhagen, 2100

    Ronan Berg, MD, +45-35451825, ronan@sund.ku.dk

    Regitse Christensen, MD, +45-35451825, Regitse.Hoejgaard.Christensen@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise can improve quality of life in these patients, but the health care system lack the underlying mechanism of exercise-induced improvement in COPD and it is widely thought not to have any effect on lung function. The aim of the present study is to investigate to which extent lung tissue mass and rest-to-exercise diffusion capacity changes differ in COPD patients compared to the healthy state. In order to design prospective clinical trials on the putative impact of high-intensity interval training (HIIT) investigating these parameters, and a secondary aim is to assess the feasibility of such a study in terms of patient inclusion, adherence and methodology.

Read the detailed description

Patients with Chronic obstructive pulmonary disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise is considered the most effective non-pharmacological intervention for improving quality of life in these patients. However, its use is halted by the lack of understanding of the mechanism of exercise-induced improvement in COPD, and is widely thought not to have any effect on lung function in the clinical setting. Exercise is thus mainly considered a way to alleviate symptoms, primarily by improving skeletal muscle function, but without the potential to reverse the disease. Therefore, relatively short and low-intensity exercise interventions are typically prescribed and are often not pursued in patients with the greatest symptom burden.

The reasoning for not prescribing exercise more widely in COPD is based on two assumptions: 1) new tissue cannot be formed in the adult lung, and 2) no consistent exercise training-induced changes in lung function have previously been documented.

However, de novo tissue formation has repeatedly been demonstrated in the adult lung, both in animals and humans, primarily in response to prolonged hypoxia and pneumonectomy. It has recently been reported that interval-based training counteracts the progressive loss of lung tissue in animal models of experimental COPD. The most likely stimulus is the mechanical strain, and if any measurable changes are to be induced by training, a high-intensity interval training (HIIT) scheme is preferable to be initiated in pulmonary rehabilitation.

On this basis, this study aim to conduct a prospective randomised trial, in which the impact of HIIT on lung weight (assessed by CT), rest-to-exercise diffusion capacity, 3-dimensional distribution of pulmonary perfusion measured by single photon emission computed tomography (SPECT)-low dose CT are addressed. Indeed, the latter is an especially useful clinical tool for the pathophysiological classification of COPD patients, and rest-to-exercise SPECT has the potential as a diagnostic tool that 'pinpoints' the exact cause of dyspnoea in the individual COPD patient, but has not yet been validated for this purpose. While all the methods are established, there is a need for more information regarding COPD-associated changes in lung tissue mass ('lung weight') and rest-to-exercise pulmonary diffusion changes compared to the healthy state. An assessment of the feasibility of an extended HIIT-trial using these methods in COPD patients as well as estimates of the in-study changes in the resultant physiological estimates (for the purpose of sample size estimations) is warranted.

Being tested
High intensity interval training
Keywords
High intensity interval training (HIIT), Lung growth, Diffusion capacity, Blood flow, Lung tissue mass, Oxygen extraction
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.

  • High intensity interval trainingOther

    Participants will undergo 12 weeks of supervised HIIT training (3 times per week). The HIIT protocol will consist of 4x4 min.

Study groups in NCT05552833
Study groupRoleWhat they receive
COPD patientsExperimentalThis arm will consist of only COPD patients.
Receives: Other: High intensity interval training
Healthy controlsExperimentalThis arm will consist of age and BMI matched healthy controls.
Receives: Other: High intensity interval training

What is being measured

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

  1. Lung tissue mass

    Change in lung weight in COPD patients compared to matched controls using CT-scans.

    Measured: CT-scans at baseline and at 12 week follow up.

  2. Rest-to-exercise diffusion capacity

    Change in rest-to-exercise pulmonary diffusion capacity between COPD patients and matched healthy controls measured by DLNO/CO.

    Measured: DLNO/CO measured at baseline and at 12 week follow up.

Secondary outcomes (2)
  1. Rest-to-exercise pulmonary perfusion ratio change

    Rest-to-exercise pulmonary perfusion ratio change in COPD patients compared to matched controls measured by single photon emission computed tomography (SPECT).

    Measured: At baseline and at 12 week follow up

  2. Rest-to-exercise leg blood flow change in COPD

    Rest-to-exercise leg blood flow change in COPD patients compared to matched controls measured by ultrasound doppler in a single leg knee extensor model.

    Measured: At baseline and at 12 week follow up

Timeline

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

  1. First posted23 Sep 2022
  2. Study start5 Sep 2022
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2024 (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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
12 COPD will undergo the intervention in one arm and 12 healthy, age and BMI matched individuals will undergo the same intervention.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552833
Sponsor's protocol ID
COPDEX0
Acronym
COPDEX0
Status last verified
Oct 2022
First submitted
13 Sep 2022
Last updated
17 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Can be retrieved upon request from primary investigator.

Questions about this trial

What is this clinical trial studying?

A study testing High intensity interval training in people with Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 13 inclusion and 23 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 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ronan Martin Griffin Berg, MD ((+45) 3545 7641, ronan.martin.griffin.berg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung tissue mass (time frame: CT-scans at baseline and at 12 week follow up.). The study lists 2 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 17 Oct 2022.

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