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COPDNCT05343949

High Intensity Interval Training and Technologies in COPD

A study testing HIIT exercise program ABC, HIIT exercise program CAB and HIIT exercise program BCA in people with COPD, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Trials in COPD have shown that HIIT leads to the same positive outcomes as constant load training but causes less breathlessness and leg discomfort during training. However, HIIT protocols in existing trials have all been different and use relatively long interval durations (30 s) and short rests. Read more about this study

Who is it for?
Ages 30 to 90 years
Conditions the study is for
COPD
What is being tested?
HIIT exercise program ABC, HIIT exercise program CAB and HIIT exercise program BCA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
8 May 2019to 25 Nov 2022
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 30 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mild, Moderate and severe* COPD forced expired volume (FEV-1) ≥30 with an FEV-1/ forced vital capacity (FVC) ratio <70%) confirmed on spirometry within 6 months of recruitment.
  • Chronic breathlessness that limits exercise capacity (mMRC ≥2).
  • Using inhaled therapy for COPD including a long-acting bronchodilator agonist (LABA and/or long acting muscarinic agonist (LAMA) with or without inhaled corticosteroids (ICS).
  • Oxygen saturations ≥90% breathing room air.
  • Willing and able to undertake study procedures.
  • Has provided informed consent. * Mild and Moderate COPD patients will be recruited from the start of the study. A review of exercise session completion rates and adverse events will be performed after 10 patients have been recruited to assess the tolerability and acceptability of the different HIIT protocols prior to beginning recruitment of people with severe COPD

Who cannot join

  • Significant physical or psychological comorbidity considered by the investigator likely to affect study outcomes.
  • Active cardiovascular disease or recent significant cardiovascular event (myocardial infarction within 6 months, cardiac arrhythmias including atrial fibrillation/flutter within 6 months, unstable angina within 6 months, stable angina with current symptoms).
  • Moderate or severe COPD exacerbation within 4 weeks of screening (an exacerbation requiring treatment with steroids and/or antibiotics or leading to hospitalisation).
  • Unable or unwilling to undertake exercise as set out in the study protocol

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Castle Hill Hospital

    Cottingham, East Yorkshire, HU16 5JQ

Other trials in United Kingdom

About this study

Official title: Promoting Activity in Chronic Obstructive Pulmonary Disease (COPD): Optimising High Intensity Interval Training and Technologies, a Pilot Study

Trials in COPD have shown that HIIT leads to the same positive outcomes as constant load training but causes less breathlessness and leg discomfort during training. However, HIIT protocols in existing trials have all been different and use relatively long interval durations (30 s) and short rests. This is sub-optimal because long interval durations lead to greater breathlessness and patients may fear that they will not fully recover during short rests, potentially decreasing adherence. A novel HIIT protocol involving very brief intervals (e.g. 10 s) with longer rests may provide the same benefits with less distress due to breathlessness.

Read the detailed description

Chronic Obstructive Pulmonary Disease (COPD) is a common and disabling smoking-related lung disease that is predicted to become the 3rd leading cause of death world-wide by 2030 (WHO, 2017). The economic burden of COPD in the United Kingdom is estimated by the British Lung Foundation (BLF) to be around £48.5 billion per year - higher than all other respiratory diseases, including lung cancer. Although widespread, Hull is a COPD 'hot spot' (BLF), with prevalence and mortality rates 36% and 75% higher than the national average, respectively. COPD is characterised by symptoms of breathlessness and cough that typically progress over time.

As a consequence of these symptoms, physical activity (PA) is reduced in COPD patients, with lower levels associated with higher symptom burden, hospital admissions and mortality. Breathlessness is the most commonly reported barrier to PA in COPD, resulting in a cycle of deconditioning that ultimately leads to greater breathlessness and disability.

Pulmonary rehabilitation (PR) improves symptoms and increases exercise capacity in COPD but uptake and adherence are poor. Patients with greater breathlessness are less likely to complete PR programmes which is unsurprising given that exercise-induced breathlessness can be distressing in COPD.

One potential solution is high-intensity interval training (HIIT). HIIT involves short bursts of high-intensity exercise interspersed with periods of rest. The short duration of high-intensity exercise can reduce distressing breathlessness during exercise in COPD, mitigating the most common barrier to exercise.

As mentioned above, PR participants benefit from increased exercise capacity. However, what patients can do (exercise capacity) does not always translate into what patients do (PA) and the effect of PR on PA has been disappointing.

Interventions that aim to improve PA in COPD patients have been trialed, but the quality of evidence is low and results inconsistent. Physical inactivity is the strongest predictor of mortality in COPD patients and therefore, effective interventions that increase PA are desperately needed.

Conditions
COPD
Being tested
HIIT exercise program ABC, HIIT exercise program CAB, HIIT exercise program BCA
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.

  • HIIT exercise program ABCOther

    Delivery of 3 different exercise programs to patients with COPD to determine which program gives least breathlessness with the same exercise benefits

  • HIIT exercise program CABOther

    Delivery of 3 different exercise programs to patients with COPD to determine which program gives least breathlessness with the same exercise benefits

  • HIIT exercise program BCAOther

    Delivery of 3 different exercise programs to patients with COPD to determine which program gives least breathlessness with the same exercise benefits

Study groups in NCT05343949
Study groupRoleWhat they receive
HIIT protocol ABCExperimentalHIIT protocol A, then HIIT protocol B, then HiIT protocol C. Patients first received HIIT A -High-intensity duration and intensity: 5 seconds, Rest duration: 40 seconds, Number of Repetitions: 54, Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds). After a rest of at least 2 days they received HIIT B: High-intensity duration and intensity: 10 seconds, Rest duration: 80 seconds, Number of Repetitions: 27, Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds). After a further rest of at least 2 days they received HIIT C-High-intensity duration and intensity: 30 seconds, Rest duration: 240 seconds, Number of Repetitions: 9 Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds).
Receives: Other: HIIT exercise program ABC
HIIT protocol CABExperimentalHIIT protocol C, then HIIT protocol A, and lastly HIIT protocol B. Patients first received HIIT C:-High-intensity duration and intensity: 10 seconds, Rest duration: 80 seconds, Number of Repetitions: 27, Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds). After a rest of at least 2 days they received HIIT A:-High-intensity duration and intensity: 5 seconds, Rest duration: 40 seconds, Number of Repetitions: 54, Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds). After a further rest of at least 2 day they performed HIIT protocol B:-High-intensity duration and intensity: 10 seconds, Rest duration: 80 seconds, Number of Repetitions: 27 Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds).
Receives: Other: HIIT exercise program CAB
HIIT protocol BCAActive comparatorHIIT protocol B, then HIIT protocol C, and lastly HIIT protocol A. Patients firstly received HIIT protocol B:-High-intensity duration and intensity: 10 seconds, Rest duration: 80 seconds, Number of Repetitions: 27, Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds). Following at least 2 days rest the patient will receive HIIT protocol C:-High-intensity duration and intensity: 10 seconds, Rest duration: 80 seconds, Number of Repetitions: 27, Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds). After at least another 2 days rest they will lastly receive Protocol A:-High-intensity duration and intensity: 5 seconds, Rest duration: 40 seconds, Number of Repetitions: 54, Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds).
Receives: Other: HIIT exercise program BCA

What is being measured

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

  1. Comparison of the Change from baseline in mean Borg Dyspnoea scale (the higher the score the worst the breathlessness) following HIIT protocols

    The Dyspnoea Borg scale was assessed at rest and then at the beginning and end of each high intensity interval. during and following each of the HIIT protocols lasting 40 min. the scale ranges from 0-10 with 0 being no breathlessness and 10 being maximum breathlesness

    Measured: Through study completion, on average 2 wks

Secondary outcomes (1)
  1. Comparison of maximum Dyspnoea Borg score for each HIIT protocol (the higher the score the worse the breathlessness

    Assessed the maximum score for Dyspnoea during high intensity training for each of the HIIT protocols with 0 being no breathlessness and 10 the maximum breathlessness.

    Measured: through study completion, on average 2 wks

Timeline

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

  1. First posted25 Apr 2022
  2. Study start8 May 2019
  3. Primary completion25 Nov 2022
  4. Study completion25 Nov 2022

Why it stopped: lead coordinatior has left the site, need to find alternative lead for the study

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
Randomised
Intervention model
Crossover
Model description
Patients will once screened will attend on 3 visits and will perform in a random order all of below protocols: A - High-intensity duration and intensity: 5 seconds Rest duration: 40 seconds Number of Repetitions: 54 Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds) B - High-intensity duration and intensity: 10 seconds Rest duration: 80 seconds Number of Repetitions: 27 Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds) C - High-intensity duration and intensity: 30 seconds Rest duration: 240 seconds Number of Repetitions: 9 Total duration of HIIT protocol: 2,430 seconds (40 minutes, 30 seconds)
Masking
Single blind
Who is masked
Participant
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05343949
Sponsor's protocol ID
01022019
Status last verified
Oct 2023
First submitted
23 Nov 2021
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Watz H, Waschki B, Meyer T, Magnussen H. Physical activity in patients with COPD. Eur Respir J. 2009 Feb;33(2):262-72. doi: 10.1183/09031936.00024608. Epub 2008 Nov 14.

    PubMed 19010994
  • Katajisto M, Kupiainen H, Rantanen P, Lindqvist A, Kilpelainen M, Tikkanen H, Laitinen T. Physical inactivity in COPD and increased patient perception of dyspnea. Int J Chron Obstruct Pulmon Dis. 2012;7:743-55. doi: 10.2147/COPD.S35497. Epub 2012 Oct 29.

    PubMed 23152679
  • Troosters T, van der Molen T, Polkey M, Rabinovich RA, Vogiatzis I, Weisman I, Kulich K. Improving physical activity in COPD: towards a new paradigm. Respir Res. 2013 Oct 30;14(1):115. doi: 10.1186/1465-9921-14-115.

    PubMed 24229341
  • McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.

    PubMed 25705944
  • Hayton C, Clark A, Olive S, Browne P, Galey P, Knights E, Staunton L, Jones A, Coombes E, Wilson AM. Barriers to pulmonary rehabilitation: characteristics that predict patient attendance and adherence. Respir Med. 2013 Mar;107(3):401-7. doi: 10.1016/j.rmed.2012.11.016. Epub 2012 Dec 19.

    PubMed 23261311
  • Candemir İ., Kaymaz D., Ergün P. The reasons for non-adherence in pulmonary rehabilitation programs. Eurasian J. Pulmonol. 2017;19:25-29

  • Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med. 2018 Jun 4;28(1):19. doi: 10.1038/s41533-018-0085-7.

    PubMed 29867117
  • Kortianou EA, Nasis IG, Spetsioti ST, Daskalakis AM, Vogiatzis I. Effectiveness of Interval Exercise Training in Patients with COPD. Cardiopulm Phys Ther J. 2010 Sep;21(3):12-9.

    PubMed 20957074
  • Coronado M, Janssens JP, de Muralt B, Terrier P, Schutz Y, Fitting JW. Walking activity measured by accelerometry during respiratory rehabilitation. J Cardiopulm Rehabil. 2003 Sep-Oct;23(5):357-64. doi: 10.1097/00008483-200309000-00006.

    PubMed 14512781
  • Mantoani LC, Rubio N, McKinstry B, MacNee W, Rabinovich RA. Interventions to modify physical activity in patients with COPD: a systematic review. Eur Respir J. 2016 Jul;48(1):69-81. doi: 10.1183/13993003.01744-2015. Epub 2016 Apr 21.

    PubMed 27103381
  • Waschki B, Kirsten A, Holz O, Muller KC, Meyer T, Watz H, Magnussen H. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest. 2011 Aug;140(2):331-342. doi: 10.1378/chest.10-2521. Epub 2011 Jan 27.

    PubMed 21273294

Questions about this trial

What is this clinical trial studying?

A study testing HIIT exercise program ABC, HIIT exercise program CAB and HIIT exercise program BCA in people with COPD, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

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 6 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: stopped early, as of the sponsor's last update on 11 Apr 2024. 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 United Kingdom. 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?

The study was stopped early (reason given: lead coordinatior has left the site, need to find alternative lead for the study). Results are not available in the source record.

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?

Comparison of the Change from baseline in mean Borg Dyspnoea scale (the higher the score the worst the breathlessness) following HIIT protocols (time frame: Through study completion, on average 2 wks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05343949, which also lists 11 linked publications.

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 11 Apr 2024.

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