High Intensity Interval Training and Technologies in COPD

NCT05343949 | Terminated

• 1 other identifier: 01022019
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (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

  Through study completion, on average 2 wks

Secondary Outcomes (1)

• Comparison of maximum Dyspnoea Borg score for each HIIT protocol (the higher the score the worse the breathlessness

  through study completion, on average 2 wks

Study Arms (3)

HIIT protocol ABC

EXPERIMENTAL

HIIT 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).

Other: HIIT exercise program ABC

HIIT protocol CAB

EXPERIMENTAL

HIIT 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).

Other: HIIT exercise program CAB

HIIT protocol BCA

ACTIVE COMPARATOR

HIIT 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).

Other: HIIT exercise program BCA

Interventions

HIIT exercise program ABC OTHER

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

HIIT protocol ABC

HIIT exercise program CAB OTHER

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

HIIT protocol CAB

HIIT exercise program BCA OTHER

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

HIIT protocol BCA

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 19010994 BACKGROUND

• 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.

  PMID: 23152679 BACKGROUND

• 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.

  PMID: 24229341 BACKGROUND

• 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.

  PMID: 25705944 BACKGROUND

• 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.

  PMID: 23261311 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29867117 BACKGROUND

• 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.

  PMID: 20957074 BACKGROUND

• 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.

  PMID: 14512781 BACKGROUND

• 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.

  PMID: 27103381 BACKGROUND

• 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.

  PMID: 21273294 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Random order of the delivery of the HIIT protocol
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: April 25, 2022
• Study Start: May 8, 2019
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: April 11, 2024

Record last verified: 2023-10

Locations

GB (1)