High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study (COPDEX-HIIT)
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|ClinicalTrials.gov Identifier: NCT05273684|
Recruitment Status : Completed
First Posted : March 10, 2022
Last Update Posted : October 17, 2022
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|Condition or disease||Intervention/treatment||Phase|
|COPD||Other: High intensity interval training||Not Applicable|
12 patients with severe to moderate COPD will be included in the study, where two different HIIT interventions will be compared with regards to fidelity and tolerability. Baseline measurements will be performed to assess fitness and cardiopulmonary health status for the included patients. The baseline measurements include a medical health interview and examination (blood pressure, heart rate, ECG), a maximal oxygen consumption (VO2max) test, lung function testing (dynamic spirometry, whole body plethysmography, diffusing capacity), and an assessment of body composition. The following two visits consist of two different HIIT protocols.
Each training session is evaluated by Borg Scale (5) and the Likert Scale (6), as well as time spent in with a heart rate above 85% of maximum. Each HIIT session is separated by at least a 3-day wash-out period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study|
|Actual Study Start Date :||November 1, 2021|
|Actual Primary Completion Date :||July 1, 2022|
|Actual Study Completion Date :||July 1, 2022|
Experimental: 4*4 followed by 10*1 or 10*1 followed by 4*4
Following baseline measurements, participants are allocated to the random sequence, by which they will complete the two HIIT protocols ⟨http://www.randomization.com⟩ and based on this, patients are randomized to a specific testing sequence.
Other: High intensity interval training
Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.
- Exercise feasibility: Relative dose intensity (RDI) of exercise [ Time Frame: 1 week ]
RDI (%) of exercise, defined as prescribed exercise dose / performed exercise dose x 100
Evaluated with a Red-Amber-Green system:
- Green: If ≥85% of the training is completed
- Amber: If 50-85% of the training is completed
- Red: If ≤ 50% of the training is completed
- Exercise feasibility: Exercise sessions requiring dose modifications [ Time Frame: 1 week ]Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.
- Exercise tolerability: Subjective rating of the exercise session [ Time Frame: 1 week ]
Tolerability is measured with a 10-point Likert scale, where the participants evaluate the two HIIT protocols.
They will anser two quesitens:
- How tolerable was todays traning?
- How much did you enjoy todays training? Where 1 means not at all, and 10 means alot.
The Likert scale is scored as:
Red: 1-2 Amber: 3-4 Green: +5
- Exercise feasibility: Exercise sessions attendance rate [ Time Frame: 1 week ]Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Men and women
- 18-80 years
- Moderate to severe COPD(GOLD stage II to III)
- Known ischaemic heart disease
- Known heart failure
- Previous or current coronavirus disease 2019 (COVID-19)
- Dementia or other severe neurological disease
- Known vascular
- Symptoms of disease within 2 weeks prior to the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273684
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Ronan Berg, MD||Rigshospitalet, Denmark|
|Responsible Party:||Ronan Berg, MD, DMSc, Associate professor, Rigshospitalet, Denmark|
|Other Study ID Numbers:||
|First Posted:||March 10, 2022 Key Record Dates|
|Last Update Posted:||October 17, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|