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NCT Number: NCT05273684

High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study

Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and tolerability of the two most commonly used HIIT protocols, the classical so-called 4x4min vs. 10x1min in patients with moderate to severe COPD.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women
  • 18-80 years
  • Moderate to severe COPD(GOLD stage II to III)

Exclusion criteria

  • 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
  • Pregnancy

Treatment and study plan

High Intensity Interval Training

Other

Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: COPDEX-HIIT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2022
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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