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Clinical Trials/NCT05273684
NCT05273684
Completed
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country12 target enrollmentNovember 1, 2021
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Rigshospitalet, Denmark
Enrollment
12
Locations
1
Primary Endpoint
Exercise tolerability: Subjective rating of the exercise session
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ronan Berg

MD, DMSc, Associate professor

Rigshospitalet, Denmark

Eligibility Criteria

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

Outcomes

Primary Outcomes

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: 1. How tolerable was todays traning? 2. 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: 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 attendance rate

Time Frame: 1 week

Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100

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.

Study Sites (1)

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