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

COPD Clinical Trial

— COPDEX-HIIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05273684
• Other study ID #: CFAS_2021_1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• High intensity interval training
Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise feasibility: Relative dose intensity (RDI) of exercise	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	1 week
Primary	Exercise feasibility: Exercise sessions requiring dose modifications	Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.	1 week
Primary	Exercise tolerability: Subjective rating of the exercise session	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	1 week
Primary	Exercise feasibility: Exercise sessions attendance rate	Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100	1 week