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

NCT ID: NCT05273684

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-07-01

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High intensity interval training

Intervention Type: OTHER

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

Interventions

High intensity interval training

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Ronan Berg

MD, DMSc, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronan Berg, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

Nymand SB, Hartmann J, Rasmussen IE, Iepsen UW, Ried-Larsen M, Christensen RH, Berg RMG. Fidelity and tolerability of two high-intensity interval training protocols in patients with COPD: a randomised cross-over pilot study. BMJ Open Sport Exerc Med. 2023 Mar 8;9(1):e001486. doi: 10.1136/bmjsem-2022-001486. eCollection 2023.

Reference Type: DERIVED

PMID: 36919122 (View on PubMed)

Other Identifiers

CFAS_2021_1

Identifier Type: -

Identifier Source: org_study_id