Pulmonary Adaptive Responses to HIIT in COPD

NCT05552833 | Unknown

• 1 other identifier: COPDEX0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise can improve quality of life in these patients, but the health care system lack the underlying mechanism of exercise-induced improvement in COPD and it is widely thought not to have any effect on lung function. The aim of the present study is to investigate to which extent lung tissue mass and rest-to-exercise diffusion capacity changes differ in COPD patients compared to the healthy state. In order to design prospective clinical trials on the putative impact of high-intensity interval training (HIIT) investigating these parameters, and a secondary aim is to assess the feasibility of such a study in terms of patient inclusion, adherence and methodology.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

High intensity interval training (HIIT); Lung growth; Diffusion capacity; Blood flow; Lung tissue mass; Oxygen extraction

Outcome Measures

Primary Outcomes (2)

• Lung tissue mass

  Change in lung weight in COPD patients compared to matched controls using CT-scans.

  CT-scans at baseline and at 12 week follow up.

• Rest-to-exercise diffusion capacity

  Change in rest-to-exercise pulmonary diffusion capacity between COPD patients and matched healthy controls measured by DLNO/CO.

  DLNO/CO measured at baseline and at 12 week follow up.

Secondary Outcomes (2)

• Rest-to-exercise pulmonary perfusion ratio change

  At baseline and at 12 week follow up

• Rest-to-exercise leg blood flow change in COPD

  At baseline and at 12 week follow up

Other Outcomes (38)

• Rest-to-exercise cardiac output change

  At baseline and at 12 week follow up

• VO2peak (and estimated VO2max)

  At baseline and at 12 week follow up

• VO2 verification bout

  At baseline and at 12 week follow up

Study Arms (2)

COPD patients

EXPERIMENTAL

This arm will consist of only COPD patients.

Other: High intensity interval training

Healthy controls

EXPERIMENTAL

This arm will consist of age and BMI matched healthy controls.

Other: High intensity interval training

Interventions

High intensity interval training OTHER

Participants will undergo 12 weeks of supervised HIIT training (3 times per week). The HIIT protocol will consist of 4x4 min.

COPD patients; Healthy controls

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• years
• COPD (GOLD stage I to III)
• Forced expiratory volume in 1 sec (FEV1)/forced vital capacity ratio (FVC) \< 0.8, FEV1 \< 90% of predicted value
• Modified Medical Research Council score (mMRC 0 - 3)
• Resting arterial oxygenation \> 90%
• Do not fulfil the physical activity recommendations by the Danish Health Authority
• Men and women
• years
• Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
• Same sex, age (± 3 years) and BMI (± 10%)
• Do not fulfil the physical activity recommendations by the Danish Health Authority (19)
• BMI 18-35

You may not qualify if:

• Symptoms of ischaemic heart disease
• Known heart failure
• Previous severe or current COVID-19
• Unable to complete or understand HIIT training
• Claudication
• Symptoms of disease within 2 weeks prior to the study
• Participation in pulmonary rehabilitation within 6 months
• Known malignant disease
• Pregnancy
• Unstable cardiac arrhythmic disease
• Renal or liver dysfunction
• COPD
• Asthma
• Known ischaemic heart disease
• Known heart failure

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Centre for Physical Activity Research (CFAS)

Copenhagen, 2100, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ronan Martin Griffin Berg, MD

CONTACT

(+45) 3545 7641; ronan.martin.griffin.berg@regionh.dk

Jacob Peter Hartmann, MD

CONTACT

40924285; jacob.peter.okholm.hartmann.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, Associate Professor, Principal investigator

Model Details: 12 COPD will undergo the intervention in one arm and 12 healthy, age and BMI matched individuals will undergo the same intervention.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 23, 2022
• Study Start: September 5, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

DK (2)