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Contact Information:

Dr Roberto Rabinovich
+44 1312427370
roberto.rabinovich@nhslothian.scot.nhs.uk


Mr Jaime Ricardo Jimenez Salazar
+44 7395680751
s1879414@ed.ac.uk


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Be Part of Research - Trial Details - Comparing the effects of high-intensity interval training (HIIT) with different oxygen delivery methods in patients with pulmonary fibrosis
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Comparing the effects of high-intensity interval training (HIIT) with different oxygen delivery methods in patients with pulmonary fibrosis

Not Recruiting

Open to: All Genders

Age: Adult

Edinburgh

Medical Conditions

Fibrosing interstitial lung disease

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Interstitial lung disease (ILD) refers to a range of lung conditions that cause inflammation and damage. People with ILD experience a drop in their blood oxygen levels during physical activity, which limits their ability to carry out daily tasks. Pulmonary rehabilitation (PR) is a treatment for ILD patients, but the decrease in oxygen levels poses a challenge to achieving favorable outcomes. Therefore, we aim to investigate whether a combination of High-Intensity Interval Training (HIIT) and High Flow Nasal Oxygen (HFNO) can enhance exercise capacity in ILD patients. We believe that this training method, along with increased oxygen supply, may mitigate the decline in blood oxygen levels and improve exercise tolerance. This approach could serve as an alternative during pulmonary rehabilitation, potentially leading to better treatment results.
The primary objective of this study is to assess the impact of an 8-week program involving HIIT with HFNO on the exercise capacity of ILD patients compared to standard PR. We will evaluate exercise capacity using a bicycle exercise test at a constant work rate, set at 75% of the maximum workload achieved from a previous Cardiopulmonary Exercise Test (CPET). The secondary objectives include examining the effects of this training on daily physical activity levels, quadriceps muscle strength, quality of life using the St George's Respiratory Questionnaire (SGRQ), anxiety and depression levels using the Hospital Anxiety and Depression Scale (HADS), dyspnea sensation, and lung function. Furthermore, we will explore the impact on specific blood biomarkers associated with fibrosis, selected from the ELFMEN study, which have been linked to disease progression. Additionally, we will compare the results of patients receiving antifibrotic medications with those who are not receiving such treatment.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2023 06 Sep 2024

In general, the study will consist of 8 weeks of intervention in the clinic plus 1 day of evaluations before and after the intervention. Spending 1 hour per day, three times a week every second day during the intervention and 2 hours during the other 2 days of evaluations approximately. The window between the baseline appointment and the first day of the intervention can be from 1 to 30 days, and the window between the last day of intervention and the post-intervention appointment will be from 8 to 38 days. All the visits will take place in ward 204 (Respiratory Medicine) of the Royal Infirmary of Edinburgh (for participants from Edinburgh) and in the Royal Victoria Infirmary, Newcastle upon Tyne Hospital (for participants from Newcastle).
The following measurements will be conducted:
During the first day before the intervention, a blood test will be taken (only 6 ml) to know the levels of blood biomarkers associated with fibrosis that have been shown to be associated with disease progression (Inc. but not restricted to PAI-1, VEGF-A, PDGF-AA, PDGF-BB, Cystatin-C, Angiopotein-1, HE4/WFDC-2). Additionally, a test called the quadriceps maximal voluntary contraction test (QMVCT) will be taken to measure the strength of the quadriceps muscle. The subjects are studied seated in a chair, with hip and knee flexion of 90 degrees. An inextensible strap is placed around the ankle, and adjusted to ensure the knee remains at 90 degrees flexion. The ankle strap is connected to a strain gauge mounted on the back of the chair. A seatbelt is secured across the subject’s hips to stabilise the pelvis. The patient has to do a knee extension and we can measure their strength.
In addition, the shortness of breath will be assessed using the Modified version of the Medical Research Council scale (mMRC).

In addition, height and weight will be taken. Breathing tests will not be performed, because these procedures the participants have already done in the outpatient clinic.

In addition, a Cardiopulmonary Exercise Test (CPET) will be carried out.

Furthermore, a Constant work rate Cycle Test at 75% of the peak work rate (obtained from a maximal exercise test conducted beforehand) will be carried out. The participants will be able to rest for about 20 minutes between each test and we will offer them refreshments.

Physical activity levels in daily life will also be measured using an Actigraph GT3x activity monitor, which will be delivered during the baseline appointment to use in their house for only 1 week before and 1 week after the intervention, this is a belt that the participants will have to use like any other. After the intervention, they should return it to us during their post-intervention appointment.

Moreover, two questionnaires called St George’s Respiratory Questionnaire (SGRQ) and the Hospital Anxiety and Depression Scale (HADS), will have to be answered to measure the quality of life and anxiety and depression levels respectively. These tests will be answered at home.

During the first day after the intervention, participants will be undergone exactly the same tests as in the baseline appointment, except for height

Intervention, a group of participants will be submitted to 8 weeks of a PR program based on HIIT plus HFNO and the other group will also be submitted to 8 weeks of a PR program based on HIIT but with conventional oxygen delivery without HFNO. Which group will use HFNO or conventional oxygen will be randomly selected from a sealed envelope.


All patients affected with interstitial lung diseases referred to the physiotherapy department to receive pulmonary rehabilitation in the Lothian region who are between 18 and 85 years old and with the ability to give informed consent will be able to participate.

You can take part if:



You may not be able to take part if:


1. Emphysema greater than extent of fibrosis on high resolution computed tomography (HRCT) of the thorax.2. FEV1/FVC ratio < 70%.3. Involvement in the planning and/or conduct of the study.4. Participants should not be taking part in other interventional studies.5. Patient is unable to attend the assessment sessions or would like to withdraw from the study.6. Absolute contraindications for cardiopulmonary exercise testing, which are: 6.1. Unstable angina 6.2. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise.6.3. Syncope.6.4. Active endocarditis.6.5. Acute myocarditis or pericarditis.6.6. Symptomatic severe aortic stenosis.6.7. Uncontrolled heart failure.6.8. Acute pulmonary embolus or pulmonary infarction.6.9. Thrombosis of lower extremities.6.10. Suspected dissecting aneurysm.6.11. Uncontrolled asthma.6.12. Pulmonary edema.6.13. Room air desaturation at rest ≤ 85%6.14. Respiratory failure.6.15. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)6.16. Mental impairment leading to inability to cooperate.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Infirmary of Edinburgh
    51 Little France Crescent Old Dalkeith Rd
    Edinburgh
    EH16 4SA

The information gained from the participation of the patients may enable us to come up with the most optimal rehabilitation programme in the future, and this may benefit patients with ILD. Their results from the assessments we perform will also be made available to them and their general practitioner with their consent. We will inform them and their GP if anything with clinical relevance is found. During a CPET, participants might experience the following: breathlessness or leg fatigue. They can stop the test at any time. Other more infrequent symptoms may develop during exercise such as chest pain, a drop in blood oxygen levels, drop or increment in their blood pressure. We will be monitoring these and we may decide to stop the test if we feel this is a risk. A clinician will be available to deal with any problem.

Mr Jaime Ricardo Jimenez Salazar
+44 7395680751
s1879414@ed.ac.uk


Dr Roberto Rabinovich
+44 1312427370
roberto.rabinovich@nhslothian.scot.nhs.uk



The study is sponsored by University of Edinburgh and funded by Chilean National Scholarship Program for Graduate Studies (ANID).



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Read full details for Trial ID: ISRCTN76572442
Last updated 10 September 2024

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