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High Intensity Interval Training in Fibrotic Interstitial Lung Disease

Study Purpose

The fibrotic interstitial lung diseases (fILD) is a group of debilitating chronic lung conditions that are characterised by scarring of lung tissue, dyspnoea on exertion and significant physical impairment. Exercise training is recommended for people with fILD in improving breathlessness and exercise tolerance. However, despite the best efforts of patients and clinicians, many of those who participate are not attaining its benefits. The current exercise training strategies of moderate intensity continuous training may not be well suited to fILD. High intensity interval training (HIIT), short bouts of high-intensity exercise regularly interspersed with periods of rest or light exercise may be an alternate exercise training option for people with fILD. The study will determine to whether HIIT is better than the current method of continuous exercise training at moderate intensity in improving exercise tolerance, breathlessness and quality of life in people with fILD. A randomised controlled, assessor blinded trial will be conducted. A total 130 people with fILD will be randomly assigned to moderate intensity continuous training or HIIT. If this trial demonstrates that HIIT is effective, it will provide an exercise training strategy that can readily be implemented in practice that will maximise the outcomes of exercise training for people with fILD.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of fibrotic interstitial lung disease (fILD) - Able to read and speak English.

Exclusion Criteria:

- Resting oxygen saturation (SpO2) is < 85% - Severe pulmonary hypertension (WHO class IV) - Attendance at Pulmonary rehabilitation (PR) within last 12 months.

- Comorbidities which preclude exercise training.

- History of syncope on exertion.

- Significant cognitive impairment.

- Anticipated transplant or death within the duration of the study period

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03800914
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Monash University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Anne Holland
Principal Investigator Affiliation	Monash University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibrotic Interstitial Lung Disease

Additional Details

Interstitial lung disease (ILD) is a chronic lung condition characterized by scarring of lung tissue. This stiffening of the lungs impairs breathing and reduces the amount of oxygen being delivered throughout the body limiting the ability to perform daily and physical activity. Around two-thirds of people with ILD have fibrotic ILD (fILD), a type of ILD, which typically has worse impairment and disability than other types of ILD. There is no cure for these conditions, although there are two new pharmacological therapies that slow the decline in lung function in Idiopathic Pulmonary Fibrosis (IPF), the most common type of fILD. These treatments however do not provide improvement in breathlessness, exercise capacity or health-related quality of life (HRQoL). Exercise training, or Pulmonary Rehabilitation (PR), has shown to be effective at improving exercise tolerance and HRQoL in ILD. The investigators recently demonstrated that, at a group level, exercise training exerts a positive effect across varying subtypes of ILD, including IPF, the most rapidly progressive of all the fILDs. However less than half of those with IPF who undertook the exercise training achieved meaningful improvements in exercise capacity. In addition, a large proportion of people with IPF were unable to keep up with the recommended exercise training level, often due to excessive dyspnoea or desaturation. This suggests the current exercise training strategies used in PR, which were adopted from guidelines for patients with chronic obstructive pulmonary disease (COPD), may not provide the optimal exercise stimuli for fILD. High intensity interval training (HIIT), which is short bouts of high intensity exercise regularly interspersed with periods of rest or light exercise, may be an alternate exercise training option for people with fILD. However, it is unknown whether this kind of exercise training achieves superior benefits to the traditional model of PR. The aim of this project is to determine whether HIIT is better than the current method of continuous exercise training at moderate intensity, in improving exercise capacity, breathlessness and HRQoL in people with fILD. A total 130 people with fILD will be recruited. The trial will be conducted at four hospital sites across Australia. People who agree to take part in the study will be randomly allocated into two groups. Group 1 will undergo the traditional PR model of moderate intensity continuous exercise training and group 2 will undergo HIIT. Participants in both groups will participate in exercise training twice weekly for eight weeks. The participants will be monitored continuously during exercise by an experienced physiotherapist or exercise physiologist. At the beginning and the end of the eight weeks of exercise training, and six months later, participants will undergo measurements of exercise capacity and health status. This study will determine whether HIIT is effective, providing an important exercise training strategy that can be readily used for people with fILD to achieve positive benefits from PR.

Arms & Interventions

Arms

Experimental: High Intensity Interval Training

Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 36 minutes of interval aerobic exercise on a cycle ergometer alternating every 30 seconds between 100% of peak work rate, achieved on the cardiopulmonary exercise test (CPET), plus upper and lower resistance training.

Active Comparator: Traditional pulmonary rehabilitation

Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 30 minutes of continuous aerobic exercise on a cycle ergometer at 60% of the peak work rate achieved on the CPET, plus upper and lower resistance training.

Interventions

Other: - High intensity interval training

36 minutes of interval exercise on cycle ergometer alternating every 30 seconds between 100% peak work rate achieved on cardiopulmonary exercise test and unloaded cycling

Other: - Traditional pulmonary rehabilitation

30 minutes of continuous exercise on cycle ergometer at 60% peak work rate achieved on cardiopulmonary exercise test.

Contact a Trial Team

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