Clinical trial NCT03800914: High Intensity Interval Training in Fibrotic Interstitial Lung Disease
Official title: High Intensity Interval Training in Fibrotic Interstitial Lung Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibrotic Interstitial Lung Disease
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in endurance time
timeFrame: Baseline, nine weeks and 6 months following intervention
Secondary outcomes:
measure: Change in dyspnea measured using the Dyspnea-12 questionnaire
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Changes in fatigue evaluated by the Fatigue Severity Scale
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Change in functional exercise capacity assessed by 6-minute walk distance
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Changes in skeletal muscle size
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Dyspnea related disability - measured with modified medical research council scale (MMRC)
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Global rating of change
timeFrame: Baseline, nine weeks and 6 months following intervention
measure: Change in physical activity
timeFrame: Baseline, nine weeks and 6 months following intervention
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
Study officials:
affiliation: Monash University
name: Anne Holland
role: STUDY_DIRECTOR
References:
citation: Dowman LM, May AK, Hill CJ, Bondarenko J, Spencer L, Morris NR, Alison JA, Walsh J, Goh NSL, Corte T, Glaspole I, Chambers DC, McDonald CF, Holland AE. High intensity interval training versus moderate intensity continuous training for people with interstitial lung disease: protocol for a randomised controlled trial. BMC Pulm Med. 2021 Nov 10;21(1):361. doi: 10.1186/s12890-021-01704-2.