High Intensity Interval Training in Fibrotic Interstitial Lung Disease

NCT03800914 | Completed DMC

• 1 other identifier: LTU HIIT in ILD
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 4

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.

Conditions

Fibrotic Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Change in endurance time

  Endurance time measured during constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).

  Baseline, nine weeks and 6 months following intervention

Secondary Outcomes (10)

• Change in dyspnea measured using the Dyspnea-12 questionnaire

  Baseline, nine weeks and 6 months following intervention

• Changes in fatigue evaluated by the Fatigue Severity Scale

  Baseline, nine weeks and 6 months following intervention

• Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)

  Baseline, nine weeks and 6 months following intervention

• Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)

  Baseline, nine weeks and 6 months following intervention

• Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale

  Baseline, nine weeks and 6 months following intervention

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

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.

Other: High intensity interval training

Traditional pulmonary rehabilitation

ACTIVE COMPARATOR

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.

Other: Traditional pulmonary rehabilitation

Interventions

High intensity interval training OTHER

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

High Intensity Interval Training

Traditional pulmonary rehabilitation OTHER

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

Traditional pulmonary rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead

Study Sites (4)

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 34758808 DERIVED

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

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

Study Officials

• Anne Holland

  Monash University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: July 17, 2019
• Primary Completion: April 4, 2024
• Study Completion: December 4, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)