High Intensity Interval Training in Fibrotic Interstitial Lung Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 8
- 主要终点
- Change in endurance time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessor
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibrotic interstitial lung disease (fILD)
- •Able to read and speak English
排除标准
- •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
结局指标
主要结局
Change in endurance time
时间窗: Baseline, nine weeks and 6 months following intervention
Endurance time measured during constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).
次要结局
- 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 chronic respiratory disease questionnaire (CRQ)(Baseline, nine weeks and 6 months following intervention)
- Dyspnea related disability - measured with modified medical research council scale (MMRC)(Baseline, nine weeks and 6 months following intervention)
- Global rating of change(Baseline, nine weeks and 6 months following intervention)
- Change in dyspnea measured using the Dyspnea-12 questionnaire(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 anxiety and depression measured by the Hospital Anxiety and Depression Scale(Baseline, nine weeks and 6 months following intervention)
- Change in functional exercise capacity assessed by 6-minute walk distance(Baseline, nine weeks and 6 months following intervention)
- Changes in skeletal muscle size(Baseline, nine weeks and 6 months following intervention)
- Change in physical activity(Baseline, nine weeks and 6 months following intervention)
研究者
Anne E Holland PhD, FThorSoc
Professor
Monash University
