iLiFE: a Home-based Physical Activity Programme for Patients With Advanced Interstitial Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Physical activity levels (steps/day) at 12-weeks
研究概览
简要总结
Interstitial lung diseases (ILD) are a highly incapacitating group of chronic respiratory diseases, leading to disabling symptoms and impaired capacity to perform activities of daily living and health-related quality of life (HRQoL). It is known that people with ILD are highly inactive and sedentary, and in a severe stage of the disease, these people spend most of the time at home, increasing dependency on others, and decrease HRQoL. Physical activity is a cost-effective intervention, which increases the HRQoL, exercise capacity and ability to perform activities of daily living in people with chronic respiratory diseases. However, few home-based physical activity programmes are available, especially in people with ILD. Thus, it is urgent to develop innovative models of PA, closer to patients and adjusted to the patients' routines, to engage and change patients' physical activity levels, enhancing HRQoL.
iLiFE might be promising as it focuses on establishing new behaviours, within selected contexts to stimulate home-based PA. Therefore, iLiFE will be developed, implemented and evaluated in people with ILD.
详细描述
Interstitial lung diseases (ILD) comprise the most highly incapacitating group of chronic respiratory diseases, with significant morbidity and high mortality.
Physical activity (PA) improves HRQoL, exercise capacity and performance of activities of daily living, control the symptoms and prevent the development of further comorbidities in people with chronic respiratory diseases. However, people with ILD are highly inactive and sedentary and, as the disease progresses, these people spend most of time at home and adhere poorly to interventions, which worsens HRQoL, intensifies clinical decline and increases dependency on others.
Home-based PA programmes, integrated in patients' daily routines, may increase PA levels. Lifestyle Integrated Functional Exercise (LiFE) is a home-based PA programme, which integrates training into daily routines. This programme has shown to be effective in healthy older, however its effectiveness in people with a chronic respiratory disease population is unknown.
Therefore, this study will develop and implement a home-based PA programme, based on LiFE, in patients with advanced ILD and assess its impacts on PA levels, HRQoL and other health-related domains.
The PRIMARY AIM of this study is to assess the effects (short- and mid-term) of a home-based PA programme, based on the LiFE programme, on PA levels and HRQoL of patients with ILD, through a randomised controlled trial (RCT).
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
Single blind
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
- •clinical diagnosis of a interstitial lung disease
- •clinically stable in the previous month
- •≥ 18 years old
- •Living at home, assisted-home or at familiar home.
排除标准
- •cognitive impairments
- •inability to understand and co-operate
- •history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition
- •Participating in pulmonary rehabilitation or have participated in last 6 months.
结局指标
主要结局
Change in Physical activity levels (steps/day) at 12-weeks
时间窗: Assessment at baseline and 12-week (immediately after iLiFE)
Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day.
Change in Physical activity levels (steps/day) at 3 months
时间窗: Assessment at baseline and 3 months after iLiFE.
Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day.
Change in Physical activity levels (steps/day) at 6 months
时间窗: Assessment at baseline and 6 months after iLiFE.
Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day.
Change in physical activity levels (time spent in sedentary, light, lifestyle, moderate and vigorous physical activities)
时间窗: Multiple time points through study completion - immediately after iLiFE, and up to 3 and 6 months after iLiFE.
Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the daily energy expenditure during one week.
次要结局
- Change in handgrip strength(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in exercise tolerance(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in symptom's impact in patients' life(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in functional status (1-minute sit-to-stand test)(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in self-reported dyspnoea(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in the impact of breathlessness on activities of daily living(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in self-reported fatigue(Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in health-related quality of life - The King's Brief Interstitial Lung Disease (KBILD) questionnaire.(Assessment at baseline, 12-week (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in quadriceps muscle strength(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in emotional state(Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in frequency of exacerbations(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in functional dyspnoea(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in cough and sputum symptoms(Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in healthcare utilization (number of hospital admissions)(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in healthcare utilization (number of participants that visits emergency department)(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in functional status (physical performance test)(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in healthcare utilization (number of visits of each participant)(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in healthcare utilization (duration of hospital admissions)(Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
- Change in fatigue(Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.)
研究者
Alda Sofia Pires de Dias Marques
Senior Lecturer
Aveiro University