A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment of patients to study
研究概览
简要总结
To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound
详细描述
This study will be looking at the measurement of body mass composition using bioimpedance analysis (BIA) and quadriceps muscle ultrasound in patients with fibrotic lung disease who are on anti-fibrotic drugs. These anti-fibrotic drugs (nintedanib and pirfenidone) commonly cause gastrointestinal side effects such nausea, loss of appetite and diarrhoea. As a result of these side effects some patients may have a change in the amount of body fat and muscle. This change is not able to be identified using weight or body mass index (BMI). BIA machines are a quick and easy method of looking at body mass composition and require patients to have electrodes attached to their body for approximately 6 seconds. BIA machines are already in routine care for patients with other types of lung conditions. Using muscle ultrasound we will be able to measure the size of the muscle in the thigh.
In addition to the use and tolerability of BIA and muscle ultrasound in this group of patients we will be also taking other measurements including mid-arm circumference and physical tests (sitting to standing, walking speed and muscle strength). We will also use questionnaires to ask about symptoms relating to quality of life, physical activity and gastrointestinal symptoms. Patients will also provide a 3-day diet diary. We will be performing all of the above tests at the beginning before patients start the anti-fibrotic drugs and then again 4 months after starting the drugs and assessing for any changes over this period of time.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •A diagnosis of Idiopathic pulmonary fibrosis or progressive pulmonary fibrosis
- •Newly commencing anti-fibrotic medication (either nintedanib or pirfenidone)
- •Subject aged > 18 years
- •Able to willingly give consent
排除标准
- •Co-morbidities currently requiring enteral feeding
- •Weight loss > 10% in preceding 3-6 months
- •Significant musculoskeletal issues that may impact muscle mass
- •End of life care (expected < 6 weeks left to live)
- •Previous anti-fibrotic use
- •Currently on > Prednisolone 10mg daily
- •Presence of implantable cardioverter defibrillator (ICD) or permanent pacemaker (PPM)
- •Heart failure
- •Pregnancy
结局指标
主要结局
Recruitment of patients to study
时间窗: For study recruitment window of 6 months
Measured by number of patients consenting/number of patients contacted and rationale for declining
Implementation of study protocol
时间窗: For the 6 month recruitment window
Number of patients attending both visits (baseline and 4 months) and rationale for dropout
Feasibility of collection of data
时间窗: For the the study recruitment window of 6 months
Collection of data from BIA (skeletal muscle index (SMI), phase angle (PhA) and fat free mass index (FFMI)) and muscle ultrasound (Anterior-posterior diameter of rectus femoris and cross sectional area of rectus femoris)
Acceptability of use of BIA and muscle ultrasound
时间窗: To be performed at baseline visit and 4 month visit
Likert scale on use of BIA and muscle ultrasound
次要结局
- Five times sit to stand (5TST)(To be performed at baseline visit and at 4 month visit)
- Four metre gait speed (4MGS)(To be performed at baseline visit and 4 month visit)
- Body weight(Performed at baseline visit and 4 month visit)
- Bioelectrical impedance analysis (BIA)(Performed at baseline visit and at 4 month visit)
- Questionnaires assessing respiratory symptoms and quality of life(To be performed at baseline visit and at 4 month visit)
- Questionnaires assessing gastrointestinal symptoms(To be performed at baseline visit and at 4 month visit)
- Questionnaire to assess levels of physical activity(To be performed at baseline visit and at 4 month visit)
- Muscle strength(Performed at baseline visit and 4 month visit)
- Height(To be performed at baseline)
- Quadriceps ultrasound(To be performed at baseline visit and 4 month visit)