Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Tolerance evaluation
研究概览
简要总结
This study compare an usual training program (in continuous endurance) with an ITHI program over a period of 3 weeks, in France. The aim is to evaluate the safety and feasibility of this type of program in CF adults, and also more specifically, in subgroups:
patients divided according to the severity of their FEV1 ; patients treated with modulating CFTR canal therapy ; diabetic patients on insulin ; undernourished patients.
详细描述
Objectives Studies have shown good tolerance of High Intensity Interval Training (ITHI) in healthy people or in COPD with similar results obtained with continuous training regimen, but with less shortness of breath and muscle fatigue, greater pleasure and a positive impact on glycemia. Research in CF is still scarce.
We propose to compare our usual training program (in continuous endurance) with an ITHI program over a period of 3 weeks, corresponding to the length of the rehabilitation stay in France. Our aim is to evaluate the safety and feasibility of this type of program in CF adults, and also more specifically, in subgroups:
- patients divided according to the severity of their FEV1
- patients treated with modulating CFTR canal therapy
- diabetic patients on insulin
- undernourished patients (BMI ≤ 18.5)
Methodology
- Bicentric (Roscoff-Giens); prospective; opened; randomized; controlled
- Rehabilitation stay in hospitalization with 18 days of training, on an ergometer, supervised by an APA teacher or a physiotherapist
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
- None
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
- •men and women aged over 18 years of age on the date of informed consent
- •diagnosed CF patients
- •not transplanted and not on the transplant waiting list
- •able to participate in the proposed training programs (especially without cardiac contraindication)
- •able to understand and respect the protocol and its requirement
- •who signed the consent prior to any other procedure protocol
排除标准
- •major patients under guardianship / curatorship / legal protection
- •pregnant patients
- •dialysis patients
- •patients with a severe exacerbation at the time of inclusion
- •patients for whom a new modulating treatment (eg.: Kaftrio®, Kalydeco®, Symkevi®, etc.) has been implemented in the 4 weeks preceding inclusion
- •patients with pulmonary arterial hypertension (≥ 25 mmHg)
- •patients unable to complete the entire program
结局指标
主要结局
Tolerance evaluation
时间窗: Change from baseline (Day 2) at 3 weeks (Day 18)
Scores on the Borg scale (physical activity dyspnea and muscle fatigue) : 0 to 10 - Higher score = worse outcome
Feasability evaluation
时间窗: Continuous measurement over the entire stay (Day 1 to Day 18)
Proportion of sessions carried out according to the planned program (and, in parallel, number and reasons for stopping sessions or the program)
次要结局
- Hospital Anxiety and Depression scale (HAD)(Change from baseline (Day 2) at 3 weeks (Day 18))
- Anthropometry(Change from baseline (Day 1) at 3 weeks (Day 18))
- Cystic Fibrosis Questionnaire Revised (CFQR)(Change from baseline (Day 2) at 3 weeks (Day 18))
- Starfish(Change from baseline (Day 2) at 3 weeks (Day 18))
- Ponctual blood sugar levels(Measurement at each sessions from Day 2 to Day 18)
- Physical Activity Enjoyment Scale (PACES)(Measurement at the end of the stay (Day 18))
- Maximal Voluntary force : Strength(Change from baseline (Day 2) at 3 weeks (Day 18))
- Impedance(Change from baseline (Day 2) at 3 weeks (Day 18))
- Spirometry(Change from baseline (Day 2) at 3 weeks (Day 18))
- 6MWT(Change from baseline (Day 12) at 3 weeks (Day 18))
- Continuous blood sugar levels(Continuous measurement over the entire stay (Day 1 to Day 18))
- Maximal Voluntary force : endurance(Change from baseline (Day 2) at 3 weeks (Day 18))
- Multidimensional dyspnea profile scale (MDP)(Change from baseline (Day 2) at 3 weeks (Day 18))