An eXercise-based Frailty Intervention in Lung Transplantation (XFIT): A Phase Ib Clinical Trial Focused on Establishing Safety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Death
研究概览
简要总结
The goal of XFIT study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty in lung transplant candidates in their own home. The main questions XFIT aims to answer are:
- Is XFIT safe?
- Is XFIT feasible and acceptable by participants?
- Is XFIT effective in improving frailty and physical function as reflected in patient-reported outcomes.
Participants will:
- Participate in the 8-week XFIT program or enhanced standard of care
详细描述
We will randomize 70 patients who reflect the diversity and spectrum of illness seen in the general lung transplant candidate population to either XFIT or enhanced standard of care. An interventionalist with expertise in exercise physiology and remote interventions will deliver 8 weekly sessions using video-conference software in participants' homes. These sessions feature one-on-one exercise training and targeting of behavioral barriers to optimizing physical activity using motivational interviewing principles. Establishing safety is our primary outcome. We will secondarily establish feasibility and acceptability, and explore responsiveness six-minute walk distance, frailty, Patient Reported Outcomes . We anticipate that this first-of-its kind study in solid organ transplantation will establish fundamental safety, feasibility, and accessibility data needed inform larger scale interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age 18 - 65 years
- •Lung Transplant Candidates
- •Speaks English or Spanish
- •≤ 8LPM O2 on 6MWT
- •SPPB score ≤ 10
排除标准
- •Lives Alone
- •BMI < 18.0 kg/m2
- •Engaged in clinical pulmonary rehabilitation program
- •Severe pHTN (RHC mPAP ≥ 30 mmHg or TTE PASP ≥ 60mmHg or moderately/severely reduced RV systolic function on TTE
- •Deemed unsafe by site PI
- •Inclusion Criteria:
- •Age 18 - 75 years
- •Speaks English or Spanish
- •≤ 15LPM O2 on 6MWT
- •SPPB score ≤ 10
- •Exclusion Criteria:
- •Lives Alone
- •BMI < 18.0 kg/m2
- •Engaged in clinical pulmonary rehabilitation program
- •Severely reduced RV systolic function on TTE
- •Deemed unsafe by site PI
研究组 & 干预措施
XFIT
XFIT is an 8-week telehealth-delivered, home-based exercise/behavior modification intervention. It integrates theoretical frameworks of behavior change to engage frail lung transplant candidates in program of pre-habilitation.
干预措施: XFIT (Behavioral)
Enhanced standard of care
Participants in ESC will be provided with individualized recommendations to improve physical frailty tailored to their baseline assessments, as well as contemporary information on treatments for physical frailty published by the NIH's Science of Frailty group (https://frailtyscience.org/). ESC participants will not engage in weekly treatment sessions, wear activity trackers throughout the intervention period, or receive the personalized psychological treatment provided to those in XFIT.
结局指标
主要结局
Death
时间窗: 8 weeks
Major cardiovascular event
时间窗: 8 weeks
> 2 unplanned hospitalizations
时间窗: 8 weeks
次要结局
- Desaturation(8 weeks)
- Coughing(8 weeks)
- Presyncope(8 weeks)