ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study. A Feasibility Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Feasibility- proportion of participants willing to be randomized
研究概览
简要总结
The primary aim of this trial is to assess the feasibility of a novel online weight gain prevention resource for new kidney transplant recipients at two London transplant clinics. A previous study conducted by the research team titled 'ExeRTiOn' provided usability feedback that led to revisions of this online resource in a purposive sample of kidney transplant recipients (n=11) and transplant multidisciplinary team members (n=6).
详细描述
This current study aims to recruit a sample of new kidney transplant recipients (n=50) from two transplant sites in London. Participants will be randomized to either the 12-week kidney transplant specific novel online weight gain prevention resource (n=25) or usual care (n=25). All participants will be assessed at baseline, 12 weeks and 12 months. The primary outcome of this study is feasibility (screening, recruitment, randomization, retention, adherence to the intervention and adherence to the study visits). The research team will also assess the ability to collect measures for a definitive study (body weight, body mass index, body composition, quality of life, self-efficacy, fatigue, arterial stiffness and physical function).
A nested qualitative study will capture participant experience at two time points during this 12 month trial. At 3 months semi-structured individual interviews will be conducted in a purposive approximately 6 to 10 of the intervention participants until data saturation is achieved. These interviews will assess the experience of using the online intervention. At 6 months a purposive sample of approximately 16 participants from both groups will complete individual semi-structured interviews to assess the experiences of participating in this trial.
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
- Single (Outcomes 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
- •age 18 or above
- •able to provide written consent
- •less than 3 months post kidney transplant
- •access to the internet connected computer, tablet, laptop or smartphone
- •a body mass index greater than or equal to 18.5 (healthy range)
排除标准
- •age < 18
- •current pregnancy
- •unstable medication condition such as uncontrolled angina
- •participation in a recent structured exercise programme in the last 3 months
- •BMI of less than 18.5 (classified as underweight)
- •significant cognitive impairment preventing them from engaging with the online resource
- •unable to complete the resource in English
结局指标
主要结局
Feasibility- proportion of participants willing to be randomized
时间窗: through study completion, an average of 1 year
willingness of participants to be randomized to each group
feasibility- total retention of participants over the trial period
时间窗: through study completion, an average of 1 year
number of participants retained and at end of study
Feasibility- screening of participants
时间窗: through study completion, an average of 1 year
number of participants screened per month, and those unwilling to take part
feasibility- monthly retention of participants over the trial period
时间窗: through study completion, an average of 1 year
number of participants retained per month
feasibility-adherence to ExeRTiOn online resource (intervention group)
时间窗: by three months
aim for 60% completion of sessions
feasibility- time taken to complete all study visits
时间窗: through study completion, an average of 1 year
the average time taken to complete study visits will be captured
feasibility- adherence to study visits throughout the trial
时间窗: through study completion, an average of 1 year
the proportion of completed study visits for outcome measures will be calculated
feasibility- qualitative experience of participants using the online resource
时间窗: 3 months
individual semi-structured interviews in a purposive sample from the treatment group
feasibility- qualitative experience of participants participation in the trial
时间窗: 6 months
individual semi-structured interviews in a purposive sample of study participants
Feasibility- recruitment of participants into the trial
时间窗: through study completion, an average of 1 year
number of participants recruited per month
feasibility- safety throughout the trial
时间窗: 12 months
the number of hospital admissions (non-elective, or elective staying \>24 hours) will be captured
次要结局
- body mass index over the 12 month trial(baseline, 3 months, 12 months)
- self reported self-efficacy for physical exercise scale over the 12 month trial(baseline, 3 months, 12 months)
- Total score self reported fatigue via the Chalder Fatigue Questionnaire over the 12 months(baseline, 3 months, 12 months)
- body composition over the 12 month trial(baseline, 3 months, 12 months)
- quality of life (self-reported) over the 12 month trial(baseline, 3 months, 12 months)
- change in body weight in kilograms over the trial(baseline, 3 months and 12 months)
- Mental fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months(baseline, 3 months, 12 months)
- physical function over the 12 month trial(baseline, 3 months, 12 months)
- Physical fatigue (sub-scale) of the Chalder Fatigue Questionnaire over the 12 months(baseline, 3 months, 12 months)
- arterial stiffness over the 12 month trial(at baseline, 3 months and 12 months)
- self reported self-efficacy for nutrition scale over the 12 month trial(baseline, 3 months, 12 months)