Evaluation of Physical Activity Behaviours, and Psychosocial Health Outcomes in Children and Young People with Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Physical Activity: cardiorespiratory fitness
研究概览
简要总结
Children and young people (CYP) with chronic kidney disease (CKD) say that physical activity, school, social activities and tiredness are the main issues they want to improve. As CKD in CYP is a rare disease, there is not much research into understanding these aspects, making it difficult to know how to support patients better. This project aims to investigate how physically active CYP with CKD are, and what psychosocial factors are affected by their illness. CYP aged 6-18 will take part in a battery of physical activity tests, par-take in an online survey looking at physical activity, quality of life, mental health, fatigue and strengths and difficulties, and take part in an interview to better understand what it is like to live with CKD.
详细描述
The aim of this research is to document and evaluate the relationship between physical activity patterns and behaviours and psychosocial outcomes in children and young people with CKD. A second aim is to explore through qualitative methods contextual factors that may explain the type, direction and nature of relationships identified in the quantitative phase.
This research will be conducted in multiple phases to maximise recruitment.
- Phase 1 consists of a battery of in-person physical functioning tests.
- Phase 2 consists of an online survey of validated questionnaires.
- Phase 3 consists of online or in-person interviews with CYP
Participants recruited through NHS Scotland will take part in all 3 phases. Only Phase 2 (online survey) will additionally be disseminated through patient organisations across the UK to maximise recruitment.
In phase 1, participants will take part in a battery of physical activity functioning assessments including multistage bleep tests, sit-up tests, and handgrip tests. Participants will also be given an accelerometer measure to track movements over 7 days. Participants taking part in this phase will also complete the phase 2 online survey which includes a physical activity, Quality of life, Fatigue, Strength and Difficulties, and Mental health questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CYP of school age between 6 and 18 years
- •Living and receiving care in Scotland for CKD
- •no clinical contradictions to physical function assessments
排除标准
- •Enrolment in other clinical trials in which treatment is masked/blinded
- •Deemed to be clinically unstable by treating physician for participating in physical activity and exercise
- •Severe cognitive impairment (as will be unable to give consent)
- •Aged <6 or >18 years.
结局指标
主要结局
Physical Activity: cardiorespiratory fitness
时间窗: Baseline
Multistage Bleep Test - This test entails a progressively incremental jogging/running challenge along a 20-meter distance while keeping to an auditory signal. The test is terminated when participants cannot maintain pace to the auditory signal or upon participant refusal to continue.
Physical Activity: forearm strength
时间窗: Baseline
Handgrip test - This test assesses static forearm strength using a handheld dynamometer.
Physical Activity: muscular endurance
时间窗: Baseline
Sit-up test - This test will assess muscular endurance, particularly abdominal strength (dynamic trunk strength).
Accelerometer
时间窗: Baseline
Participants will be given an accelerometer to be worn around their wrist. This device tracks step counts continuously for 7-days. Average daily step counts, and average sedentary time will be calculated.
次要结局
- Quality of Life(Baseline)
- Fatigue(Baseline)
- Mental Health(Baseline)
- Strengths and Difficulties(Baseline)
- Qualitative exploration of experiences, attitudes, and preferences(within 1-2months after primary outcomes have been completed)
- Frequency of physical activity(Baseline)
研究者
Pelagia Koufaki, PhD
Reader in Exercise Physiology and Rehabilitation Sciences
Queen Margaret University