Understanding Physical Activity and Quality of Life in Children and Young People with Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease Stages 3-5. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Physical Activity Behaviours, and Psychosocial Health Outcomes in Children and Young People with Chronic Kidney Disease
Overview
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.
Detailed description
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.
1. Phase 1 consists of a battery of in-person physical functioning tests. 2. Phase 2 consists of an online survey of validated questionnaires. 3. 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.
In phase 3, participants from phase 1 will return and take part in an interview to gain deeper insights into psychosocial influences and limitations in engaging in physical activity as well as gaining a better understanding of the impact of CKD on psychosocial wellbeing.
Interventions
- Behavioral Exercise
Physical activity promotion and engagement
Primary outcome measures
- Physical Activity: cardiorespiratory fitness [Time frame: Baseline]
- Physical Activity: forearm strength [Time frame: Baseline]
- Physical Activity: muscular endurance [Time frame: Baseline]
- Accelerometer [Time frame: Baseline]
Secondary outcome measures (7)
- Frequency of physical activity [Time frame: Baseline]
- Frequency of physical activity [Time frame: Baseline]
- Quality of Life [Time frame: Baseline]
- Fatigue [Time frame: Baseline]
- Mental Health [Time frame: Baseline]
- Strengths and Difficulties [Time frame: Baseline]
- Qualitative exploration of experiences, attitudes, and preferences [Time frame: within 1-2months after primary outcomes have been completed]
Eligibility criteria
Inclusion criteria
- CYP of school age between 6 and 18 years
- Living and receiving care in Scotland for CKD
- no clinical contradictions to physical function assessments
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- Glasgow Royal Hospital for Children — Glasgow
Identifiers
NCT: NCT06677021 · BUR 23-23