Clinical trial NCT06677021: Understanding Physical Activity and Quality of Life in Children and Young People with Chronic Kidney Disease
Official title: Evaluation of Physical Activity Behaviours, and Psychosocial Health Outcomes in Children and Young People with Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stages 3-5
Keywords: Children and Young People
Chronic Kidney Disease
Physical activity
Psychosocial outcomes
Quality of life
Adolescents
Children
Exercise
Mental Health
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Primary outcomes:
measure: Physical Activity: cardiorespiratory fitness
timeFrame: Baseline
measure: Physical Activity: forearm strength
timeFrame: Baseline
measure: Physical Activity: muscular endurance
timeFrame: Baseline
measure: Accelerometer
timeFrame: Baseline
Secondary outcomes:
measure: Frequency of physical activity
timeFrame: Baseline
measure: Frequency of physical activity
timeFrame: Baseline
measure: Quality of Life
timeFrame: Baseline
measure: Fatigue
timeFrame: Baseline
measure: Mental Health
timeFrame: Baseline
measure: Strengths and Difficulties
timeFrame: Baseline
measure: Qualitative exploration of experiences, attitudes, and preferences
timeFrame: within 1-2months after primary outcomes have been completed
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Hospital for Children
Study officials:
References: