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NCT Number: NCT06677021

Understanding Physical Activity and Quality of Life in Children and Young People with Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Stages 3-5 Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glasgow Royal Hospital for Children

Glasgow, United Kingdom

Location contact

Reynolds

CONTACT

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Physical activity promotion and engagement

Other names: Quality of life

Primary outcomes

  1. Physical Activity: cardiorespiratory fitness

    Time frame: 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.

  2. Physical Activity: forearm strength

    Time frame: Baseline

    Handgrip test - This test assesses static forearm strength using a handheld dynamometer.

  3. Physical Activity: muscular endurance

    Time frame: Baseline

    Sit-up test - This test will assess muscular endurance, particularly abdominal strength (dynamic trunk strength).

  4. Accelerometer

    Time frame: 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.

Secondary outcomes

  1. Frequency of physical activity

    Time frame: Baseline

    The Physical Activity Questionnaire for older children (PAQ-C) aged 8-14 will be used to measure general levels of PA throughout the school year.

    Physical activity summary score will be calculated on a scale from 1-5. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.

  2. Frequency of physical activity

    Time frame: Baseline

    The Physical Activity Questionnaire for adolescents (PAQ-A) aged 14-18 will be used to measure general levels of PA throughout the school year.

    Physical activity summary score will be calculated on a scale from 1-5. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.

  3. Quality of Life

    Time frame: Baseline

    The multidimensional Paediatric Quality of Life Inventory (PedsQLv4) questionnaire will be used to estimate scores that reflect the domains of physical functioning, emotional functioning, social functioning, and school functioning.

    A quality of life score will be calculated on a scale from 0-100. Higher scores = Better HRQOL.

  4. Fatigue

    Time frame: Baseline

    The multidimensional Fatigue scale (PedsQLv3 Fatigue) questionnaire will be used to estimate scores that reflect the domains of general fatigue, sleep/rest fatigue and cognitive fatigue.

    A Fatigue HRQOL score will be calculated on a scale from 0-100. Higher scores = Better HRQOL and fewer problems or symptoms

  5. Mental Health

    Time frame: Baseline

    The Revised Child Anxiety and Depression Scale (RCADS) will be used to estimate scores related to the following subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder).

    Each subscale will be calculated on a scale ranging from 0-18 and 0-30. From this t-scores can be calculated.

    Low severity: T-score below 65 Medium severity: T-score between 65-70 High severity: T-score above 70

  6. Strengths and Difficulties

    Time frame: Baseline

    The Strength and Difficulties Questionnaire (SDQ) will be used to estimate scores related to the following subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, prosocial behaviour.

    A Total difficulties score will be calculated on a scale from 0-40. Higher scores = more difficulties.

  7. Qualitative exploration of experiences, attitudes, and preferences

    Time frame: within 1-2months after primary outcomes have been completed

    Semi structured interviews with participants and families will be used to to gain deeper insights into patient experiences, attitudes, preferences, and future direction

Study contacts

Contact information is provided by the study sponsor or research team.

Pelagia Koufaki, PhD

CONTACT

[email protected]

+441314740000

Silene ten Seldam

CONTACT

[email protected]

+447341596914

Sponsors and collaborators

Lead sponsor

Queen Margaret University

Other

Registry information

Official study title

Evaluation of Physical Activity Behaviours, and Psychosocial Health Outcomes in Children and Young People with Chronic Kidney Disease

Acronym: PA-QOL-CKD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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