Understanding Physical Activity and Quality of Life in Children and Young People with Chronic Kidney Disease (PA-QOL-CKD)

November 6, 2024 updated by: Pelagia Koufaki, PhD, Queen Margaret University

Evaluation of Physical Activity Behaviours, and Psychosocial Health Outcomes 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • Glasgow Royal Hospital for Children
        • Contact:
          • Reynolds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physcial Activity Exercises
Behavioral: Exercise
Physical activity promotion and engagement
Other Names:
  • Quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
Physical Activity: forearm strength
Time Frame: Baseline
Handgrip test - This test assesses static forearm strength using a handheld dynamometer.
Baseline
Physical Activity: muscular endurance
Time Frame: Baseline
Sit-up test - This test will assess muscular endurance, particularly abdominal strength (dynamic trunk strength).
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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
Baseline
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
Baseline
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.
Baseline
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
within 1-2months after primary outcomes have been completed
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Margaret University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUR 23-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Plan yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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