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

NCT ID: NCT06677021

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Stages 3-5

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Physcial Activity Exercises

Group Type OTHER

Exercise

Intervention Type BEHAVIORAL

Physical activity promotion and engagement

Interventions

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Exercise

Physical activity promotion and engagement

Intervention Type BEHAVIORAL

Other Intervention Names

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Quality of life

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Margaret University

OTHER

Sponsor Role lead

Responsible Party

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Pelagia Koufaki, PhD

Reader in Exercise Physiology and Rehabilitation Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Glasgow Royal Hospital for Children

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Silene ten Seldam

Role: CONTACT

+447341596914

Pelagia Koufaki, PhD

Role: CONTACT

+441314740000

Facility Contacts

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Reynolds

Role: primary

Other Identifiers

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BUR 23-23

Identifier Type: -

Identifier Source: org_study_id

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