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

Queen Margaret University

Status: Not yet enrolling

Conditions: Chronic Kidney Disease Stages 3-5

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06677021

BUR 23-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Physcial Activity Exercises

Other group

Treatment:

Behavioral: Exercise