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Clinical Trials/NCT06677021
NCT06677021
Not yet recruiting
Not Applicable

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

Queen Margaret University1 site in 1 country20 target enrollmentDecember 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease Stages 3-5
Sponsor
Queen Margaret University
Enrollment
20
Locations
1
Primary Endpoint
Physical Activity: cardiorespiratory fitness
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2024
End Date
September 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pelagia Koufaki, PhD

Reader in Exercise Physiology and Rehabilitation Sciences

Queen Margaret University

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.

Outcomes

Primary Outcomes

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.

Physical Activity: forearm strength

Time Frame: Baseline

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

Physical Activity: muscular endurance

Time Frame: Baseline

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

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

  • Frequency of physical activity(Baseline)
  • Quality of Life(Baseline)
  • Fatigue(Baseline)
  • Mental Health(Baseline)
  • Strengths and Difficulties(Baseline)
  • Qualitative exploration of experiences, attitudes, and preferences(within 1-2months after primary outcomes have been completed)

Study Sites (1)

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