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

NCT06677021 | Not Yet Recruiting

• 1 other identifier: BUR 23-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Stages 3-5

Keywords

Children and Young People; Chronic Kidney Disease; Physical activity; Psychosocial outcomes; Quality of life; Adolescents; Children; Exercise; Mental Health

Outcome Measures

Primary Outcomes (4)

• Physical Activity: cardiorespiratory fitness

  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

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

  Baseline

• Physical Activity: muscular endurance

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

  Baseline

• Accelerometer

  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 Outcomes (7)

• Frequency of physical activity

  Baseline

• Frequency of physical activity

  Baseline

• Quality of Life

  Baseline

• Fatigue

  Baseline

• Mental Health

  Baseline

Study Arms (1)

Physcial Activity Exercises

OTHER

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Physical activity promotion and engagement

Also known as: Quality of life

Physcial Activity Exercises

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• CYP of school age between 6 and 18 years
• Living and receiving care in Scotland for CKD
• no clinical contradictions to physical function assessments

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Margaret University: lead

Study Sites (1)

Glasgow Royal Hospital for Children

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity; Psychological Well-Being

Interventions

Exercise; Quality of Life

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Silene ten Seldam

CONTACT

+447341596914; silenetenseldam@yahoo.co.uk

Pelagia Koufaki, PhD

CONTACT

+441314740000; pkoufaki@qmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Exercise Physiology and Rehabilitation Sciences

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 6, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)