Chronic Kidney Disease Stages 3-5PA-QOL-CKDNCT06677021
Understanding Physical Activity and Quality of Life in Children and Young People with Chronic Kidney Disease
A study testing Exercise in people with Chronic Kidney Disease Stages 3-5, run by Queen Margaret University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Chronic Kidney Disease Stages 3-5
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CYP of school age between 6 and 18 years
- Living and receiving care in Scotland for CKD
- no clinical contradictions to physical function assessments
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Glasgow Royal Hospital for Children
Glasgow
Reynolds
About this study
Official title: 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.
Read the 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.
- Phase 1 consists of a battery of in-person physical functioning tests.
- Phase 2 consists of an online survey of validated questionnaires.
- 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
- Chronic Kidney Disease Stages 3-5
- Being tested
- Exercise
- Keywords
- Children and Young People, Chronic Kidney Disease, Physical activity, Psychosocial outcomes, Quality of life, Adolescents, Children, Exercise, Mental Health
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Quality of life
Physical activity promotion and engagement
| Study group | Role | What they receive |
|---|---|---|
| Physcial Activity Exercises | Other | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Physical Activity: forearm strength
Handgrip test - This test assesses static forearm strength using a handheld dynamometer.
Measured: Baseline
Physical Activity: muscular endurance
Sit-up test - This test will assess muscular endurance, particularly abdominal strength (dynamic trunk strength).
Measured: 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.
Measured: Baseline
Secondary outcomes (7)
Frequency of physical activity
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.
Measured: Baseline
Frequency of physical activity
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.
Measured: Baseline
Quality of Life
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.
Measured: Baseline
Fatigue
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
Measured: Baseline
Mental Health
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
Measured: Baseline
Strengths and Difficulties
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.
Measured: Baseline
Qualitative exploration of experiences, attitudes, and preferences
Semi structured interviews with participants and families will be used to to gain deeper insights into patient experiences, attitudes, preferences, and future direction
Measured: within 1-2months after primary outcomes have been completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stages 3-5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelagia Koufaki, PhD, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677021
- Sponsor's protocol ID
- BUR 23-23
- Acronym
- PA-QOL-CKD
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan yet
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Activity Behaviours, and Psychosocial Health Outcomes in Children and Young People with Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06677021
- Acronym / sponsor ID
- PA-QOL-CKD / BUR 23-23
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Phase 1 consists of a battery of in-person physical functioning tests.
- Phase 2 consists of an online survey of validated questionnaires.
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physcial Activity Exercises | Other | Behavioral: Exercise |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- CYP of school age between 6 and 18 years
- Living and receiving care in Scotland for CKD
- no clinical contradictions to physical function assessments
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Quality of lifePhysical activity promotion and engagement | Behavioural | Physcial Activity Exercises |
Primary outcome
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.
7 secondary outcomes
Frequency of physical activity
Time frame: Baseline
Frequency of physical activity
Time frame: Baseline
Quality of Life
Time frame: Baseline
Fatigue
Time frame: Baseline
Mental Health
Time frame: Baseline
Strengths and Difficulties
Time frame: Baseline
Qualitative exploration of experiences, attitudes, and preferences
Time frame: within 1-2months after primary outcomes have been completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No. No Plan yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chronic Kidney Disease Stages 3-5, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silene ten Seldam (+447341596914, silenetenseldam@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity: cardiorespiratory fitness (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.