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Набор скоро начнётся NCT06677021

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

Без фазы С лечением Chronic Kidney Disease Stages 3-5

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Exercise.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Disease Stages 3-5. Базовые параметры: 6 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Exercise
    Physical activity promotion and engagement

Первичные конечные точки

  • Physical Activity: cardiorespiratory fitness [Срок оценки: Baseline]
  • Physical Activity: forearm strength [Срок оценки: Baseline]
  • Physical Activity: muscular endurance [Срок оценки: Baseline]
  • Accelerometer [Срок оценки: Baseline]
Вторичные конечные точки (7)
  • Frequency of physical activity [Срок оценки: Baseline]
  • Frequency of physical activity [Срок оценки: Baseline]
  • Quality of Life [Срок оценки: Baseline]
  • Fatigue [Срок оценки: Baseline]
  • Mental Health [Срок оценки: Baseline]
  • Strengths and Difficulties [Срок оценки: Baseline]
  • Qualitative exploration of experiences, attitudes, and preferences [Срок оценки: within 1-2months after primary outcomes have been completed]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • Glasgow Royal Hospital for Children — Glasgow

Идентификаторы

NCT: NCT06677021 · BUR 23-23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗