跳至主要内容
临床试验/NCT07046481
NCT07046481撤回不适用

Functional Capacity, Physical Activity, Health-related Quality of Life and Fatigue in Young Cancer Survivors, 5-10 Years After Diagnosis

Region Skane0 个研究点开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Region Skane
主要终点
Bruiniks Oseretsky test of motor proficiency

研究概览

简要总结

The project intends to study physical functional capacity and degree of physical activity health related quality of life and fatigue. Also, we aim to study if the Physical Activity on Prescription (PAP) intervention is a useful method among physically inactive childhood cancer survivors to increase level of activity.

The questions the study aim to answer:

  • What is the physical functional capacity, degree of physical activity, health related quality of life and fatigue among childhood cancer survivors 5- 10 yars after dignosis?
  • Is the Physical Activity on Prescription intervention feasible for physically inactive childhood cancer survivors and what effect do they experience in terms of physical functioning, physical activity, sedentary behavior, fatigue and health-related quality of life?

Participants aged 5-17 years who have been treated for leukemia or brain tumor will be invited to participate. Physical functional capacity and degree of physical activity are assessed with standardized assessment instruments by a physiotherapist. Prior to the visit, participants are also asked to complete questionnaires on HRQoL and fatigue.

Participants identified as physically inactive are offered to participate in a PAP intervention. Functional ability scores from previous studies are used as a baseline and are supplemented with objective measurements of physical activity and followed up after the intervention.

详细描述

The challenges of childhood cancer survivors to incorporate exercise and physical activity into their lives need to be systematically studied so that health care professionals can provide adequate support during and after treatment. It is therefore of great clinical relevance to gather knowledge on how physiotherapists can design and support regular physical activity and exercise for childhood cancer survivors. The project intends to study the feasibility of the PAP intervention on physical functioning, physical activity, sedentary behavior, fatigue and health-related quality of life among physically inactive children and adolescents who have survived childhood cancer, and whether it is a suitable method for these patient groups.

Methodology Participants must have been treated for brain tumor or acute lymphoblastic leukemia and be eligible for follow-up at the Pediatric Department at Skåne University Hospital before the age of 18.

Physical functioning, level of physical activity/sedentary behavior, health-related quality of life and fatigue are studied in a descriptive cross-sectional study. All children and adolescents aged 5-17 years treated for leukemia or brain tumor and scheduled for their usual follow-up 5-10 years after diagnosis identified using registers from (Swedish national registry of long-term follow-up in childhood cancer) SALUB are invited to participate, the sample is consecutive over a three-year period. Assessments of physical functioning and physical activity are performed by a physiotherapist in conjunction with a visit to the pediatric clinic. Prior to the visit, participants will complete the questionnaires on health related quality of life and fatigue.

Participants identified as physically inactive according to the WHO guidelines will be recruited to the intervention study where the PAP will be offered.

The intervention study explores the feasibility of benefits and effects on physical functioning, physical activity/ sedentary behavior, fatigue and health related quality of life after a PAP intervention in physically inactive childhood cancer survivors in a feasibility study. Participants identified as physically inactive in the initial study are invited to participate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants diagnosed with Acute Lymphatic Leukemia or brain tumor 5- 10 years ago and available for follow-up at Lund University hospital.

排除标准

  • Unable to walk with assistive devices, unable to communicate in the Swedish language

结局指标

主要结局

Bruiniks Oseretsky test of motor proficiency

时间窗: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate. The BOT-2 provides several types of derived scores that assists in interpreting performance. Scale scores (mean = 15, standard deviation = 5), confidence intervals, age equivalents, and descriptive categories are used to describe subtest performance. Standard scores (mean = 50, standard deviation = 10), confidence intervals, percentile ranks, and descriptive categories are used to describe composite and Short Form performance.

Bruiniks Oseretsky test of motor proficiency

时间窗: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.

BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate. The BOT-2 provides several types of derived scores that assists in interpreting performance. Scale scores (mean = 15, standard deviation = 5), confidence intervals, age equivalents, and descriptive categories are used to describe subtest performance. Standard scores (mean = 50, standard deviation = 10), confidence intervals, percentile ranks, and descriptive categories are used to describe composite and Short Form performance.

次要结局

  • 6 minut- walk test(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Grippit(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Pediatric Quality of Life(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Accelerometer(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Canadian Occupational Performance Measure(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Pediatric Quality of Life Multifatigue scale(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • International physical activity questionnaire(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • 6 minut- walk test(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Grippit(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Canadian Occupational Performance Measure(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Pediatric Quality of Life(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)
  • Accelerometer(Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

相似试验