Leukemia, AcuteNCT07046481
Physical Activity and Quality of Life in Childhood Cancersurvivors- a Long-term Follow-up
A study testing Physical activity in people with Leukemia, Acute and Brain Neoplasms, run by Region Skane.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Leukemia, Acute, Brain Neoplasms, Physical Fitness
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants diagnosed with Acute Lymphatic Leukemia or brain tumor 5- 10 years ago and available for follow-up at Lund University hospital.
Who cannot join
- Unable to walk with assistive devices, unable to communicate in the Swedish language
About this study
Official title: Functional Capacity, Physical Activity, Health-related Quality of Life and Fatigue in Young Cancer Survivors, 5-10 Years After Diagnosis
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:
Read more
- 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.
Read the detailed description
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.
Data collection from the cross sectional study will be used as baseline and supplemented with objective measurements of physical activity using an accelerometer before the start of the three-month intervention. Participants will be allowed to choose one or two physical activities. The activity can either be an organized sport activity or an everyday task such as walking the dog or cycling to school. To facilitate the selection of an activity that the participants are motivated to perform, a standardized survey is conducted. During the intervention, participants complete an exercise diary regarding intensity and frequency but also other experiences related to the activity. Motivational interviewing is used to support participants to make changes in their physical activity level. At the end of the intervention, levels of physical activity, sedentary behavior, physical functioning, health-related quality of life and fatigue and accelerometer measurements are compared to baseline measurements.
The total number of participants treated for brain tumor or leukemia and available for screening of inactivity over a three-year period corresponds to about 50-55 and 70 persons respectively. This means that in total there will be approximately 120 participants to invite to the screening study. Participants will be included until the total number of participants reaches 50. Those who are inactive will be recruited to the intervention study, where physical activity on prescription will be used in order to increase the participant's activity level. We estimate that twenty participants may be eligible for participating.
The study is descriptive in nature, so a power calculation cannot be performed.
Importance of the project The project will increase knowledge about young cancer survivors' functional capacity, physical activity level, health-related quality of life and prevalence of fatigue. In addition, the need for rehabilitative interventions will be identified, knowledge will be deepened on how physical activity can be promoted for young cancer survivors and how this can affect the individual's future functional capacity and quality of life.
- Conditions
- Leukemia, Acute, Brain Neoplasms, Physical Fitness, Quality of Life, Fatigue
- Being tested
- Physical activity
- Keywords
- physical activity, physical function, rehabilitation, inactivity, pediatric
- Medical subject headings
- Leukemia, Brain Neoplasms, Fatigue, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
One or two physical activities according to the participant´s preferences will be selected and prescribed and specified for frequence and intensity. The selected activity/-ies could be of any type, as long as they increase the heart rate. The activity/-ies should be performed regularly during 12 weeks, A training diary will be used to monitor and register the activities.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity on prescription | Experimental | World Health Organization recommends that children should engage in moderate to vigorous physical activity for at least 60 minutes a day. Participants who in the cross-sectional study are found not to fulfill the WHO recommendation on physical activity, will be recruited to the study where physical activity will be prescribed and performed according to the preferences of the participant.
Pre and post intervention physical activity, physical function, health related quality of life and fatigue will be assessed using standardized measures. Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruiniks Oseretsky test of motor proficiency
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.
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Secondary outcomes (7)
6 minut- walk test
The test is a submaximal excercise test used to assess aerobic capacity and endurance. The distance covered over a 6 minutes is used as the outcome by which to compare changes in performance capacity. The patient is instructed to continoiusly walk in a self-selected speed between two cones 30 m apart during 6 minutes. The patient is monitored for heart rate and oxygen saturation during the test and will be asked to assess level of excersion using the Borg Breathlessness scale.
The longer distance walked the better result.
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Grippit
Isometric grip strength is measured with the Grippit instrument, a electronic device used clinically that registers the grip force (N) generated by the muscles. Grippit consists of an elliptical handle, 12.5 cm in circumference, an electronic unit and an adapter for connection to electricity. The grip handle and a forearm support are fixed on a board, which enables the test position to be standardised. Higher force imply better grip strength.
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure is an outcome measure designed to capture a client's self-perception of performance in everyday living, over time. The COPM measures performance and satisfaction in self-care, productivity and leisure from the client's perspective and is rated from 1- 10 where a higher score imply that the client is more satisfied with performance with the specifified activity.
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Pediatric Quality of Life
The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Following dimensions are assessed:
Physical Functioning , Emotional Functioning , Social Functioning , School Functioning. Results are presented in Summary Scores; Total Scale Score, Physical Health Summary Score and Psychosocial Health Summary Score. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Pediatric Quality of Life Multifatigue scale
The PedsQL™ Multidimensional Fatigue Scale is a specific module of the PedsQL™ and was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. The module includes 18 items to be scored between 0-4, result may vary between 0-71 where a higher scores imply less fatigue.
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
International physical activity questionnaire
The International Physical Activity Questionnaire (IPAQ) can be used to obtain comparable estimates of physical activity. It was designed for physical activity surveillance and can be used with care in other contexts. Standardized assessment to survey the patients self assessed level of activity and inactivity during the last 7 days.
The IPAQ result in the amount of minutes of diffrerent levels of activity, the more minutes the patient is active in higher levels of activity the better.
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Accelerometer
The patient will wear a device to measure and record movement during seven consequtive days. Information on the amount, frequency and duration of physical activity will be collected and analyzed using a computer soft-ware by the researchers. Result will be presented in minutes at different levels of activity, the higher amount of minutes in higher levels of activity the more active.
Measured: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Why it stopped: Registration was withdrawn from clinicaltrials.gov as the ISRCTN registry was found to be more suitable for our study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Leukemia, AcuteStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasiblity study of the intervention Physical Activity on Prescription. Participants who are inactive according to the WHO recommendations, will be recruited to the study. Pre and post intervention assessment will be compared and participant's notes in a personal activity diary will be analyzed.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Brogårdh, Prof, Study director, Department of health Sciences, Medical faculty, Lund University. Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046481
- Sponsor's protocol ID
- 2024-1162 SUS S&D
- Other IDs
- 2023-06785-01, 2023
- Status last verified
- Jun 2025
- First submitted
- 8 Dec 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD that underlie results in the publication
Publications
Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
PubMed 16925881Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PubMed 11932914Lauruschkus K, Hallstrom I, Westbom L, Tornberg A, Nordmark E. Participation in physical activities for children with cerebral palsy: feasibility and effectiveness of physical activity on prescription. Arch Physiother. 2017 Nov 28;7:13. doi: 10.1186/s40945-017-0041-9. eCollection 2017.
PubMed 29340207Dinas PC, Koutedakis Y, Flouris AD. Effects of exercise and physical activity on depression. Ir J Med Sci. 2011 Jun;180(2):319-25. doi: 10.1007/s11845-010-0633-9. Epub 2010 Nov 14.
PubMed 21076975Slater ME, Steinberger J, Ross JA, Kelly AS, Chow EJ, Koves IH, Hoffmeister P, Sinaiko AR, Petryk A, Moran A, Lee J, Chow LS, Baker KS. Physical Activity, Fitness, and Cardiometabolic Risk Factors in Adult Survivors of Childhood Cancer with a History of Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2015 Jul;21(7):1278-83. doi: 10.1016/j.bbmt.2015.04.007. Epub 2015 Apr 10.
PubMed 25865649Han JW, Kim HS, Hahn SM, Jin SL, Shin YJ, Kim SH, Lee YS, Lee J, Lyu CJ. Poor bone health at the end of puberty in childhood cancer survivors. Pediatr Blood Cancer. 2015 Oct;62(10):1838-43. doi: 10.1002/pbc.25581. Epub 2015 May 13.
PubMed 25970742Landier W, Armenian S, Bhatia S. Late effects of childhood cancer and its treatment. Pediatr Clin North Am. 2015 Feb;62(1):275-300. doi: 10.1016/j.pcl.2014.09.017. Epub 2014 Oct 18.
PubMed 25435123Moody K, Meyer M, Mancuso CA, Charlson M, Robbins L. Exploring concerns of children with cancer. Support Care Cancer. 2006 Sep;14(9):960-6. doi: 10.1007/s00520-006-0024-y. Epub 2006 Apr 26.
PubMed 16639553Cox CL, Montgomery M, Oeffinger KC, Leisenring W, Zeltzer L, Whitton JA, Mertens AC, Hudson MM, Robison LL. Promoting physical activity in childhood cancer survivors: results from the Childhood Cancer Survivor Study. Cancer. 2009 Feb 1;115(3):642-54. doi: 10.1002/cncr.24043.
PubMed 19117349Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209.
PubMed 19224548
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Capacity, Physical Activity, Health-related Quality of Life and Fatigue in Young Cancer Survivors, 5-10 Years After Diagnosis
- ClinicalTrials.gov ID
- NCT07046481
- Acronym / sponsor ID
- 2024-1162 SUS S&D
- Conditions
- Leukemia, Acute, Brain Neoplasms, Physical Fitness, Quality of Life, Fatigue
- Keywords
- physical activity, physical function, rehabilitation, inactivity, pediatric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Registration was withdrawn from clinicaltrials.gov as the ISRCTN registry was found to be more suitable for our study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 1 Jul 2025 (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.
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.
Detailed description
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.
Data collection from the cross sectional study will be used as baseline and supplemented with objective measurements of physical activity using an accelerometer before the start of the three-month intervention. Participants will be allowed to choose one or two physical activities. The activity can either be an organized sport activity or an everyday task such as walking the dog or cycling to school. To facilitate the selection of an activity that the participants are motivated to perform, a standardized survey is conducted. During the intervention, participants complete an exercise diary regarding intensity and frequency but also other experiences related to the activity. Motivational interviewing is used to support participants to make changes in their physical activity level. At the end of the intervention, levels of physical activity, sedentary behavior, physical functioning, health-related quality of life and fatigue and accelerometer measurements are compared to baseline measurements.
The total number of participants treated for brain tumor or leukemia and available for screening of inactivity over a three-year period corresponds to about 50-55 and 70 persons respectively. This means that in total there will be approximately 120 participants to invite to the screening study. Participants will be included until the total number of participants reaches 50. Those who are inactive will be recruited to the intervention study, where physical activity on prescription will be used in order to increase the participant's activity level. We estimate that twenty participants may be eligible for participating.
The study is descriptive in nature, so a power calculation cannot be performed.
Importance of the project The project will increase knowledge about young cancer survivors' functional capacity, physical activity level, health-related quality of life and prevalence of fatigue. In addition, the need for rehabilitative interventions will be identified, knowledge will be deepened on how physical activity can be promoted for young cancer survivors and how this can affect the individual's future functional capacity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasiblity study of the intervention Physical Activity on Prescription. Participants who are inactive according to the WHO recommendations, will be recruited to the study. Pre and post intervention assessment will be compared and participant's notes in a personal activity diary will be analyzed.
| Arm | Type | Receives |
|---|---|---|
| Physical activity on prescription | Experimental | Other: Physical activityWorld Health Organization recommends that children should engage in moderate to vigorous physical activity for at least 60 minutes a day. Participants who in the cross-sectional study are found not to fulfill the WHO recommendation on physical activity, will be recruited to the study where physical activity will be prescribed and performed according to the preferences of the participant. Pre and post intervention physical activity, physical function, health related quality of life and fatigue will be assessed using standardized measures. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants diagnosed with Acute Lymphatic Leukemia or brain tumor 5- 10 years ago and available for follow-up at Lund University hospital.
Key exclusion criteria (1 listed)
- Unable to walk with assistive devices, unable to communicate in the Swedish language
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 |
|---|---|---|
| Physical activityOne or two physical activities according to the participant´s preferences will be selected and prescribed and specified for frequence and intensity. The selected activity/-ies could be of any type, as long as they increase the heart rate. The activity/-ies should be performed regularly during 12 weeks, A training diary will be used to monitor and register the activities. | Other | Physical activity on prescription |
Primary outcome
Bruiniks Oseretsky test of motor proficiency
Time frame: 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.
7 secondary outcomes
6 minut- walk test
Time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Grippit
Time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Canadian Occupational Performance Measure
Time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Pediatric Quality of Life
Time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Pediatric Quality of Life Multifatigue scale
Time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
International physical activity questionnaire
Time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Accelerometer
Time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Results publication: PubMed 16925881Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
- Results publication: PubMed 11932914Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Results publication: PubMed 29340207Lauruschkus K, Hallstrom I, Westbom L, Tornberg A, Nordmark E. Participation in physical activities for children with cerebral palsy: feasibility and effectiveness of physical activity on prescription. Arch Physiother. 2017 Nov 28;7:13. doi: 10.1186/s40945-017-0041-9. eCollection 2017.
- Results publication: PubMed 21076975Dinas PC, Koutedakis Y, Flouris AD. Effects of exercise and physical activity on depression. Ir J Med Sci. 2011 Jun;180(2):319-25. doi: 10.1007/s11845-010-0633-9. Epub 2010 Nov 14.
- Results publication: PubMed 25865649Slater ME, Steinberger J, Ross JA, Kelly AS, Chow EJ, Koves IH, Hoffmeister P, Sinaiko AR, Petryk A, Moran A, Lee J, Chow LS, Baker KS. Physical Activity, Fitness, and Cardiometabolic Risk Factors in Adult Survivors of Childhood Cancer with a History of Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2015 Jul;21(7):1278-83. doi: 10.1016/j.bbmt.2015.04.007. Epub 2015 Apr 10.
- Results publication: PubMed 25970742Han JW, Kim HS, Hahn SM, Jin SL, Shin YJ, Kim SH, Lee YS, Lee J, Lyu CJ. Poor bone health at the end of puberty in childhood cancer survivors. Pediatr Blood Cancer. 2015 Oct;62(10):1838-43. doi: 10.1002/pbc.25581. Epub 2015 May 13.
- Results publication: PubMed 25435123Landier W, Armenian S, Bhatia S. Late effects of childhood cancer and its treatment. Pediatr Clin North Am. 2015 Feb;62(1):275-300. doi: 10.1016/j.pcl.2014.09.017. Epub 2014 Oct 18.
- Results publication: PubMed 16639553Moody K, Meyer M, Mancuso CA, Charlson M, Robbins L. Exploring concerns of children with cancer. Support Care Cancer. 2006 Sep;14(9):960-6. doi: 10.1007/s00520-006-0024-y. Epub 2006 Apr 26.
- Results publication: PubMed 19117349Cox CL, Montgomery M, Oeffinger KC, Leisenring W, Zeltzer L, Whitton JA, Mertens AC, Hudson MM, Robison LL. Promoting physical activity in childhood cancer survivors: results from the Childhood Cancer Survivor Study. Cancer. 2009 Feb 1;115(3):642-54. doi: 10.1002/cncr.24043.
- Results publication: PubMed 19224548Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209.
- World Health Organization's guidelines on physical activity and sedentary behaviour.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All de-identified IPD that underlie results in the publication
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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. This study is not recruiting at the moment.
Christina Brogårdh, Prof study director
Department of health Sciences, Medical faculty, Lund University. Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Leukemia, Acute and Brain Neoplasms, run by Region Skane.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruiniks Oseretsky test of motor proficiency (time frame: Assessments will be performed prior to the 12 week-intervention and directly after finishing the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07046481, which also lists 10 linked publications.
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 1 Jul 2025.