Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922970
Status:
UNKNOWN
Last Update Posted:
2021-06-23
First Post:
2021-06-04
Brief Title:
Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPS
Brief Summary:
Today the overall survival of childhood cancers has increased to above 85 This increase is partially caused by treatment with bone marrow transplantation A bone marrow transplantation is an efficient treatment against high-risk leukemia as well as other life-threatening immunological and hematological diseases However it is unfortunately also related to the risk of developing a long series of late effects during early adulthood such as low muscle mass cardiovascular disease and diabetes Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population
In the group of survivors after bone marrow transplantation the cause for these late effects is not fully understood as the same close association to lifestyle factors as seen in the general population is not present in this group Multiple studies have examined the possible causes and it have been shown that certain elements of a bone marrow transplantation ie total body irradiation are associated with the risk of developing late effects As the cause is not fully understood it is not known whether the treatment and preventive strategies that would be applied in the general population for these conditions are effective in this group
Therefore in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood
The investigators will invite a group of persons transplanted during childhood as well as an age- and sex-matched control group to participate in the study Both groups will go through a 16-week strength training intervention and a thorough health examination before and after the intervention to assess metabolic status and body composition
If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons treated with bone marrow transplantation during childhood it will support the implementation of structured training programs in the follow-up of these patients Thereby hopefully contributing to an increased quality of life as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood
In the group of survivors after bone marrow transplantation the cause for these late effects is not fully understood as the same close association to lifestyle factors as seen in the general population is not present in this group Multiple studies have examined the possible causes and it have been shown that certain elements of a bone marrow transplantation ie total body irradiation are associated with the risk of developing late effects As the cause is not fully understood it is not known whether the treatment and preventive strategies that would be applied in the general population for these conditions are effective in this group
Therefore in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood
The investigators will invite a group of persons transplanted during childhood as well as an age- and sex-matched control group to participate in the study Both groups will go through a 16-week strength training intervention and a thorough health examination before and after the intervention to assess metabolic status and body composition
If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons treated with bone marrow transplantation during childhood it will support the implementation of structured training programs in the follow-up of these patients Thereby hopefully contributing to an increased quality of life as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None