Clinical trial NCT04922970: Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.
Official title: Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stem Cell Transplant
Late Effect
Metabolic Syndrome
Cardiovascular Diseases
Keywords: Strength training
Resistance training
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: Danish Child Cancer Foundation
name: University of Copenhagen
name: The Danish Cancer Research Foundation
First posted: 2021-06-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The same interventon will be applied to two groups, a group of previously recipients of bone marrow transplantation, and a group of age- and sex-matched controls.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
* ≥ 18 years old

Exclusion Criteria:

* Illness or physical handicap making it impossible to participate in the training intervention
* Pregnancy
* Not Danish or English speaking
* Anemia
* Already performing regular structured physical training
* Strict vegan or vegetarian diet
* Illness or ongoing treatment that hinders study examinations

Primary outcomes:
measure: Changes in cross sectional area of m. quadricpes femoris.
timeFrame: 1 week pre intervention
measure: Changes in cross sectional area of m. quadricpes femoris.
timeFrame: 1 week post intervention
Secondary outcomes:
measure: Changes in components of the Metabolic Syndrome: Waist circumference
timeFrame: 1 week pre intervention
measure: Changes in components of the Metabolic Syndrome: Waist circumference
timeFrame: 1 week post intervention
measure: Changes in components of the Metabolic Syndrome: Triglycerides
timeFrame: 1 week pre intervention
measure: Changes in components of the Metabolic Syndrome: Triglycerides
timeFrame: 1 week post intervention
measure: Changes in components of the Metabolic Syndrome: HDL-cholesterol
timeFrame: 1 week pre intervention
measure: Changes in components of the Metabolic Syndrome: HDL-cholesterol
timeFrame: 1 week post intervention
measure: Changes in components of the Metabolic Syndrome: Fasting glucose
timeFrame: 1 week pre intervention
measure: Changes in components of the Metabolic Syndrome: Fasting glucose
timeFrame: 1 week post intervention
measure: Changes in components of the Metabolic Syndrome: Blood pressure
timeFrame: 1 week pre intervention
measure: Changes in components of the Metabolic Syndrome: Blood pressure
timeFrame: 1 week post intervention
measure: Hip circumference
timeFrame: 1 week pre intervention
measure: Hip circumference
timeFrame: 1 week post intervention
measure: Urine sample - microalbuminurea
timeFrame: 1 week pre intervention
measure: Urine sample - microalbuminurea
timeFrame: 1 week post intervention
measure: Muscle strength of quadriceps femoris
timeFrame: 1 week pre intervention
measure: Muscle strength of quadriceps femoris
timeFrame: 1 week post intervention
measure: Handgrip strength
timeFrame: 1 week pre intervention
measure: Handgrip strength
timeFrame: 1 week post intervention
measure: Muscle performance: Timed-up-and-go
timeFrame: 1 week pre intervention
measure: Muscle performance: Timed-up-and-go
timeFrame: 1 week post intervention
measure: Muscle performance: Sit-to-stand 30 sec.
timeFrame: 1 week pre intervention
measure: Muscle performance: Sit-to-stand 30 sec.
timeFrame: 1 week post intervention
measure: Muscle performance: Sit-to-stand 60 sec.
timeFrame: 1 week pre intervention
measure: Muscle performance: Sit-to-stand 60 sec.
timeFrame: 1 week post intervention
measure: Cardiorespiratory fitness: 6 minute walk test
timeFrame: 1 week pre intervention
measure: Cardiorespiratory fitness: 6 minute walk test
timeFrame: 1 week post intervention
Other outcomes:
measure: Histology of thigh muscle
timeFrame: 1 week pre intervention
measure: Histology of thigh muscle
timeFrame: 1 week post intervention
measure: Body composition: Intraabdominal visceral fat
timeFrame: 1 week pre intervention
measure: Body composition: Intraabdominal visceral fat
timeFrame: 1 week post intervention
measure: Body composition: Abdominal subcutaneous fat
timeFrame: 1 week pre intervention
measure: Body composition: Abdominal subcutaneous fat
timeFrame: 1 week post intervention
measure: Body composition: Hepatic fat
timeFrame: 1 week pre intervention
measure: Body composition: Hepatic fat
timeFrame: 1 week post intervention
measure: Body composition: Fat mass
timeFrame: 1 week pre intervention
measure: Body composition: Fat mass
timeFrame: 1 week post intervention
measure: Body composition: Fat free mass
timeFrame: 1 week pre intervention
measure: Body composition: Fat free mass
timeFrame: 1 week post intervention
measure: Body composition: Android-gynoid ratio
timeFrame: 1 week pre intervention
measure: Body composition: Android-gynoid ratio
timeFrame: 1 week post-intervention
measure: Body composition: Bone mineral density
timeFrame: 1 week pre intervention
measure: Body composition: Bone mineral density
timeFrame: 1 week post intervention
measure: Body mass index (BMI)
timeFrame: 1 week pre intervention
measure: Body mass index (BMI)
timeFrame: 1 week post intervention
measure: Total-cholesterol
timeFrame: 1 week pre intervention
measure: Total-cholesterol
timeFrame: 1 week post intervention
measure: LDL-cholesterol
timeFrame: 1 week pre intervention
measure: LDL-cholesterol
timeFrame: 1 week post intervention
measure: Adipokines: Adiponectin
timeFrame: 1 week pre intervention
measure: Adipokines: Adiponectin
timeFrame: 1 week post intervention
measure: Adipokines: Leptin
timeFrame: 1 week pre intervention
measure: Adipokines: Leptin
timeFrame: 1 week post intervention
measure: Growth factors
timeFrame: 1 week pre intervention
measure: Growth factors
timeFrame: 1 week post intervention
measure: Thyroid hormones
timeFrame: 1 week pre intervention
measure: Thyroid hormones
timeFrame: 1 week post intervention
measure: Sex hormones
timeFrame: 1 week pre intervention
measure: Sex hormones
timeFrame: 1 week post intervention
measure: Markers of inflammation
timeFrame: 1 week pre intervention
measure: Markers of inflammation
timeFrame: 1 week post intervention
measure: Oral glucose tolerance test: Glucose
timeFrame: 1 week pre intervention
measure: Oral glucose tolerance test: Glucose
timeFrame: 1 week post intervention
measure: Oral glucose tolerance test: Insulin
timeFrame: 1 week pre intervention
measure: Oral glucose tolerance test: Insulin
timeFrame: 1 week post intervention
measure: Oral glucose tolerance test: C-peptide
timeFrame: 1 week pre intervention
measure: Oral glucose tolerance test: C-peptide
timeFrame: 1 week post intervention
measure: Oral glucose tolerance test: Gut hormones
timeFrame: 1 week pre intervention
measure: Oral glucose tolerance test: Gut hormones
timeFrame: 1 week post intervention
measure: Oral glucose tolerance test: Bone remodeling markers
timeFrame: 1 week pre intervention
measure: Oral glucose tolerance test: Bone remodeling markers
timeFrame: 1 week post intervention
measure: Health related quality of life - SF36
timeFrame: 1 week pre intervention
measure: Health related quality of life - SF36
timeFrame: 1 week post intervention
measure: Accelerometry using actigraph
timeFrame: 1 week pre intervention
measure: Accelerometry using actigraph
timeFrame: 1 week post intervention
measure: Oral glucose tolerance test: Matsuda Index
timeFrame: 1 week pre intervention
measure: Oral glucose tolerance test: Matsuda Index
timeFrame: 1 week post intervention
measure: Oral glucose tolerance test: Insulinogenic Index
timeFrame: 1 week pre intervention
measure: Oral glucose tolerance test: Insulinogenic Index
timeFrame: 1 week post intervention
Locations:
Study officials:
References: