Cardiovascular Diseases, Late Effect, Metabolic Syndrome, Stem Cell Transplant
Conditions
Keywords
Strength training, Resistance training
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.
Interventions
OTHERStrength training
The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months.
Sponsors
Rigshospitalet, Denmark
Bispebjerg Hospital
Danish Child Cancer Foundation
University of Copenhagen
The Danish Cancer Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cross sectional area of m. quadricpes femoris. | 1 week pre intervention | Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in components of the Metabolic Syndrome: Waist circumference | 1 week pre intervention | Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled. |
| Changes in components of the Metabolic Syndrome: Triglycerides | 1 week pre intervention | Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled. |
| Changes in components of the Metabolic Syndrome: HDL-cholesterol | 1 week pre intervention | Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled. |
| Changes in components of the Metabolic Syndrome: Fasting glucose | 1 week pre intervention | Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled. |
| Changes in components of the Metabolic Syndrome: Blood pressure | 1 week pre intervention | Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled. |
| Hip circumference | 1 week pre intervention | Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm. |
| Urine sample - microalbuminurea | 1 week pre intervention | A urine sample for analyses of microalbuminurea in mg/L. |
| Muscle strength of quadriceps femoris | 1 week pre intervention | Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer |
| Handgrip strength | 1 week pre intervention | Handgrip strength measured with handheld Dynamometer |
| Muscle performance: Timed-up-and-go | 1 week pre intervention | Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees. From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome. The lowest score of three consecutive tries will be used in the analysis. |
| Muscle performance: Sit-to-stand 30 sec. | 1 week pre intervention | Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome. |
| Muscle performance: Sit-to-stand 60 sec. | 1 week pre intervention | Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome. |
| Cardiorespiratory fitness: 6 minute walk test | 1 week pre intervention | 6 min. walk test: The participant walks as far as possible on a 15 m lane in 6 min. Distance in meters is the outcome. |
Countries
Denmark
Outcome results
None listed