Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Changes in cross sectional area of m. quadricpes femoris.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Illness or physical handicap making it impossible to participate in the training intervention
- •Pregnancy
- •Not Danish or English speaking
- •Already performing regular structured physical training
- •Strict vegan or vegetarian diet
- •Illness or ongoing treatment that hinders study examinations
研究组 & 干预措施
Strength training
In this arm participants will go through the "Strength training intervention".
干预措施: Strength training (Other)
结局指标
主要结局
Changes in cross sectional area of m. quadricpes femoris.
时间窗: 1 week post intervention
Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
次要结局
- Urine sample - microalbuminurea(1 week post intervention)
- Changes in components of the Metabolic Syndrome: Waist circumference(1 week post intervention)
- Changes in components of the Metabolic Syndrome: HDL-cholesterol(1 week post intervention)
- Changes in components of the Metabolic Syndrome: Blood pressure(1 week post intervention)
- Hip circumference(1 week post intervention)
- Handgrip strength(1 week post intervention)
- Muscle performance: Sit-to-stand 30 sec.(1 week post intervention)
- Muscle performance: Sit-to-stand 60 sec.(1 week post intervention)
- Changes in components of the Metabolic Syndrome: Triglycerides(1 week post intervention)
- Cardiorespiratory fitness: 6 minute walk test(1 week post intervention)
- Changes in components of the Metabolic Syndrome: Fasting glucose(1 week post intervention)
- Muscle strength of quadriceps femoris(1 week post intervention)
- Muscle performance: Timed-up-and-go(1 week post intervention)
研究者
Klaus Gottlob Müller
Professor, Senior consultant, Doctor of Medical Science and ph.d.
Rigshospitalet, Denmark
