Physical Activity, Sports, and Health in Adults With Intellectual Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change in body fat mass
研究概览
简要总结
Currently, there is a paucity of quality research within the field of health science with a focus on persons with intellectual disabilities, and especially how longer lasting periods of varied physical activity affects the target group. There is a lack of insight, in how persons with intellectual disabilities learns and retains movement skills. Thus, the research group behind this project will investigate the following research questions:
- Does 40 weeks of intense and varied sports and physical activities as an intervention lead to positive changes in health status for adults with intellectual disabilities?
- Can lasting effects be measured three and six months after the intervention?
- Does the intervention improve the motor competences for the participants?
- How does defined groups of adult persons with Down syndrome and Cerebral Palsy learn and retain a new motor skill?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Presence of an intellectual disability
排除标准
- •Participants under guardianship
- •Unable to give informed consent to participate on their own
结局指标
主要结局
Change in body fat mass
时间窗: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Body fat mass in kilograms
Change in cardiovascular fitness
时间窗: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Change in heart rate during the same absolute submaximal exercise intensity
Change in T-scores of the whole body
时间窗: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Whole body T-score. An arbitrary measure, describing the bone mineral density of the subjects relative to a reference value from 30 year old healthy persons.
Change in areal bone mineral density of the lumbar spine (L1-L4)
时间窗: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Areal bone mineral density in grams per square centimeter (g/cm2) of the lumbar spine (L1-L4)
Change in fat free mass
时间窗: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Fat free mass in kilograms
Change in T-scores of the lumbar spine (L1-L4)
时间窗: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Lumbar spine (L1-L4) T-score. An arbitrary measure, describing the bone mineral density of the subjects relative to a reference value from 30 year old healthy persons.
Change in lean mass
时间窗: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Lean body mass in kilograms
Change in areal bone mineral density of the whole body
时间窗: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Areal bone mineral density in grams per square centimeter (g/cm2) of the whole body
Change in Plasma bone turn-over marker (P1NP)
时间窗: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Procollagen type 1 N-terminal propeptide (P1NP), measured as μg/L
Change in body weight
时间窗: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Body weight in kilograms
Change in areal bone mineral density of the bilateral femur regions
时间窗: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Areal bone mineral density grams per square centimeter (g/cm2) of the bilateral femur regions
Change in plasma bone turn-over marker (CTX)
时间窗: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Carboxy-terminal collagen crosslinks (CTX), measured as μg/L
Plasma bone turn-over marker (Osteocalcin)
时间窗: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Osteocalcin, measured as μg/L
Change in T-scores of the bilateral femur regions
时间窗: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
T-scores of the bilateral femur regions. An arbitrary measure, describing the bone mineral density of the subjects relative to a reference value from 30 year old healthy persons.
次要结局
未报告次要终点
研究者
Jacob Wienecke
Principal Investigator, Associate Professor
University of Copenhagen