Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer- a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 3
- 主要终点
- Lower extremity isometric knee extension strength
研究概览
简要总结
The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization, health-related quality of life and health behavior in children and adolescents with cancer. The increased insight derived from this study will impact the development of pediatric exercise oncology and be of high relevance to a broad group of children and adolescents with severe chronic illness.
The study is based on the overarching hypothesis, that structured integrative neuromuscular training initiated immediately after diagnosis will be effective in preventing deficits in neuromuscular function, limit long-term cardio-metabolic morbidity and found long-standing improvements in physical activity behavior.
To maintain adherence and motivation throughout a 6-month training intervention, weekly supervision of the training is needed. For this study, it is hypothesized that a supervised exercise intervention, in addition to a motivational counseling intervention and usual care, will improve muscle strength compared with unsupervised home-based training (active controls).
详细描述
Improved childhood cancer survival rates call for novel strategies to reduce acute and long-term physical complications of anti-cancer treatment.
Children with cancer have markedly impaired muscle strength, cardiorespiratory fitness, and physical function occurring few days after diagnosis - further declining because of anti-cancer treatment and physical inactivity during the treatment trajectory. Moreover, these impairments persist years after ended treatment. Further, the children become physically illiterate, which include a lack of confidence, competence and motivation to engage in physical activities. The combination of persistent physical complications and physical illiteracy predispose for metabolic- as well as musculoskeletal dysfunction that lead to severe medical conditions such as metabolic syndrome, diabetes and cardiovascular disease with reduced life-expectancy.
Studies indicate that structured exercise aimed to optimize both muscle and neuronal functions ('integrative neuromuscular training'), should be explored further to effectively counteract the impairment in physical function caused by childhood cancer and its treatment and found a more healthy lifestyle after ended treatment. This age-adjusted, strength-based exercise concept, based on games and play, is hypothesized to improve physical function in children and adolescents diagnosed with cancer.
The primary objective of this study is to investigate the effects of a 6-months integrative neuromuscular training intervention on knee extension strength in children and adolescents, ages 6-18 years, with cancer during anti-cancer treatment, compared with an active control group. Our secondary objectives are to investigate the effects of the intervention on markers of metabolic syndrome, hospitalized days, health-related quality of life, upper body muscle strength, cardiorespiratory fitness, physical function, physical activity behavior and body composition.
All outcomes, except hospitalized days, will be measured within 2 weeks of treatment initiation, 3-months after inclusion, after 6-months after inclusion, one month after ended treatment and 1 year after ended treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All malign and benign disorders treated with chemotherapy and/or irradiation
排除标准
- •Severe mental and/or physical disability, i.e. participants where all types of physical training and testing of physical function are contraindicated
- •terminal illness
- •unable to communicate in Danish
研究组 & 干预措施
Integrative neuromuscular training + motivational counseling + usual care
General and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility.
干预措施: Integrative neuromuscular training (INT) (Behavioral)
Integrative neuromuscular training + motivational counseling + usual care
General and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility.
干预措施: motivational counseling session (Behavioral)
Active control group + motivational counseling + usual care
home-based training program
干预措施: motivational counseling session (Behavioral)
Active control group + motivational counseling + usual care
home-based training program
干预措施: Active control group: home-based training program (Behavioral)
结局指标
主要结局
Lower extremity isometric knee extension strength
时间窗: 1 year after ended treatment
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
时间窗: Within 2 weeks of treatment initiation (baseline)
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
时间窗: 3-months after inclusion
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
时间窗: 6-months after inclusion (primary endpoint)
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
时间窗: 1 month after ended treatment
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
次要结局
- Hospitalized days(1 year after ended treatment)
- Body composition: Bone Mineral Density(1 year after end of treatment (primary endpoint).)
- Markers of metabolic syndrome: blood pressure (primary secondary outcome)(1 year after end of treatment (primary endpoint))
- Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol(primary secondary outcome)(1 month after ended treatment)
- Body composition: Body Fat(1 year after end of treatment (primary endpoint).)
- Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)(1 year after end of treatment (primary endpoint))
- Hand Grip strength(1 year after ended treatment)
- Six Minutes Walk Test(1 year after ended treatment)
- The timed Up-and-Go Test:(1 year after ended treatment)
- Body composition: Bone Mineral Content(1 year after end of treatment (primary endpoint).)
- Markers of metabolic syndrome: Waist circumference (primary secondary outcome)(1 year after end of treatment (primary endpoint))
- Markers of metabolic syndrome: triglycerides (primary secondary outcome)(1 year after end of treatment (primary endpoint))
- Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)(1 year after end of treatment (primary endpoint))
- Isometric Bench Press(1 year after ended treatment)
- Thirty Seconds and One-Minute Sit-to-stand(1 year after ended treatment)
- Body composition: Fat-Free Mass(1 year after end of treatment (primary endpoint).)
- The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:(1 year after ended treatment)
- Prevalence of metabolic syndrome(1 year after end of treatment (primary endpoint))
- Markers of metabolic syndrome: Waist circumference (primary secondary outcome)(within 2 weeks of treatment initiation)
- Markers of metabolic syndrome: triglycerides (primary secondary outcome)(within 2 weeks of treatment initiation)
- Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)(within 2 weeks of treatment initiation)
- Markers of metabolic syndrome: blood pressure (primary secondary outcome)(within 2 weeks of treatment initiation)
- Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)(within 2 weeks of treatment initiation)
- Markers of metabolic syndrome: Waist circumference (primary secondary outcome)(6 months after inclusion (before a treatment block))
- Markers of metabolic syndrome: triglycerides (primary secondary outcome)(6 months after inclusion (before a treatment block))
- Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)(6 months after inclusion (before a treatment block))
- Markers of metabolic syndrome: blood pressure (primary secondary outcome)(6 months after inclusion (before a treatment block))
- Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)(6 months after inclusion (before a treatment block))
- Markers of metabolic syndrome: Waist circumference (primary secondary outcome)(1 month after ended treatment)
- Markers of metabolic syndrome: triglycerides (primary secondary outcome)(1 month after ended treatment)
- Markers of metabolic syndrome: blood pressure (primary secondary outcome)(1 month after ended treatment)
- Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)(1 month after ended treatment)
- Isometric Bench Press(Within 2 weeks of treatment initiation (baseline))
- Hospitalized days(1month after ended treatment)
- Isometric Bench Press(3-months after inclusion)
- Body composition: Bone Mineral Content(within 2 weeks of treatment initiation)
- Isometric Bench Press(6-months after inclusion (primary endpoint))
- Isometric Bench Press(1 month after ended treatment)
- Hand Grip strength(Within 2 weeks of treatment initiation (baseline))
- Hand Grip strength(3-months after inclusion)
- Hand Grip strength(6-months after inclusion (primary endpoint))
- Hand Grip strength(1 month after ended treatment)
- Six Minutes Walk Test(Within 2 weeks of treatment initiation (baseline))
- Six Minutes Walk Test(3-months after inclusion)
- Six Minutes Walk Test(6-months after inclusion (primary endpoint))
- Six Minutes Walk Test(1 month after ended treatment)
- Thirty Seconds and One-Minute Sit-to-stand(Within 2 weeks of treatment initiation (baseline))
- Thirty Seconds and One-Minute Sit-to-stand(3-months after inclusion)
- Thirty Seconds and One-Minute Sit-to-stand(6-months after inclusion (primary endpoint))
- The timed Up-and-Go Test:(3-months after inclusion)
- Thirty Seconds and One-Minute Sit-to-stand(1 month after ended treatment)
- The timed Up-and-Go Test:(Within 2 weeks of treatment initiation (baseline))
- The timed Up-and-Go Test:(6-months after inclusion (primary endpoint))
- The timed Up-and-Go Test:(1 month after ended treatment)
- Hospitalized days(measured 6 months after inclusion (primary endpoint))
- Body composition: Bone Mineral Density(within 2 weeks of treatment initiation)
- Body composition: Body Fat(within 2 weeks of treatment initiation)
- Body composition: Fat-Free Mass(within 2 weeks of treatment initiation)
- Body composition: Bone Mineral Density(6 months after inclusion (before a treatment block))
- Body composition: Bone Mineral Content(6 months after inclusion (before a treatment block))
- Body composition: Body Fat(6 months after inclusion (before a treatment block))
- Body composition: Fat-Free Mass(6 months after inclusion (before a treatment block))
- Body composition: Bone Mineral Density(1 month after ended treatment.)
- Body composition: Bone Mineral Content(1 month after ended treatment.)
- Body composition: Body Fat(1 month after ended treatment.)
- Body composition: Fat-Free Mass(1 month after ended treatment.)
- The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:(Within 2 weeks of treatment initiation)
- The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:(6-months after inclusion.)
- The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:(1 month after ended treatment)
- Prevalence of metabolic syndrome(within 2 weeks of treatment initiation.)
- Prevalence of metabolic syndrome(6 months after inclusion (before a treatment block))
- Prevalence of metabolic syndrome(1 month after ended treatment.)
研究者
Hanne Baekgaard Larsen
Associate Professor
Rigshospitalet, Denmark