Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Integrative neuromuscular training (INT): Integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness. Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells). The INT group will receive usual standardized hospital care, including physiotherapy if needed.

Active control group: home-based training program: The active control group is offered a home-based training program consisting of combined aerobic, strength and stretching exercises. Further, they will receive monthly motivational consultations, as described below, concerning the training program. The use of the home-based training program will be monitored through exercise journals. The INT group will receive usual standardized hospital care, including physiotherapy if needed.

motivational counseling session: Each child and their parents will participate in a monthly 30-minute motivational counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale. The sessions are based on the principles in Self-Determination Theory that includes a spectrum of external and internal motivation factors for engaging in exercise. Each session will provide guidelines to increase the general activity levels and adjust the intervention according to the child's preferences and presence of symptoms.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Lower extremity isometric knee extension strength — 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 — 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 — 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 — 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.
• Lower extremity isometric knee extension strength — 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.

Trial sites (3)

Other trials for the same condition