Clinical Trial Finder

Inclusion Criteria:

• - All malign and benign disorders treated with chemotherapy and/or irradiation.

Exclusion Criteria:

• - 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

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. The primary endpoint for the primary objective and secondary objectives, besides metabolic syndrome, are 6 months after treatment initiation. The primary endpoint for markers of metabolic syndrome will be 1 year after cessation of treatment. The INTERACT study is a national multicenter, two arm parallel group, randomized controlled superiority trial with 12 months follow-up after ended treatment, based in all national centers for pediatric oncology: University Hospital of Copenhagen (Rigshospitalet), Aarhus University Hospital and Odense University Hospital. The study will include 127 children aged 6-18 years with any type of cancer that will be randomized (2:2) to either the intervention group (integrative neuromuscular training + motivational-counseling sessions + usual care) or active control group (home-based training program + motivational-counseling sessions + usual care) and stratified by sex, pubertal stage and diagnosis as 1) treatment for extracranial solid tumors and CNS-tumors; 2) treatment for hematologic malignancy 3) stem cell transplantation, within each hospital. This intervention, 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. The integrative neuromuscular training group will in addition to usual care receive the intervention for six months. All participants are recommended to participate in a minimum of 2 training session per week the first 7 weeks, and a minimum of three session per week from week 8-24. During the intense phase of treatment (first six months of treatment), all participants indifferent of cancer type will receive combinations of treatment requiring either hospitalization or visits to the outpatient clinic at least once per week. The participants, therefore, receives supervised training at least once per week. All other training session is conducted as home-based training. If there are weeks, without any visits to the hospital or outpatient clinic, all training session will be conducted at home. In this case, the participants will receive a phone call from the intervention physiotherapist concerning questions, exercise choice and intensity of exercises. 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 active control group is, in addition to usual care, offered a home-based training program consisting of combined aerobic, strength and stretching exercises. Participants in both groups will receive 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. Both groups receive standardized hospital care, usual care, including physiotherapy if needed. Sample size: A difference of 10 % as a result of physical exercise is regarded as a clinically relevant change (1). Based on a mean 41.4 +/- 7.6

• (2) and a 10% increase, an alpha level of 0.05 and power of 80%, 106 children are needed.

Approximately, 60 children with cancer at the age of 6-18 years will be diagnosed pr. year at Copenhagen University Hospital, Rigshospitalet Aarhus University Hospital and Odense University Hospital. Assuming a 20 % dropout rate, a total of 2.2 years is needed to include the required number of children with cancer (n=127). A blinded statistician will randomize participants to either intervention or active control group using a computer-generated concealed allocation procedure, to secure a proportionate stratified random sample. Due to the nature of the intervention, neither participants, nor assessors, will be blinded to the allocation.

Arms

Experimental: 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.

Active Comparator: Active control group + motivational counseling + usual care

home-based training program

Interventions

Behavioral: - 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.

Behavioral: - 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.

Behavioral: - 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.