Clinical trial NCT04706676: Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer
Official title: Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer- a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Leukemia
Neoplasms
Lymphoma
Solid Tumor
CNS Tumor
Keywords: Pediatric Exercise Oncology
Integrative Neuromuscular Training
Children and Adolescents
ResistanceTraining
Metabolic Syndrome
Physical Activity
Motivation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
First posted: 2021-01-13
Enrollment: 132
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower extremity isometric knee extension strength
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Lower extremity isometric knee extension strength
timeFrame: 3-months after inclusion
measure: Lower extremity isometric knee extension strength
timeFrame: 6-months after inclusion (primary endpoint)
measure: Lower extremity isometric knee extension strength
timeFrame: 1 month after ended treatment
measure: Lower extremity isometric knee extension strength
timeFrame: 1 year after ended treatment
Secondary outcomes:
measure: Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
timeFrame: within 2 weeks of treatment initiation
measure: Markers of metabolic syndrome: triglycerides (primary secondary outcome)
timeFrame: within 2 weeks of treatment initiation
measure: Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
timeFrame: within 2 weeks of treatment initiation
measure: Markers of metabolic syndrome: blood pressure (primary secondary outcome)
timeFrame: within 2 weeks of treatment initiation
measure: Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
timeFrame: within 2 weeks of treatment initiation
measure: Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
timeFrame: 6 months after inclusion (before a treatment block)
measure: Markers of metabolic syndrome: triglycerides (primary secondary outcome)
timeFrame: 6 months after inclusion (before a treatment block)
measure: Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
timeFrame: 6 months after inclusion (before a treatment block)
measure: Markers of metabolic syndrome: blood pressure (primary secondary outcome)
timeFrame: 6 months after inclusion (before a treatment block)
measure: Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
timeFrame: 6 months after inclusion (before a treatment block)
measure: Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
timeFrame: 1 month after ended treatment
measure: Markers of metabolic syndrome: triglycerides (primary secondary outcome)
timeFrame: 1 month after ended treatment
measure: Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol(primary secondary outcome)
timeFrame: 1 month after ended treatment
measure: Markers of metabolic syndrome: blood pressure (primary secondary outcome)
timeFrame: 1 month after ended treatment
measure: Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
timeFrame: 1 month after ended treatment
measure: Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Markers of metabolic syndrome: triglycerides (primary secondary outcome)
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Markers of metabolic syndrome: blood pressure (primary secondary outcome)
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Isometric Bench Press
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Isometric Bench Press
timeFrame: 3-months after inclusion
measure: Isometric Bench Press
timeFrame: 6-months after inclusion (primary endpoint)
measure: Isometric Bench Press
timeFrame: 1 month after ended treatment
measure: Isometric Bench Press
timeFrame: 1 year after ended treatment
measure: Hand Grip strength
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Hand Grip strength
timeFrame: 3-months after inclusion
measure: Hand Grip strength
timeFrame: 6-months after inclusion (primary endpoint)
measure: Hand Grip strength
timeFrame: 1 month after ended treatment
measure: Hand Grip strength
timeFrame: 1 year after ended treatment
measure: Six Minutes Walk Test
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Six Minutes Walk Test
timeFrame: 3-months after inclusion
measure: Six Minutes Walk Test
timeFrame: 6-months after inclusion (primary endpoint)
measure: Six Minutes Walk Test
timeFrame: 1 month after ended treatment
measure: Six Minutes Walk Test
timeFrame: 1 year after ended treatment
measure: Thirty Seconds and One-Minute Sit-to-stand
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Thirty Seconds and One-Minute Sit-to-stand
timeFrame: 3-months after inclusion
measure: Thirty Seconds and One-Minute Sit-to-stand
timeFrame: 6-months after inclusion (primary endpoint)
measure: The timed Up-and-Go Test:
timeFrame: 3-months after inclusion
measure: Thirty Seconds and One-Minute Sit-to-stand
timeFrame: 1 month after ended treatment
measure: Thirty Seconds and One-Minute Sit-to-stand
timeFrame: 1 year after ended treatment
measure: The timed Up-and-Go Test:
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: The timed Up-and-Go Test:
timeFrame: 6-months after inclusion (primary endpoint)
measure: The timed Up-and-Go Test:
timeFrame: 1 month after ended treatment
measure: The timed Up-and-Go Test:
timeFrame: 1 year after ended treatment
measure: Hospitalized days
timeFrame: measured 6 months after inclusion (primary endpoint)
measure: Hospitalized days
timeFrame: 1month after ended treatment
measure: Hospitalized days
timeFrame: 1 year after ended treatment
measure: Body composition: Bone Mineral Density
timeFrame: within 2 weeks of treatment initiation
measure: Body composition: Bone Mineral Content
timeFrame: within 2 weeks of treatment initiation
measure: Body composition: Body Fat
timeFrame: within 2 weeks of treatment initiation
measure: Body composition: Fat-Free Mass
timeFrame: within 2 weeks of treatment initiation
measure: Body composition: Bone Mineral Density
timeFrame: 6 months after inclusion (before a treatment block)
measure: Body composition: Bone Mineral Content
timeFrame: 6 months after inclusion (before a treatment block)
measure: Body composition: Body Fat
timeFrame: 6 months after inclusion (before a treatment block)
measure: Body composition: Fat-Free Mass
timeFrame: 6 months after inclusion (before a treatment block)
measure: Body composition: Bone Mineral Density
timeFrame: 1 month after ended treatment.
measure: Body composition: Bone Mineral Content
timeFrame: 1 month after ended treatment.
measure: Body composition: Body Fat
timeFrame: 1 month after ended treatment.
measure: Body composition: Fat-Free Mass
timeFrame: 1 month after ended treatment.
measure: Body composition: Bone Mineral Density
timeFrame: 1 year after end of treatment (primary endpoint).
measure: Body composition: Bone Mineral Content
timeFrame: 1 year after end of treatment (primary endpoint).
measure: Body composition: Body Fat
timeFrame: 1 year after end of treatment (primary endpoint).
measure: Body composition: Fat-Free Mass
timeFrame: 1 year after end of treatment (primary endpoint).
measure: The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
timeFrame: Within 2 weeks of treatment initiation
measure: The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
timeFrame: 6-months after inclusion.
measure: The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
timeFrame: 1 month after ended treatment
measure: The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
timeFrame: 1 year after ended treatment
measure: Prevalence of metabolic syndrome
timeFrame: within 2 weeks of treatment initiation.
measure: Prevalence of metabolic syndrome
timeFrame: 6 months after inclusion (before a treatment block)
measure: Prevalence of metabolic syndrome
timeFrame: 1 month after ended treatment.
measure: Prevalence of metabolic syndrome
timeFrame: 1 year after end of treatment (primary endpoint)
Other outcomes:
measure: Metabolomics (explorative outcome)
timeFrame: within 2 weeks of treatment initiation, at 6 months (before a treatment block), one month after ended treatment and 1 year after end of treatment.
measure: Metabolomics (explorative outcome)
timeFrame: 6 months after inclusion (before a treatment block.
measure: Metabolomics (explorative outcome)
timeFrame: 1 month after ended treatment.
measure: Metabolomics (explorative outcome)
timeFrame: 1 year after end of treatment.
measure: Dietary assessment (explorative outcome)
timeFrame: within 2 weeks of treatment initiation
measure: Dietary assessment (explorative outcome)
timeFrame: 6 months after inclusion (before a treatment block),
measure: Dietary assessment (explorative outcome)
timeFrame: 1 month after ended treatment.
measure: Dietary assessment (explorative outcome)
timeFrame: 1 year after end of treatment.
measure: Intestinal microbiota (explorative outcome)
timeFrame: within 2 weeks of treatment initiation, at 6 months (before a treatment block), one month after ended treatment and 1 year after end of treatment.
measure: Intestinal microbiota (explorative outcome)
timeFrame: within 2 weeks of treatment initiation.
measure: Intestinal microbiota (explorative outcome)
timeFrame: 6 months after inclusion (before a treatment block.
measure: Intestinal microbiota (explorative outcome)
timeFrame: 1month after ended treatment.
measure: Intestinal microbiota (explorative outcome)
timeFrame: 1 year after end of treatment.
measure: Inflammatory cytokines and mediators (explorative outcome)
timeFrame: within 2 weeks of treatment initiation
measure: Inflammatory cytokines and mediators (explorative outcome)
timeFrame: 6 months after inclusion (before a treatment block).
measure: Inflammatory cytokines and mediators (explorative outcome)
timeFrame: 1 month after ended treatment.
measure: Inflammatory cytokines and mediators (explorative outcome)
timeFrame: 1 year after end of treatment.
measure: Growth and Reproduction (explorative outcome)
timeFrame: within 2 weeks of treatment initiation.
measure: Growth and Reproduction (explorative outcome)
timeFrame: 6 months after inclusion (before a treatment block)
measure: Growth and Reproduction (explorative outcome)
timeFrame: 1 month after ended treatment.
measure: Growth and Reproduction (explorative outcome)
timeFrame: 1 year after end of treatment.
measure: Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
timeFrame: 6-months after inclusion
measure: Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
timeFrame: 3-months after inclusion
measure: Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
timeFrame: 1 month after ended treatment
measure: Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
timeFrame: 1 year after ended treatment
measure: Neuropathy - Ped-mTNS (explorative outcome)
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Neuropathy - Ped-mTNS (explorative outcome)
timeFrame: 3-months after inclusion
measure: Neuropathy - Ped-mTNS (explorative outcome)
timeFrame: 6-months after inclusion
measure: Neuropathy - Ped-mTNS (explorative outcome)
timeFrame: one month after ended treatment
measure: Neuropathy - Ped-mTNS (explorative outcome)
timeFrame: 1 year after ended treatment
measure: Physio- and occupational therapy treatments (explorative outcome)
timeFrame: measured 6 months after inclusion
measure: Physio- and occupational therapy treatments (explorative outcome)
timeFrame: 1 month after ended treatment
measure: Physio- and occupational therapy treatments (explorative outcome)
timeFrame: 1 year after ended treatment
measure: General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: Within 2 weeks of treatment initiation.
measure: General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report: (explorative outcome)
timeFrame: 6-months after inclusion.
measure: General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: 1 month after ended treatment.
measure: General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: 1 year after ended treatment.
measure: The PedsQL 3.0 Cancer Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report
timeFrame: Within 2 weeks of treatment initiation.
measure: The PedsQL 3.0 Cancer Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: 6 months after inclusion
measure: PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: Within 2 weeks of treatment initiation.
measure: PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: 6 months after inclusion.
measure: PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: 1 month after ended treatment.
measure: PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
timeFrame: 1 year after end of treatment.
measure: Self-Efficacy for Exercise scale (SEE-DK) (explorative outcome)
timeFrame: monthly, up to 6 months after inclusion
measure: Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
timeFrame: Within 2 weeks of treatment initiation (baseline)
measure: Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
timeFrame: 3-months after inclusion
measure: Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
timeFrame: 6-months after inclusion
measure: Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
timeFrame: 1 month after ended treatment
measure: Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
timeFrame: 1 year after ended treatment
measure: Facilitators and Barriers to Physical Activity, semi-structured in-depth interviews (explorative outcome)
timeFrame: within 6-months after treatment initiation
measure: Physical Activity behaviour (explorative outcome)
timeFrame: 1 year after ended treatment.
measure: Physical Activity behaviour (explorative outcome)
timeFrame: 1 month after ended treatment.
measure: Physical Activity behaviour (explorative outcome)
timeFrame: 6-months after inclusion (primary endpoint).
measure: Physical Activity behaviour (explorative outcome)
timeFrame: 3-months after inclusion
measure: Physical Activity behaviour (explorative outcome)
timeFrame: Within 2 weeks of treatment initiation
measure: Risk factors of metabolic syndrome: Body Mass Index
timeFrame: within 2 weeks of treatment initiation
measure: Risk factors of metabolic syndrome: Body Mass Index
timeFrame: 6 months after inclusion (before a treatment block)
measure: Risk factors of metabolic syndrome: Body Mass Index
timeFrame: 1 month after ended treatment
measure: Risk factors of metabolic syndrome: Body Mass Index
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
timeFrame: within 2 weeks of treatment initiation
measure: Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
timeFrame: 6 months after inclusion (before a treatment block)
measure: Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
timeFrame: 1 month after ended treatment
measure: Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
timeFrame: within 2 weeks of treatment initiation
measure: Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
timeFrame: 6 months after inclusion (before a treatment block)
measure: Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
timeFrame: 1 month after ended treatment
measure: Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
timeFrame: 1 year after end of treatment (primary endpoint)
measure: Risk factors of metabolic syndrome: hip circumference
timeFrame: within 2 weeks of treatment initiation
measure: Risk factors of metabolic syndrome: hip circumference
timeFrame: 6 months after inclusion (before a treatment block)
measure: Risk factors of metabolic syndrome: hip circumference
timeFrame: 1 month after ended treatment
measure: Risk factors of metabolic syndrome: hip circumference
timeFrame: 1 year after end of treatment (primary endpoint)
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Hanne B. Larsen, As. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.
citation: Fiuza-Luces C, Padilla JR, Soares-Miranda L, Santana-Sosa E, Quiroga JV, Santos-Lozano A, Pareja-Galeano H, Sanchis-Gomar F, Lorenzo-Gonzalez R, Verde Z, Lopez-Mojares LM, Lassaletta A, Fleck SJ, Perez M, Perez-Martinez A, Lucia A. Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. Med Sci Sports Exerc. 2017 Feb;49(2):223-230. doi: 10.1249/MSS.0000000000001094.
citation: Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, Wong G, Bennett P, Shaw J, Caprio S; IDF Consensus Group. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. 2007 Oct;8(5):299-306. doi: 10.1111/j.1399-5448.2007.00271.x. No abstract available.
citation: Schmidt-Andersen P, Fridh MK, Muller KG, Anna Pouplier, Hjalgrim LL, Faigenbaum AD, Schmiegelow K, Hasle H, Lykkedegn S, Zhang H, Christensen J, Larsen HB. Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer (INTERACT): Study Protocol for a Multicenter, Two-Arm Parallel-Group Randomized Controlled Superiority Trial. Front Pediatr. 2022 Mar 14;10:833850. doi: 10.3389/fped.2022.833850. eCollection 2022.