Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer

NCT04706676 | Active Not Recruiting DMC

• 4 other identifiers: INTERACT-20202019-5954E-22597-0120-B-0409
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

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).

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

Outcome Measures

Primary Outcomes (5)

• Lower extremity isometric knee extension strength

  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.

  Within 2 weeks of treatment initiation (baseline)

• Lower extremity isometric knee extension strength

  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.

  3-months after inclusion

• Lower extremity isometric knee extension strength

  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.

  6-months after inclusion (primary endpoint)

• Lower extremity isometric knee extension strength

  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.

  1 month after ended treatment

• Lower extremity isometric knee extension strength

  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.

  1 year after ended treatment

Secondary Outcomes (72)

• 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

Other Outcomes (72)

• Metabolomics (explorative outcome)

  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.

• Metabolomics (explorative outcome)

  6 months after inclusion (before a treatment block.

• Metabolomics (explorative outcome)

  1 month after ended treatment.

Study Arms (2)

Integrative neuromuscular training + motivational counseling + usual care

EXPERIMENTAL

General and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility.

Behavioral: Integrative neuromuscular training (INT); Behavioral: motivational counseling session

Active control group + motivational counseling + usual care

ACTIVE COMPARATOR

home-based training program

Behavioral: Active control group: home-based training program; Behavioral: motivational counseling session

Interventions

Integrative neuromuscular training (INT) BEHAVIORAL

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.

Integrative neuromuscular training + motivational counseling + usual care

Active control group: home-based training program BEHAVIORAL

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.

Active control group + motivational counseling + usual care

motivational counseling session BEHAVIORAL

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.

Active control group + motivational counseling + usual care; Integrative neuromuscular training + motivational counseling + usual care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (3)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (4)

• 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.

  PMID: 24229362 BACKGROUND

• 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.

  PMID: 27631396 BACKGROUND

• 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.

  PMID: 17850473 BACKGROUND

• 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.

  PMID: 35359909 DERIVED

MeSH Terms

Conditions

Neoplasms; Leukemia; Lymphoma; Central Nervous System Neoplasms; Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Hanne B. Larsen, As. Prof

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 13, 2021
• Study Start: January 26, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)