Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation

NCT06300515 | Recruiting

• 1 other identifier: PI23/00396
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Thanks to medical advances, survival rates \>5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.

Conditions

Hematopoietic System--Cancer

Keywords

exercise; pediatric cancer; health counseling

Outcome Measures

Primary Outcomes (1)

• Change in unilateral knee-extension muscle strength (from baseline to end of treatment)

  Unilateral knee-extension muscle strength will be assessed using a 5-RM test

  Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)

Secondary Outcomes (160)

• Change in unilateral knee-extension muscle strength (from baseline to follow-up)

  Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

• Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to end of treatment)

  Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)

• Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to follow-up)

  Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

• Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to end of treatment)

  Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)

• Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to follow-up)

  Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

Study Arms (2)

Control

ACTIVE COMPARATOR

During the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the control group will participate in a Health Counseling Program (1 time/week) on aspects related to a healthy lifestyle such as reducing sedentary lifestyle, acquiring healthy nutritional habits, the importance sleep, screen use, and how to address barriers related to clinical status. We will adapt the program to the needs and timing of the patient's treatment, providing the content in one session/week orally (e.g. using presentations) and in writing (e.g. through brochures).

Behavioral: Control Group (Active Comparator)

Exercise

EXPERIMENTAL

During the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the intervention group will participate in exactly the same Health Counseling Program as the Control group. Additionally, this group will perform an exercise program combining aerobic and muscle strength exercises

Behavioral: Intervention Group

Interventions

Control Group (Active Comparator) BEHAVIORAL

During the intervention phase (hospitalization for HSCT and subsequent 8-week outpatient phase following discharge), the control group will participate in a Health Counseling Program (1 time/week) on aspects related to a healthy lifestyle such as reducing sedentary lifestyle, acquiring healthy nutritional habits, the importance sleep, screen use, and how to address barriers related to clinical status. We will adapt the program to the needs and timing of the patient's treatment, providing the content in one session/week orally (e.g. using presentations) and in writing (e.g. through brochures).

Also known as: Health Counseling only

Control

Intervention Group BEHAVIORAL

Same as Control Group + exercise program as described below: Same as Control Group + exercise program as described below: Hospital ward (during HSCT); and Hospital Gym or online (patients' home) during the outpatient phase. Frequency: 3-5 days/week. Session duration: 15 to 65 minutes. Muscle strength training (30 minutes): large muscle group exercises (upper/lower limb + trunk exercises) performed as a circuit using body weight or against resistance (against gravity and with body weight, elastic bands, dumbbells, weighted vests, machines), with a wide range of joint mobility and at submaximal/maximum voluntary speed. Aerobic training (10-20 minutes): bicycling, crank-ergometry, circuit-style exercises, and games. Inspiratory muscle training will also be performed (5 min daily, using a specific device that creates resistance against inspiration).

Also known as: Health Counseling + Exercise

Exercise

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 4 and 21 years.
• Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid
• Undergoing treatment and follow-up in the same hospital.
• Speaking Spanish.
• Providing signed informed consent.

You may not qualify if:

• Not being able to participate in the trial according to protocol.
• Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems.
• Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements.
• Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol.
• Inability to understand the requirements of the study.

Sponsors & Collaborators

• Alejandro Lucia: lead
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (1)

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity; Neoplasms

Interventions

Control Groups; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Carmen Fiuza-Luces, PhD

CONTACT

+34658961509; cfiuza.imas12@h12o.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The staff in charge of outcome assessment will be blinded to the group assigned to each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

ES (1)