Trial Title:
Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation
NCT ID:
NCT06300515
Condition:
Hematopoietic System--Cancer
Conditions: Keywords:
exercise
pediatric cancer
health counseling
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
The staff in charge of outcome assessment will be blinded to the group assigned to each
participant.
Intervention:
Intervention type:
Behavioral
Intervention name:
Control Group (Active Comparator)
Description:
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).
Arm group label:
Control
Other name:
Health Counseling only
Intervention type:
Behavioral
Intervention name:
Intervention Group
Description:
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: 30 to 55-60 minutes Aerobic
training (5-25 minutes): bicycling, crank-ergometry, circuit-style exercises, and games.
Muscle strength training (10-20 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.
Inspiratory muscle training will also be performed (5 min daily, using a specific device
that creates resistance against inspiration).
Arm group label:
Exercise
Other name:
Health Counseling + Exercise
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 physical-functional, behavioral, psycho-cognitive and clinical
outcomes, and blood biomarkers. The investigators will also determine to what extent the
benefits of this intervention are maintained over time. Additionally, the investigators
will determine the feasibility of implementing the proposed intervention in a real
clinical situation in 3 different pediatric HSCT units.
Detailed description:
Hematopoietic stem cell transplantation (HSCT), which is used to treat high-risk
malignancies, as well as some other conditions or even autoimmune processes, consists of
several phases: mobilization and subsequent collection of hematopoietic stem cells from
the patient (autologous HSCT) or from a donor (allogeneic HSCT); pre-HSCT conditioning;
infusion of patient/donor cells; establishment of a new immune and hematopoietic system
in the recipient; and prophylaxis/treatment of possible adverse effects. Since the first
successful allogeneic transplant was performed in 1968, thanks to the advances
experienced in conditioning regimens, as well as in donor-recipient histocompatibility
testing, in patient care and in the management of graft versus host disease (GvHD),
together with the increase in the number of donors, the expectations of children and
adolescents who receive HSCT have improved, achieving long-term survival rates (>5 years)
>70%. Yet survivors are at high risk of suffering side effects and toxicities derived
from the HSCT itself and/or the underlying disease, with subsequent functional decline.
In addition, they show a higher risk of rehospitalization than pediatric cancer survivors
who did not receive HSCT and tend to develop chronic pathologies (especially
cardiometabolic conditions and frailty) at earlier stages of adulthood than the general
population.
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 the following outcomes assessed at 3 time points
[start of hospitalization for HSCT (i.e., baseline), and 8 weeks and 3 months after
hospital discharge, respectively]: cardiorespiratory fitness (primary outcome) and
ventilatory threshold, muscle strength, left ventricle ejection fraction, fractional
shortening and global longitudinal strain, total cardiac mass, functional mobility,
adiposity (waist to hip ratio), body mass index, dual-energy X-ray absorptiometry
(DXA)-determined body composition (lean and fat mass, bone mineral density),
accelerometry-determined physical activity levels, ankle dorsiflexion range of motion,
health-related quality of life, cancer-related fatigue, and immune subpopulations. We
will also determine clinical outcomes during hospitalization (survival, treatment
tolerability, toxicities) as well as molecular biomarkers in blood.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
4 Years
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Start date:
April 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Alejandro Lucia
Agency class:
Other
Collaborator:
Agency:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Agency class:
Other
Collaborator:
Agency:
Hospital General Universitario Gregorio Marañon
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario La Paz
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario 12 de Octubre
Agency class:
Other
Source:
Universidad Europea de Madrid
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300515
