Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia
Effects of a Physical Exercise Program in Patients With Diagnosis of Acute Lymphoblastic Leukemia
1 other identifier
interventional
24
1 country
1
Brief Summary
- Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL) strengthens their physical fitness.
- Exercising improves muscular and functional mobility fitness after finalizing chemotherapy in children and teenagers diagnosed with ALL.
- Assess cardiological changes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 29, 2016
CompletedDecember 29, 2016
December 1, 2016
3 months
December 13, 2016
December 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiorespiratory exercise test
For this test a treadmill was used utilizing a sloped ramp protocol
1 year
Secondary Outcomes (6)
Echocardiography
1 year
Functional mobility
1 year
Functional mobility
1 year
Strength
1 year
Flexibility
1 year
- +1 more secondary outcomes
Study Arms (4)
Evaluate physical fitness
EXPERIMENTALAn exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform
Evaluate Cardiological changes
EXPERIMENTALAn exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform
Evaluate activity physical
EXPERIMENTALAn exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform
control grup
NO INTERVENTIONThe control group will be recommended to maintain a level of physical activity they would routinely and habitually have during the 4 months that the study will last.
Interventions
An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform. The physiotherapist will contact the patient and/or tutor weekly so as to answer and doubts they may have with respect to the exercise program and to further supervise their compliance (group with intervention).
Eligibility Criteria
You may qualify if:
- The study included of children and adolescents between 7 and 18 years old that were at time in complete remission for a minimum of one year of their neoplastic disease and had finalized their chemotherapy treatments by the time they began the physical exercise program.
You may not qualify if:
- Patients with structural cardiac anomalies, congenital cardiopathies, those in recurrence of their neoplastic diseases, signs of clinical or subclinical cardiac insufficiency and an echocardiography with alterations in systolic and/or diastolic function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Claudia Delgado
Barcelona, Barcelona, 08025, Spain
Related Publications (1)
R. Peris-Bonet, D. Salmerón, M. A. Martínez-Beneito, J. Galceran, R. Marcos Gragera, S. Felipe, V. González & J. Sanchez de Toledo Codina. Childhood cancer incidence and survival in Spain. Annals of Oncology 2010: 21 arner JT.; Bell W.; Webb DK.; Gregory JW. Daily energy expenditure and physical activity in survivors of childhood malignancy. Pediatr Res 43. 1998, 607-613 Lucia A.; Earnest C.; Perez M. Cancer-related fatigue: can exercise physiology assist oncologists?. Lancet Oncol 4. 2003, 616-625 San Juan AF.; Fleck SJ.; Chamorro C.; Maté-Muñoz JL.; Garcia-Castro J.; Ramirez M.; Madero L.; Lucia A. Early-phase adaptations to intra-hospital training in strength and functional mobility of children with Leucemia.J Strength Cond Res. 2006
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 29, 2016
Study Start
June 1, 2015
Primary Completion
September 1, 2015
Study Completion
March 1, 2016
Last Updated
December 29, 2016
Record last verified: 2016-12