Clinical trial NCT03005392: Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia
Official title: Effects of a Physical Exercise Program in Patients With Diagnosis of Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Cancer
Physical therapy
Cardiorespiratory fitness
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Children and adolescents survivors of ALL will be randomly assigned to the intervention group and to the control group. A home-exercise program will be designed for 16 weeks with 55 sessions, combining aerobic, strength and flexibility exercises of light and moderate intensity. The following tests will be performed to evaluate the effects of the intervention program: Echocardiography, Tape treadmill test using a ramp protocol to assess cardiorespiratory fitness, hand grip test to assess muscular grip strength, Timed Up test And Go Test (TUG) and Timed Up and Down Stairs Test (TUDS) to assess functional mobility, the sit and reach test to assess flexibility and a questionnaire to assess levels of physical activity. The control group will perform their usual physical activity

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cardiorespiratory exercise test
timeFrame: 1 year
Secondary outcomes:
measure: Echocardiography
timeFrame: 1 year
measure: Functional mobility
timeFrame: 1 year
measure: Functional mobility
timeFrame: 1 year
measure: Strength
timeFrame: 1 year
measure: Flexibility
timeFrame: 1 year
measure: Level of physical activity
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Claudia Delgado
Study officials:
References:
citation: 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