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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03005392
Other study ID # IIBSP-EJE-2013-150
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 13, 2016
Last updated December 23, 2016
Start date June 2015
Est. completion date March 2016

Study information

Verified date December 2016
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2016
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 18 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
exercise
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).

Locations

Country Name City State
Spain Claudia Delgado Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory exercise test For this test a treadmill was used utilizing a sloped ramp protocol 1 year No
Secondary Echocardiography Index of the lateral mitral annulus level (isovolumetric contraction time
+ Isovolumetric relaxation time / ejection time), measured by Echocardiography. Index of TEI at the level of the septal mitral ring (isovolumetric contraction time + Isovolumetric relaxation time / ejection time), measured by means of Echocardiography. TEI index at the level of the tricuspid ring (isovolumetric contraction time + Isovolumetric relaxation time / ejection time), measured by means of Echocardiography.
1 year No
Secondary Functional mobility For this variable the Time Up and Go Test (TUG) was used 1 year No
Secondary Functional mobility For this variable the Time Up and Down Stairs Test (TUDS) was used 1 year No
Secondary Strength To measure this variable, the hand grip test was utilized 1 year No
Secondary Flexibility For this variable the sit-and-reach (SR) test was used, that of which allowed evaluation of the hamstring muscle extensibility 1 year No
Secondary Level of physical activity This variable was measured utilizing the family of the international questionnaire of physical activity (IPAQ). For children between the ages of 8-12 the Physical Activity Questionnaire for Children (PAQ-C) version was used, and for adolescents between the ages of 13-18 the PAQ-A form was used. 1 year No
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