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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03005392
Enrollment
24
Registered
2016-12-29
Start date
2015-06-30
Completion date
2016-03-31
Last updated
2016-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

Cancer, Physical therapy, Cardiorespiratory fitness

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

Interventions

OTHERexercise

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).

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiorespiratory exercise test1 yearFor this test a treadmill was used utilizing a sloped ramp protocol

Secondary

MeasureTime frameDescription
Echocardiography1 yearIndex 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.
Functional mobility1 yearFor this variable the Time Up and Go Test (TUG) was used
Strength1 yearTo measure this variable, the hand grip test was utilized
Flexibility1 yearFor this variable the sit-and-reach (SR) test was used, that of which allowed evaluation of the hamstring muscle extensibility
Level of physical activity1 yearThis 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026