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Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
exercise
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Cancer, Physical therapy, Cardiorespiratory fitness

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Claudia Delgado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Evaluate physical fitness

Evaluate Cardiological changes

Evaluate activity physical

control grup

Arm Description

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

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

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 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.

Outcomes

Primary Outcome Measures

Cardiorespiratory exercise test
For this test a treadmill was used utilizing a sloped ramp protocol

Secondary Outcome Measures

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.
Functional mobility
For this variable the Time Up and Go Test (TUG) was used
Functional mobility
For this variable the Time Up and Down Stairs Test (TUDS) was used
Strength
To measure this variable, the hand grip test was utilized
Flexibility
For this variable the sit-and-reach (SR) test was used, that of which allowed evaluation of the hamstring muscle extensibility
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.

Full Information

First Posted
December 13, 2016
Last Updated
December 23, 2016
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT03005392
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Cancer, Physical therapy, Cardiorespiratory fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluate physical fitness
Arm Type
Experimental
Arm Description
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
Arm Title
Evaluate Cardiological changes
Arm Type
Experimental
Arm Description
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
Arm Title
Evaluate activity physical
Arm Type
Experimental
Arm Description
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
Arm Title
control grup
Arm Type
No Intervention
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
Cardiorespiratory exercise test
Description
For this test a treadmill was used utilizing a sloped ramp protocol
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Echocardiography
Description
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.
Time Frame
1 year
Title
Functional mobility
Description
For this variable the Time Up and Go Test (TUG) was used
Time Frame
1 year
Title
Functional mobility
Description
For this variable the Time Up and Down Stairs Test (TUDS) was used
Time Frame
1 year
Title
Strength
Description
To measure this variable, the hand grip test was utilized
Time Frame
1 year
Title
Flexibility
Description
For this variable the sit-and-reach (SR) test was used, that of which allowed evaluation of the hamstring muscle extensibility
Time Frame
1 year
Title
Level of physical activity
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Claudia Delgado
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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
Results Reference
result

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Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia

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