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Acute Lymphoblastic LeukemiaPhase 1/2NCT03005392

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

A Phase 1/2 study testing exercise in people with Acute Lymphoblastic Leukemia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSpain
Study dates
Jun 2015to Mar 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Claudia Delgado

    Barcelona, Barcelona, 08025

Other trials in Spain

About this study

Official title: Effects of a Physical Exercise Program in Patients With Diagnosis of Acute Lymphoblastic Leukemia

  • 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
Read the 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

Being tested
exercise
Keywords
Cancer, Physical therapy, Cardiorespiratory fitness
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exerciseOther

    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).

Study groups in NCT03005392
Study groupRoleWhat they receive
Evaluate physical fitnessExperimentalAn 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
Receives: Other: exercise
Evaluate Cardiological changesExperimentalAn 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
Receives: Other: exercise
Evaluate activity physicalExperimentalAn 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
Receives: Other: exercise
control grupNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory exercise test

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

    Measured: 1 year

Secondary outcomes (6)

  1. 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.

    Measured: 1 year

  2. Functional mobility

    For this variable the Time Up and Go Test (TUG) was used

    Measured: 1 year

  3. Functional mobility

    For this variable the Time Up and Down Stairs Test (TUDS) was used

    Measured: 1 year

  4. Strength

    To measure this variable, the hand grip test was utilized

    Measured: 1 year

  5. Flexibility

    For this variable the sit-and-reach (SR) test was used, that of which allowed evaluation of the hamstring muscle extensibility

    Measured: 1 year

  6. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionSep 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03005392
Sponsor's protocol ID
IIBSP-EJE-2013-150
Status last verified
Dec 2016
First submitted
13 Dec 2016
Last updated
29 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing exercise in people with Acute Lymphoblastic Leukemia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory exercise test (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03005392, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.

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