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How Effective is the Dose-graded Aerobic Training in Children Survivors of Acute Lymphoblastic Leukemia?

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dose-graded aerobic exercises
Traditional physical rehabilitation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Inclusion Criteria: Survivors of childhood ALL Age of 10-18 years Completion of maintenance therapy Free of lower limb or spinal deformities Not participating in regular exercise regimens in the past six months Exclusion Criteria: Secondary malignancies Significant musculoskeletal/neurological issues Neurocognitive impairments

Sites / Locations

  • Ragab K. Elnaggar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

D-GAE group

Control group

Arm Description

This group received a 12-week aerobic training in addition to the traditional physical rehabilitation.

This group received the traditional physical rehabilitation only

Outcomes

Primary Outcome Measures

Peak oxygen uptake
The peak oxygen uptake (mL/kg/min) was assessed through a symptom-free exercise tolerance test (i.e., the McMaster cycling protocol).

Secondary Outcome Measures

Six-minute walk test.
This test identified the maximum distance (m) that each child was able to cover over six minutes on a straight flat 30-m walkway, without running or jogging. Walking is regarded as more efficient in line with a longer distance coverage
Timed up and down stairs test
This test measured the time (seconds) that each child took to climb up and down a 14-step stair flight (each 20 cm in height). Better performance is indicated by a shorter time.
4x10 meter Shuttle Run test
This test measured the time (seconds) that each child took to run forth and back a 10-meter track. Better performance is indicated by a shorter time.

Full Information

First Posted
December 24, 2022
Last Updated
December 24, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05679817
Brief Title
How Effective is the Dose-graded Aerobic Training in Children Survivors of Acute Lymphoblastic Leukemia?
Official Title
Effectiveness of a Dose-graded Aerobic Exercise Regimen on Cardiopulmonary Fitness and Physical Performance in Children Survivors of Acute Lymphoblastic Leukemia: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
November 24, 2022 (Actual)
Study Completion Date
November 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to evaluate the impact of a 12-week dose-graded aerobic exercise program (D-GAE) on cardiopulmonary fitness and physical performance in children survivors of acute lymphoblastic leukemia (ALL). A total of 58 ALL survivors were randomly assigned to the D-GAE group (n = 29, who underwent a combination of traditional physical rehabilitation and intensity- and duration-graded aerobic training three times per week for 12 weeks) or the control group (n = 29, who underwent only traditional physical rehabilitation). Cardiopulmonary fitness and physical performance were evaluated in both groups before and after treatment.
Detailed Description
Fifty-eight survivors of ALL were recruited from the hematology-oncology polyclinic at King Khalid Hospital and two referral pediatric hospitals in Riyadh, Saudi Arabia. The study included survivors aged 10-18 years, who completed maintenance therapy, had no abnormalities of the lower limbs or spine and did not participate in a regular exercise program (in the past six months). survivors who had secondary malignancies, significant musculoskeletal/neurological issues affecting the capacity to participate in exercises or neurocognitive impairments were excluded. Outcome measures Cardiopulmonary fitness: The peak oxygen uptake was assessed through the McMaster cycling protocol. Physical Performance: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test. Interventions The D-GAE group received a 12-week aerobic training, three times in addition to the traditional physical rehabilitation. The D-GAE program commenced with a training intensity corresponding to 50% of the maximum age-predicted heart rate for 25 minutes in the first two weeks, which progressed on a two-week basis, and ended up with a training intensity corresponding to 75% of the maximum age-predicted heart rate for 50 minutes in the last two weeks. The D-GAE program included a warm-up for 5 minutes and a cool-down for 5 minutes. The control group received the traditional physical rehabilitation only, 45 minutes per session, three times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strengthening exercises, balance training, and general conditioning exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, dual-arm, randomized controlled trial
Masking
Outcomes Assessor
Masking Description
A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment.
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-GAE group
Arm Type
Experimental
Arm Description
This group received a 12-week aerobic training in addition to the traditional physical rehabilitation.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group received the traditional physical rehabilitation only
Intervention Type
Other
Intervention Name(s)
Dose-graded aerobic exercises
Intervention Description
The D-GAE group received a 12-week aerobic training, three times in addition to the traditional physical rehabilitation. The D-GAE program commenced with a training intensity corresponding to 50% of the maximum age-predicted heart rate for 25 minutes in the first two weeks, which progressed on a two-week basis, and ended up with a training intensity corresponding to 75% of the maximum age-predicted heart rate for 50 minutes in the last two weeks. The D-GAE program included a warm-up for 5 minutes and a cool-down for 5 minutes
Intervention Type
Other
Intervention Name(s)
Traditional physical rehabilitation
Intervention Description
The control group received the traditional physical rehabilitation only, 45 minutes per session, three times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strengthening exercises, balance training, and general conditioning exercises.
Primary Outcome Measure Information:
Title
Peak oxygen uptake
Description
The peak oxygen uptake (mL/kg/min) was assessed through a symptom-free exercise tolerance test (i.e., the McMaster cycling protocol).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Six-minute walk test.
Description
This test identified the maximum distance (m) that each child was able to cover over six minutes on a straight flat 30-m walkway, without running or jogging. Walking is regarded as more efficient in line with a longer distance coverage
Time Frame
3 months
Title
Timed up and down stairs test
Description
This test measured the time (seconds) that each child took to climb up and down a 14-step stair flight (each 20 cm in height). Better performance is indicated by a shorter time.
Time Frame
3 months
Title
4x10 meter Shuttle Run test
Description
This test measured the time (seconds) that each child took to run forth and back a 10-meter track. Better performance is indicated by a shorter time.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Survivors of childhood ALL Age of 10-18 years Completion of maintenance therapy Free of lower limb or spinal deformities Not participating in regular exercise regimens in the past six months Exclusion Criteria: Secondary malignancies Significant musculoskeletal/neurological issues Neurocognitive impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab K. Elnaggar, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ragab K. Elnaggar
City
Al Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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How Effective is the Dose-graded Aerobic Training in Children Survivors of Acute Lymphoblastic Leukemia?

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