Acute Lymphobkastic LeukemiaNCT07330141
Optimizing Recovery in Pediatric ALL Survivors: A Training Comparison
A study testing Constant-load Aerobic Exercise, Graded Aerobic exercise and Structured Exercise regemin in people with Acute Lymphobkastic Leukemia, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study compared the effects of constant-load aerobic exercise (CL-AEx) and graded aerobic exercise (G-AEx) on cardiopulmonary fitness and functional capacity in pediatric survivors of acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Acute Lymphobkastic Leukemia
- What is being tested?
- Constant-load Aerobic Exercise, Graded Aerobic exercise and Structured Exercise regemin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Dec 2023to 31 Oct 2024
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 10 and 18 years old
- Complete maintenance chemotherapy
- Normal cardiac structure and function
- Absence of lower limb deformities
- Not engaging in regular exercise regimens
Who cannot join
- Secondary cancers
- Neurodegenerative impairments affecting memory, attention, or executive functioning
- Neuro-musculoskeletal conditions are likely to impede the training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Post-Chemotherapy Recovery: A Head-to-Head Trial of Graded vs. Constant-Load Aerobic Exercise in Pediatric ALL Survivors
This study compared the effects of constant-load aerobic exercise (CL-AEx) and graded aerobic exercise (G-AEx) on cardiopulmonary fitness and functional capacity in pediatric survivors of acute lymphoblastic leukemia (ALL).
A cohort of 72 pediatric ALL survivors was randomly assigned to one of three groups: a CL-AEx group (n=24), a G-AEx group (n=24), or a control group (n=24). All groups participated in a structured exercise regimen. The CL-AEx group performed additional moderate-intensity aerobic training at a fixed load, while the G-AEx group performed additional aerobic training with progressive increases in intensity and duration. The control group performed the structured exercise regimen only. Interventions were administered three times per week for 12 consecutive weeks.
Cardiopulmonary fitness and functional capacity were assessed in all three groups at baseline and following the completion of the 12-week intervention.
Read the detailed description
Seventy-two pediatric ALL survivors were recruited from the Pediatric Oncology and Hematology departments of three referral hospitals in the Riyadh region, Saudi Arabia. Inclusion criteria required participants to be aged 10-18 years, have completed chemotherapy, present with secondary sarcopenia, and possess normal cardiac structure and function without lower limb deformities. Participants were also required to be non-regular exercisers. Exclusion criteria included a history of secondary cancers, neurodegenerative impairments affecting memory, attention, or executive function, or any neuromusculoskeletal condition likely to impede training compliance (e.g., recurrent intensive cramps or impaired proprioceptive function).
Outcome Measures
Cardiopulmonary Fitness: Peak oxygen uptake (VO₂ peak) was assessed using the McMaster cycle ergometer protocol.
Functional Capacity: This was evaluated via three performance-based tests: the 6-Minute Walk Test (6MWT), the Timed Up and Down Stairs Test (TUDS), and the 4x10 Meter Shuttle Run Test.
Interventions
All interventions were delivered three times per week for 12 consecutive weeks under close supervision by an experienced pediatric physical therapist.
Constant-Load Aerobic Exercise (CL-AEx) Group: This group (n=24) performed a structured exercise regimen plus a moderate-intensity aerobic training program. The aerobic component was maintained at a constant intensity of 65% of the maximum age-predicted heart rate for 45 minutes per session, each preceded by a 5-minute warm-up and followed by a 5-minute cool-down.
Graded Aerobic Exercise (G-AEx) Group: This group (n=24) performed the same structured exercise regimen plus an aerobic program with progressive intensity and duration. Starting at 50% of maximum age-predicted heart rate for 25 minutes, the parameters were increased every two weeks, culminating at 75% for 50 minutes in the final two weeks. Each session also included a 5-minute warm-up and cool-down.
Control Group: This group (n=24) performed only the structured exercise regimen for 45 minutes per session. The regimen included flexibility exercises, progressive resistance training, balance training, and conditioning activities.
- Conditions
- Acute Lymphobkastic Leukemia
- Being tested
- Constant-load Aerobic Exercise, Graded Aerobic exercise, Structured Exercise regemin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant-load Aerobic ExerciseOther
The CL-AEx group completed a 12-week, moderate-intensity aerobic training program in addition to the structured exercise regimen. The aerobic component was performed three times per week at a fixed intensity of 65% of the maximum age-predicted heart rate for 45 minutes per session. Each session included a 5-minute warm-up and a 5-minute cool-down. The intensity and duration remained constant throughout the intervention period.
Graded Aerobic exerciseOther
The G-AEx group completed a 12-week aerobic training program that progressively increased in intensity and duration, in addition to the structured exercise regimen. Sessions were conducted three times per week. The program commenced at an intensity of 50% of the maximum age-predicted heart rate for 25 minutes. Parameters were increased every two weeks, culminating in an intensity of 75% for 50 minutes during the final two weeks. Each session included a standard 5-minute warm-up and 5-minute cool-down.
Structured Exercise regeminOther
The structured exercise regimen was conducted three times per week for 45 minutes per session over 12 consecutive weeks. Each session consisted of flexibility exercises, progressive resistance training, balance training, and low-intensity conditioning activities.
| Study group | Role | What they receive |
|---|---|---|
| CL-AEx group | Experimental | The CL-AEx group received a 12-week constant-load aerobic training besides a structured exercise program. Receives: Other: Constant-load Aerobic Exercise |
| G-AEx group | Experimental | The G-AEx group received a 12-week intensity- and duration-graded aerobic training in addition to a structured exercise program. Receives: Other: Graded Aerobic exercise |
| Control group | Active comparator | The control group received the structured exercise program only for 12 consecutive weeks. Receives: Other: Structured Exercise regemin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (3)
Six-minute walk test
This test identified the maximum distance (m) that each patient 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.
Measured: 2 months
4x10 meter Shuttle Run test
This test identified the maximum distance (m) that each patient 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.
Measured: 2 months
Timed up and down stairs test
This test measured the time (seconds) that each patient took to climb up and down a 14-step stair flight (each 20 cm in height). Better performance is indicated by a shorter time.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start3 Dec 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphobkastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, three-arm, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330141
- Sponsor's protocol ID
- RHPT/0023/0029
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Post-Chemotherapy Recovery: A Head-to-Head Trial of Graded vs. Constant-Load Aerobic Exercise in Pediatric ALL Survivors
- ClinicalTrials.gov ID
- NCT07330141
- Acronym / sponsor ID
- RHPT/0023/0029
- Conditions
- Acute Lymphobkastic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared the effects of constant-load aerobic exercise (CL-AEx) and graded aerobic exercise (G-AEx) on cardiopulmonary fitness and functional capacity in pediatric survivors of acute lymphoblastic leukemia (ALL).
A cohort of 72 pediatric ALL survivors was randomly assigned to one of three groups: a CL-AEx group (n=24), a G-AEx group (n=24), or a control group (n=24). All groups participated in a structured exercise regimen. The CL-AEx group performed additional moderate-intensity aerobic training at a fixed load, while the G-AEx group performed additional aerobic training with progressive increases in intensity and duration. The control group performed the structured exercise regimen only. Interventions were administered three times per week for 12 consecutive weeks.
Cardiopulmonary fitness and functional capacity were assessed in all three groups at baseline and following the completion of the 12-week intervention.
Detailed description
Seventy-two pediatric ALL survivors were recruited from the Pediatric Oncology and Hematology departments of three referral hospitals in the Riyadh region, Saudi Arabia. Inclusion criteria required participants to be aged 10-18 years, have completed chemotherapy, present with secondary sarcopenia, and possess normal cardiac structure and function without lower limb deformities. Participants were also required to be non-regular exercisers. Exclusion criteria included a history of secondary cancers, neurodegenerative impairments affecting memory, attention, or executive function, or any neuromusculoskeletal condition likely to impede training compliance (e.g., recurrent intensive cramps or impaired proprioceptive function).
Outcome Measures
Cardiopulmonary Fitness: Peak oxygen uptake (VO₂ peak) was assessed using the McMaster cycle ergometer protocol.
Functional Capacity: This was evaluated via three performance-based tests: the 6-Minute Walk Test (6MWT), the Timed Up and Down Stairs Test (TUDS), and the 4x10 Meter Shuttle Run Test.
Interventions
All interventions were delivered three times per week for 12 consecutive weeks under close supervision by an experienced pediatric physical therapist.
Constant-Load Aerobic Exercise (CL-AEx) Group: This group (n=24) performed a structured exercise regimen plus a moderate-intensity aerobic training program. The aerobic component was maintained at a constant intensity of 65% of the maximum age-predicted heart rate for 45 minutes per session, each preceded by a 5-minute warm-up and followed by a 5-minute cool-down.
Graded Aerobic Exercise (G-AEx) Group: This group (n=24) performed the same structured exercise regimen plus an aerobic program with progressive intensity and duration. Starting at 50% of maximum age-predicted heart rate for 25 minutes, the parameters were increased every two weeks, culminating at 75% for 50 minutes in the final two weeks. Each session also included a 5-minute warm-up and cool-down.
Control Group: This group (n=24) performed only the structured exercise regimen for 45 minutes per session. The regimen included flexibility exercises, progressive resistance training, balance training, and conditioning activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, three-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| CL-AEx group | Experimental | Other: Constant-load Aerobic ExerciseThe CL-AEx group received a 12-week constant-load aerobic training besides a structured exercise program. |
| G-AEx group | Experimental | Other: Graded Aerobic exerciseThe G-AEx group received a 12-week intensity- and duration-graded aerobic training in addition to a structured exercise program. |
| Control group | Active comparator | Other: Structured Exercise regeminThe control group received the structured exercise program only for 12 consecutive weeks. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 10 and 18 years old
- Complete maintenance chemotherapy
- Normal cardiac structure and function
- Absence of lower limb deformities
- Not engaging in regular exercise regimens
Key exclusion criteria (3 listed)
- Secondary cancers
- Neurodegenerative impairments affecting memory, attention, or executive functioning
- Neuro-musculoskeletal conditions are likely to impede the training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constant-load Aerobic ExerciseThe CL-AEx group completed a 12-week, moderate-intensity aerobic training program in addition to the structured exercise regimen. The aerobic component was performed three times per week at a fixed intensity of 65% of the maximum age-predicted heart rate for 45 minutes per session. Each session included a 5-minute warm-up and a 5-minute cool-down. The intensity and duration remained constant throughout the intervention period. | Other | CL-AEx group |
| Graded Aerobic exerciseThe G-AEx group completed a 12-week aerobic training program that progressively increased in intensity and duration, in addition to the structured exercise regimen. Sessions were conducted three times per week. The program commenced at an intensity of 50% of the maximum age-predicted heart rate for 25 minutes. Parameters were increased every two weeks, culminating in an intensity of 75% for 50 minutes during the final two weeks. Each session included a standard 5-minute warm-up and 5-minute cool-down. | Other | G-AEx group |
| Structured Exercise regeminThe structured exercise regimen was conducted three times per week for 45 minutes per session over 12 consecutive weeks. Each session consisted of flexibility exercises, progressive resistance training, balance training, and low-intensity conditioning activities. | Other | Control group |
Primary outcome
Peak oxygen uptake
Time frame: 2 months
The peak oxygen uptake (mL/kg/min) was assessed through a symptom-free exercise tolerance test (i.e., the McMaster cycling protocol).
3 secondary outcomes
Six-minute walk test
Time frame: 2 months
4x10 meter Shuttle Run test
Time frame: 2 months
Timed up and down stairs test
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constant-load Aerobic Exercise, Graded Aerobic exercise and Structured Exercise regemin in people with Acute Lymphobkastic Leukemia, run by Cairo University at 1 site in Saudi Arabia.
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 5 inclusion and 3 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 26 Jun 2026. 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 Saudi Arabia. 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.
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?
Peak oxygen uptake (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.