Optimizing Recovery in Pediatric ALL Survivors: A Training Comparison

NCT07330141 | Completed

• 1 other identifier: RHPT/0023/0029
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Acute Lymphobkastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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).

  2 months

Secondary Outcomes (3)

• Six-minute walk test

  2 months

• 4x10 meter Shuttle Run test

  2 months

• Timed up and down stairs test

  2 months

Study Arms (3)

CL-AEx group

EXPERIMENTAL

The CL-AEx group received a 12-week constant-load aerobic training besides a structured exercise program.

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.

Other: Graded Aerobic exercise

Control group

ACTIVE COMPARATOR

The control group received the structured exercise program only for 12 consecutive weeks.

Other: Structured Exercise regemin

Interventions

Constant-load Aerobic Exercise OTHER

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.

CL-AEx group

Graded Aerobic exercise OTHER

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.

G-AEx group

Structured Exercise regemin OTHER

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.

Control group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Secondary cancers
• Neurodegenerative impairments affecting memory, attention, or executive functioning
• Neuro-musculoskeletal conditions are likely to impede the training.

Sponsors & Collaborators

• Cairo University: lead
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

Study Officials

• Ragab K Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, three-arm, randomized controlled trial

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: December 3, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)