NCT05679817

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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 1. Cardiopulmonary fitness: The peak oxygen uptake was assessed through the McMaster cycling protocol. 2. 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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	Dose-graded aerobic exercises	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
OTHER	Traditional physical rehabilitation	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.

Timeline

• Start date: 2021-10-03
• Primary completion: 2022-11-24
• Completion: 2022-11-24
• First posted: 2023-01-11
• Last updated: 2023-01-11

Locations

1 site across 1 country: Saudi Arabia