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

Not Applicable
Completed
Conditions
Acute Lymphoblastic Leukemia
Interventions
Other: Traditional physical rehabilitation
Other: Dose-graded aerobic exercises
Registration Number
NCT05679817
Lead Sponsor
Cairo University
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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control groupTraditional physical rehabilitationThis group received the traditional physical rehabilitation only
D-GAE groupDose-graded aerobic exercisesThis group received a 12-week aerobic training in addition to the traditional physical rehabilitation.
Primary Outcome Measures
NameTimeMethod
Peak oxygen uptake3 months

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
NameTimeMethod
4x10 meter Shuttle Run test3 months

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.

Six-minute walk test.3 months

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 test3 months

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.

Trial Locations

Locations (1)

Ragab K. Elnaggar

🇸🇦

Al Kharj, Riyadh, Saudi Arabia

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