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Clinical Trials/NCT05679817
NCT05679817
Completed
Not Applicable

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

Cairo University1 site in 1 country58 target enrollmentOctober 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Lymphoblastic Leukemia
Sponsor
Cairo University
Enrollment
58
Locations
1
Primary Endpoint
Peak oxygen uptake
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2021
End Date
November 24, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ragab Kamal Elnaggar

Associate Professor

Cairo University

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

Outcomes

Primary Outcomes

Peak oxygen uptake

Time Frame: 3 months

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

Secondary Outcomes

  • 4x10 meter Shuttle Run test(3 months)
  • Six-minute walk test.(3 months)
  • Timed up and down stairs test(3 months)

Study Sites (1)

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