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Completed

NCT Number: NCT05679817

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dose-graded aerobic exercises

Other

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

Traditional physical rehabilitation

Other

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.

Primary outcomes

  1. 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

  1. Six-minute walk test.

    Time frame: 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

  2. Timed up and down stairs test

    Time frame: 3 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.

  3. 4x10 meter Shuttle Run test

    Time frame: 3 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2023
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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