Clinical trial NCT05679817: How Effective is the Dose-graded Aerobic Training in Children Survivors of Acute Lymphoblastic Leukemia?
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, dual-arm, randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: 3 months
Secondary outcomes:
measure: Six-minute walk test.
timeFrame: 3 months
measure: Timed up and down stairs test
timeFrame: 3 months
measure: 4x10 meter Shuttle Run test
timeFrame: 3 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Ragab K. Elnaggar
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab K. Elnaggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: