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

Cairo University (CU)

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Other: Traditional physical rehabilitation; Other: Dose-graded aerobic exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05679817

RHPT/0021/0089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

58 participants in 2 patient groups

D-GAE group

Experimental group

Description:

This group received a 12-week aerobic training in addition to the traditional physical rehabilitation.

Treatment:

Other: Dose-graded aerobic exercises

Control group

Active Comparator group

Description:

This group received the traditional physical rehabilitation only

Treatment:

Other: Traditional physical rehabilitation