Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia

NCT06338020 | Completed

• 1 other identifier: RHPT/0022/0042
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to investigate the effect of eight weeks of adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in a convenience sample of pediatric survivors of acute lymphoblastic leukemia (ALL). Sixty-two pediatric survivors of ALL were randomly allocated to the experimental group (n = 31, received the adaptive variable-resistance training) or the Control group (n = 31, received standard physical therapy care). Both groups were assessed for muscle mass, strength, fatigue, and functional capacity before and after treatment.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Thigh muscle thickness

  The distance between the anterior fascia of the rectus femoris muscle and the posterior fascia of the vastus intermedius muscle. It was measured using a high-resolution ultrasound imaging system.

  2 months

• Muscle strength

  Muscle strength was indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.

  2 months

Secondary Outcomes (4)

• Fatigue

  2 months

• Six-minute walk test

  2 months

• 4x10 meter Shuttle Run test

  2 months

• Timed up and down stairs test

  2 months

Study Arms (2)

Adaptive-VRT

EXPERIMENTAL

Participants in this group received the adaptive variable-resistance training program in besides the standard physical therapy care.

Other: Adaptive variable-resistance training

Standard Physical Therapy

ACTIVE COMPARATOR

Participants in this group received the standard exercise program.

Other: Standard physical therapy

Interventions

Adaptive variable-resistance training OTHER

The training was conducted thrice weekly for eight successive weeks under the close supervision of a licensed pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association. The training protocol included maximum voluntary concentric knee flexor/extensor actions. Three sets of five to 10 repetitions of maximum-effort concentric action at angular speeds of 240, 180, and 120 degrees/second. The training started with a 10-minute warm-up exercise and ended up with a 5-minute cool-down exercise.

Adaptive-VRT

Standard physical therapy OTHER

The program encompassed the standard exercises for survivors of ALL (flexibility, graduated active strengthening, and conditioning exercises). The training was conducted for 45 minutes, two times a week for six successive weeks.

Standard Physical Therapy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 12 and 18 years old
• Complete maintenance chemotherapy
• Secondary sarcopenia
• Normal cardiac structure and function
• Absence of lower limb deformities
• Not engaging in regular exercise regimens

You may not qualify if:

• Secondary cancers
• Neurodegenerative impairments affecting memory, attention, or executive functioning
• Neuro-musculoskeletal conditions are likely to impede the training.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

Related Publications (1)

• Elnaggar RK, Mahmoud WS, Abdrabo MS, Elfakharany MS. Effect of adaptive variable-resistance training on chemotherapy-induced sarcopenia, fatigue, and functional restriction in pediatric survivors of acute lymphoblastic leukemia: a prospective randomized controlled trial. Support Care Cancer. 2025 Feb 22;33(3):214. doi: 10.1007/s00520-025-09250-x.

  PMID: 39985582 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ragab K. Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, dual-arm, randomized controlled trial

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: December 29, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)