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

NCT ID: NCT06338020

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-29
• Study Completion Date: 2024-01-04

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.

Detailed Description

Sixty-two pediatric survivors of ALL participated in the study. They were recruited from the Pediatric Oncology/Hematology departments of three referral hospitals in Riyadh region, Saudi Arabia. They were between 12 and 18 years old, completed chemotherapy, had secondary sarcopenia, had normal cardiac structure and function, had no lower limb deformities, and did not engage in regular exercise regimens. They were excluded if they had secondary cancers, neurodegenerative impairments affecting memory, attention, or executive functioning, or neuro-musculoskeletal conditions likely to impede the training like recurrent intensive cramps or impaired proprioceptive functions.

Outcome measures

1. Muscle thickness: the thigh muscle thickness was assessed using a standard high-resolution ultrasound imaging system.

2. Muscle strength: The peak concentric torque of the right and left quadriceps was measured through an isokinetic dynamometer.

3. Fatigue: the general fatigue perception was evaluated using the Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale.

4. Functional capacity: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test.

The experimental group received an adaptive-VRT program, three times a week, for six consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The training protocol included maximum voluntary concentric knee flexor/extensor actions through a motion range between 10 and 90 degrees. Three sets of five to 10 repetitions at angular speeds of 240, 180, and 120 degrees/second were performed. The training started with a warm-up for 10 minutes and ended with a cool-down for 5 minutes.

The control group received the standard exercise program, 45 minutes per session, three times a week, for eight consecutive weeks. The program consisted of flexibility exercise, manual/mechanical strength training, and moderate-intensity aerobic exercises on a treadmill or bicycle ergometer.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adaptive-VRT

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

Group Type: EXPERIMENTAL

Adaptive variable-resistance training

Intervention Type: 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.

Standard Physical Therapy

Participants in this group received the standard exercise program.

Group Type: ACTIVE_COMPARATOR

Standard physical therapy

Intervention Type: 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.

Interventions

Adaptive variable-resistance training

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.

Intervention Type: OTHER

Standard physical therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ragab Kamal Elnaggar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ragab K. Elnaggar, PhD

Role: PRINCIPAL_INVESTIGATOR

Prince Sattam Bin Abdulaziz University

Locations

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

References

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.

Reference Type: DERIVED

PMID: 39985582 (View on PubMed)

Other Identifiers

RHPT/0022/0042

Identifier Type: -

Identifier Source: org_study_id