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Completed

NCT Number: NCT06338020

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

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.

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Key information

Age range

12 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

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

  • Muscle thickness: the thigh muscle thickness was assessed using a standard high-resolution ultrasound imaging system.
  • Muscle strength: The peak concentric torque of the right and left quadriceps was measured through an isokinetic dynamometer.
  • Fatigue: the general fatigue perception was evaluated using the Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Thigh muscle thickness

    Time frame: 2 months

    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. Muscle strength

    Time frame: 2 months

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

Secondary outcomes

  1. Fatigue

    Time frame: 2 months

    The general, sleep/rest, and cognitive fatigue perception was collectively measured using the Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale. It is an 18-item scale measure fatigue in three domains (i.e., general, sleep/rest, and cognitive fatigue). Items are rated on a 5-point scale (0-4; where 0 means "never" and 4 means "almost always"). The total score was calculated and was then linearly transformed on a 0-100 scale. Higher scores indicate less fatigue and better functioning.

  2. Six-minute walk test

    Time frame: 2 months

    This test identified the maximum distance (m) that each patient 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.

  3. 4x10 meter Shuttle Run test

    Time frame: 2 months

    This test measured the time (seconds) that each patient took to run forth and back a 10-meter track. Better performance is indicated by a shorter time.

  4. Timed up and down stairs test

    Time frame: 2 months

    This test measured the time (seconds) that each patient took to climb up and down a 14-step stair flight (each 20 cm in height). Better performance is indicated by a shorter time.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effects of Adaptive Variable-resistance Training on Chemotherapy-induced Sarcopenia, Fatigue, and Functional Restriction in Pediatric Survivors of Acute Lymphoblastic Leukemia: A Large-scale Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

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

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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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