Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338020
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-23
Brief Title:
Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 OncologyHematology 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 flexorextensor 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 degreessecond 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 manualmechanical strength training and moderate-intensity aerobic exercises on a treadmill or bicycle ergometer
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 flexorextensor 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 degreessecond 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 manualmechanical strength training and moderate-intensity aerobic exercises on a treadmill or bicycle ergometer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None