Acute Lymphoblastic LeukemiaNCT06338020
Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia
A study testing Adaptive variable-resistance training and Standard physical therapy in people with Acute Lymphoblastic Leukemia, run by Cairo University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Adaptive variable-resistance training and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 29 Dec 2022to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Secondary cancers
- Neurodegenerative impairments affecting memory, attention, or executive functioning
- Neuro-musculoskeletal conditions are likely to impede the training.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Adaptive variable-resistance training, Standard physical therapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive variable-resistance trainingOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive-VRT | Experimental | Participants in this group received the adaptive variable-resistance training program in besides the standard physical therapy care. Receives: Other: Adaptive variable-resistance training |
| Standard Physical Therapy | Active comparator | Participants in this group received the standard exercise program. Receives: Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (4)
Fatigue
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.
Measured: 2 months
Six-minute walk test
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.
Measured: 2 months
4x10 meter Shuttle Run test
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.
Measured: 2 months
Timed up and down stairs test
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start29 Dec 2022
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, dual-arm, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K. Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338020
- Sponsor's protocol ID
- RHPT/0022/0042
- Status last verified
- Mar 2024
- First submitted
- 23 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39985582
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06338020
- Acronym / sponsor ID
- RHPT/0022/0042
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, dual-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adaptive-VRT | Experimental | Other: Adaptive variable-resistance trainingParticipants in this group received the adaptive variable-resistance training program in besides the standard physical therapy care. |
| Standard Physical Therapy | Active comparator | Other: Standard physical therapyParticipants in this group received the standard exercise program. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 12 and 18 years old
- Complete maintenance chemotherapy
- Secondary sarcopenia
- Normal cardiac structure and function
- Absence of lower limb deformities
Key exclusion criteria (3 listed)
- Secondary cancers
- Neurodegenerative impairments affecting memory, attention, or executive functioning
- Neuro-musculoskeletal conditions are likely to impede the training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive variable-resistance trainingThe 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. | Other | Adaptive-VRT |
| Standard physical therapyThe 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. | Other | Standard Physical Therapy |
Primary outcome
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.
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.
4 secondary outcomes
Fatigue
Time frame: 2 months
Six-minute walk test
Time frame: 2 months
4x10 meter Shuttle Run test
Time frame: 2 months
Timed up and down stairs test
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 39985582Elnaggar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K. Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive variable-resistance training and Standard physical therapy in people with Acute Lymphoblastic Leukemia, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh muscle thickness (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.