Quality of LifeNCT03147365
Effect of Different Exercises on Quality of Life of Leukemia Patients.
A study testing Aerobic exercises and Modified strength training in people with Quality of Life and Acute Lymphoblastic Leukemia, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial summary
To compare between modified strength training program and aerobic exercises on quality of life on children with Acute Lymphoblastic Leukemia. To compare between modified strength training program and aerobic exercises on functional capacity on children with Acute Lymphoblastic Leukemia. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Quality of Life, Acute Lymphoblastic Leukemia, Exercise
- What is being tested?
- Aerobic exercises and Modified strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2017to 5 Apr 2020
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range from8-12years.
- Children during 3rd phase( maintenance phase of the treatment). According San et al(2007) who found children with Acute Lymphoblastic Leukemia in maintenance phase of treatment can safely perform both aerobic and resistance training .
- Time elapsed since the start of the maintenance phase >20weeks.
- Children with muscle weakness due to chemotherapy.
- The height , weight and body mass index of the child will take on standard scale.
- preserved cardiac structure and function as assisted by echo-cardiogram.
- The children have ability to walk.
Who cannot join
- Children who have one or more of the following criteria will be excluded from the study:
- Receiving more intensive chemotherapy.
- Mental disabled.
- Sever cardiomyopathy (ejection fraction <40%, ECG will be used as a pretest as it might be a more sensitive tool to exclude angina pectoris).
- Low blood platelet levels (< 50.000 per µl).
- Marked anemia (hemoglobin < 8 g/dl).
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- Severe cachexia (i.e., weight mass loss > 35%).
- Pain in bone.
- Inability to walk.
- Sensory disturbance.
- Peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Training Versus Strength Exercises on Quality of Life and Functional Capacity on Children With Leukemia.
- To compare between modified strength training program and aerobic exercises on quality of life on children with Acute Lymphoblastic Leukemia.
- To compare between modified strength training program and aerobic exercises on functional capacity on children with Acute Lymphoblastic Leukemia.
Read the detailed description
This study will be done to determine any exercise from aerobic exercises or modified strength training program will be more effective on quality of life and functional capacity on children with Acute Lymphoblastic Leukemia .Acute Lymphoblastic Leukemia is wide spread in the world and the children with this disease are fragile so must know the most program effect.
- Conditions
- Quality of Life, Acute Lymphoblastic Leukemia, Exercise
- Being tested
- Aerobic exercises, Modified strength training
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercisesBehavioural
Aerobic exercises will do by using treadmill for children of study group A. it will consist of (max.incline15% - max. speed - heart rate grips and wireless chest strap - smooth virtual fitness trainer - smooth drop folding frame - impression shock absorption cushioning system).
Modified strength trainingBehavioural
Dumbbells will be used to conduct the modified strength training program for children of group B. This exercises included five exercises for the main muscle groups: bench press, leg press, seat row, leg extension and lat pull down.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Twenty five children who will not receive any physical therapy treatment. |
| Study group A | Experimental | Twenty five children who will receive physical therapy treatment which include aerobic exercises. Receives: Behavioral: Aerobic exercises |
| Study group B | Experimental | Twenty five children who will receive physical therapy treatment which include modified strength training program. Receives: Behavioral: Modified strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of quality of life
The pediatric quality of life inventory (PedsQL) is a modular approach to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions.
Measured: at week 20
Secondary outcomes (1)
Improvement of functional capacity
6 minute walk test is a test to measure functional capacity by using pulse oximeter to detect percentage of oxygen saturation at peripheral capillaries.
Measured: at week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start5 Mar 2017
- Primary completion27 Dec 2019
- Study completion5 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doaa M Khalifa, BSc, Principal investigator, Children's Cancer Hospital Egypt CCHE 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147365
- Sponsor's protocol ID
- CCHE-ALL003
- Status last verified
- Jan 2020
- First submitted
- 2 Apr 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Training Versus Strength Exercises on Quality of Life and Functional Capacity on Children With Leukemia.
- ClinicalTrials.gov ID
- NCT03147365
- Acronym / sponsor ID
- CCHE-ALL003
- Conditions
- Quality of Life, Acute Lymphoblastic Leukemia, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 10 May 2017 (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.
- To compare between modified strength training program and aerobic exercises on quality of life on children with Acute Lymphoblastic Leukemia.
- To compare between modified strength training program and aerobic exercises on functional capacity on children with Acute Lymphoblastic Leukemia.
Detailed description
This study will be done to determine any exercise from aerobic exercises or modified strength training program will be more effective on quality of life and functional capacity on children with Acute Lymphoblastic Leukemia .Acute Lymphoblastic Leukemia is wide spread in the world and the children with this disease are fragile so must know the most program effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Twenty five children who will not receive any physical therapy treatment. |
| Study group A | Experimental | Behavioral: Aerobic exercisesTwenty five children who will receive physical therapy treatment which include aerobic exercises. |
| Study group B | Experimental | Behavioral: Modified strength trainingTwenty five children who will receive physical therapy treatment which include modified strength training program. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age range from8-12years.
- Children during 3rd phase( maintenance phase of the treatment). According San et al(2007) who found children with Acute Lymphoblastic Leukemia in maintenance phase of treatment can safely perform both aerobic and resistance training .
- Time elapsed since the start of the maintenance phase >20weeks.
- Children with muscle weakness due to chemotherapy.
- The height , weight and body mass index of the child will take on standard scale.
Key exclusion criteria (11 listed)
- Receiving more intensive chemotherapy.
- Mental disabled.
- Sever cardiomyopathy (ejection fraction <40%, ECG will be used as a pretest as it might be a more sensitive tool to exclude angina pectoris).
- Low blood platelet levels (< 50.000 per µl).
- Marked anemia (hemoglobin < 8 g/dl).
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 |
|---|---|---|
| Aerobic exercisesAerobic exercises will do by using treadmill for children of study group A. it will consist of (max.incline15% - max. speed - heart rate grips and wireless chest strap - smooth virtual fitness trainer - smooth drop folding frame - impression shock absorption cushioning system). | Behavioural | Study group A |
| Modified strength trainingDumbbells will be used to conduct the modified strength training program for children of group B. This exercises included five exercises for the main muscle groups: bench press, leg press, seat row, leg extension and lat pull down. | Behavioural | Study group B |
Primary outcome
Improvement of quality of life
Time frame: at week 20
The pediatric quality of life inventory (PedsQL) is a modular approach to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions.
1 secondary outcome
Improvement of functional capacity
Time frame: at week 20
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 21 Jul 2020.
- 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.
Doaa M Khalifa, BSc principal investigator
Children's Cancer Hospital Egypt CCHE 57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercises and Modified strength training in people with Quality of Life and Acute Lymphoblastic Leukemia, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
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 7 inclusion and 11 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 21 Jul 2020. 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 Egypt. 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?
Improvement of quality of life (time frame: at week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2020.