Acute Myeloid Leukemia in RemissionNCT04617145
Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia
A study testing Aerobic exercise in people with Acute Myeloid Leukemia in Remission, run by Cairo University at 1 site in Egypt.
Trial summary
Sixty patients with AML from both sexes aged from 35-45 years were selected from hematology department in Nasser Institute Hospital where the study was conducted. Patients were randomly assigned into two groups equal in number. Read more about this study
- Who is it for?
- Ages 35 to 45 years
- Conditions the study is for
- Acute Myeloid Leukemia in Remission
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Oct 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 35 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute myeloid leukemia survivors from both sexes
- Their age ranged from 35-45 years.
- Patients were in remission stage contains less than 5% blast cells in their bone marrow, absolute neutrophil count (>1000/microL), platelet count(>100,000/microL),and independence from red cell transfusion.
Who cannot join
- Extramedullary leukemia
- musculoskeletal deformities
- severe anemia (hemoglobin less than 8g/dl).
- Autoimmune thrombocytopenia (platelets less than 10000UL or leucocytes count more than 3000UL).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia Survivors; a Comparative Study
Sixty patients with AML from both sexes aged from 35-45 years were selected from hematology department in Nasser Institute Hospital where the study was conducted. Patients were randomly assigned into two groups equal in number. Group (A) underwent aerobic exercises in the form of cycling with 50-60% of maximum heart rate. Group (B) underwent resistive training conducted in the form of a series of exercises using free weights, and dumbles. Sessions were conducted three times /week for eight weeks. Six minutes' walk test (6MWT), 10 repetitions maximum test (10 RM), ventilatory function test, fatigue and quality of life (QOL) scales were used to assess functional capacity in both groups.
Read the detailed description
Aerobic Ex Group: Included 30 patients who underwent aerobic training with 50 %-60% of maximum heart rate in the form of cycling by Bicycle ergometer for eight weeks, three sessions/week.
Resistive Ex Group: Included 30 patients who underwent a resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. Sessions were conducted three sessions/week for eight weeks.
- Conditions
- Acute Myeloid Leukemia in Remission
- Being tested
- Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Also called Resistive exercise
resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. Sessions were conducted three sessions/week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Active comparator | Included 30 patients who underwent aerobic training with 50 %-60% of maximum heart rate in the form of cycling by Bicycle ergometer for eight weeks, three sessions/week. Receives: Other: Aerobic exercise |
| Resistive exercise group | Active comparator | Included 30 patients who underwent a resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Sessions were conducted three sessions/week for eight weeks. Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minutes walking Distance
which used to measure the distance the patient was able to walk over a total of six minutes According to American thorax society guidelines; patients were instructed to walk as fast as long as possible , in a 30 meters obstacle free corridor limited by turnaround cones and distance was calculated
Measured: It is performed before and after the study(8 weeks interval) for both groups
10 repetition maximum test
which the greatest amount of weight a person can lift number of times. The amount of weight that can be lifted exactly 10 times is 10 RM
Measured: It is performed before and after the study(8 weeks interval) for both groups
Vital capacity
was measured by using electronic spirometry used to conduct ventilatory function testing
Measured: It is performed before and after the study(8 weeks interval) for both groups
Secondary outcomes (3)
Maximum oxygen consumption
Results of (6MWT) was used to calculate Vo2 max by using Cahalin equation as follows; Vo2 max = 0.03x distance in meters +3.98, in which distance is obtained from (6MWT)
Measured: It is performed before and after the study(8 weeks interval) for both groups
Fatigue assessment scale (FAS)
FAS is a 10-item scale evaluating symptoms of chronic fatigue
Measured: It is performed before and after the study(8 weeks interval) for both groups
Quality of life questionnaire (QOL)
was used to evaluate the quality of life before and after training for both groups.The Quality of Life Instrument (CANCER PATIENT/CANCER SURVIVOR VERSION) is a forty one-item ordinal scale. The scoring should be based on a scale of 0 = worst outcome to 10 = best outcome
Measured: It is performed before and after the study(8 weeks interval) for both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Apr 2018
- Primary completion2 Jun 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia in RemissionStudies 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
- parallel randomized single blinded study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617145
- Sponsor's protocol ID
- MA201918
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 5 Nov 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia Survivors; a Comparative Study
- ClinicalTrials.gov ID
- NCT04617145
- Acronym / sponsor ID
- MA201918
- Conditions
- Acute Myeloid Leukemia in Remission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 5 Nov 2020 (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.
Sixty patients with AML from both sexes aged from 35-45 years were selected from hematology department in Nasser Institute Hospital where the study was conducted. Patients were randomly assigned into two groups equal in number. Group (A) underwent aerobic exercises in the form of cycling with 50-60% of maximum heart rate. Group (B) underwent resistive training conducted in the form of a series of exercises using free weights, and dumbles. Sessions were conducted three times /week for eight weeks. Six minutes' walk test (6MWT), 10 repetitions maximum test (10 RM), ventilatory function test, fatigue and quality of life (QOL) scales were used to assess functional capacity in both groups.
Detailed description
Aerobic Ex Group: Included 30 patients who underwent aerobic training with 50 %-60% of maximum heart rate in the form of cycling by Bicycle ergometer for eight weeks, three sessions/week.
Resistive Ex Group: Included 30 patients who underwent a resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. Sessions were conducted three sessions/week for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel randomized single blinded study
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Active comparator | Other: Aerobic exerciseIncluded 30 patients who underwent aerobic training with 50 %-60% of maximum heart rate in the form of cycling by Bicycle ergometer for eight weeks, three sessions/week. |
| Resistive exercise group | Active comparator | Other: Aerobic exerciseIncluded 30 patients who underwent a resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Sessions were conducted three sessions/week for eight weeks. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Acute myeloid leukemia survivors from both sexes
- Their age ranged from 35-45 years.
- Patients were in remission stage contains less than 5% blast cells in their bone marrow, absolute neutrophil count (>1000/microL), platelet count(>100,000/microL),and independence from red cell transfusion.
Key exclusion criteria (4 listed)
- Extramedullary leukemia
- musculoskeletal deformities
- severe anemia (hemoglobin less than 8g/dl).
- Autoimmune thrombocytopenia (platelets less than 10000UL or leucocytes count more than 3000UL).
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 exerciseAlso: Resistive exerciseresistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. Sessions were conducted three sessions/week for eight weeks. | Other | Aerobic exercise group, Resistive exercise group |
Primary outcome
Six minutes walking Distance
Time frame: It is performed before and after the study(8 weeks interval) for both groups
which used to measure the distance the patient was able to walk over a total of six minutes According to American thorax society guidelines; patients were instructed to walk as fast as long as possible , in a 30 meters obstacle free corridor limited by turnaround cones and distance was calculated
10 repetition maximum test
Time frame: It is performed before and after the study(8 weeks interval) for both groups
which the greatest amount of weight a person can lift number of times. The amount of weight that can be lifted exactly 10 times is 10 RM
Vital capacity
Time frame: It is performed before and after the study(8 weeks interval) for both groups
was measured by using electronic spirometry used to conduct ventilatory function testing
3 secondary outcomes
Maximum oxygen consumption
Time frame: It is performed before and after the study(8 weeks interval) for both groups
Fatigue assessment scale (FAS)
Time frame: It is performed before and after the study(8 weeks interval) for both groups
Quality of life questionnaire (QOL)
Time frame: It is performed before and after the study(8 weeks interval) for both groups
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 5 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 exercise in people with Acute Myeloid Leukemia in Remission, run by Cairo University 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 3 inclusion and 4 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 5 Nov 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?
Six minutes walking Distance (time frame: It is performed before and after the study(8 weeks interval) for both groups). The study lists 3 primary outcomes in all. 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 5 Nov 2020.