Clinical trial NCT04617145: Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia
Official title: Impact of Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia Survivors; a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia in Remission
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel randomized single blinded study
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Extramedullary leukemia
* musculoskeletal deformities
* severe anemia (hemoglobin less than 8g/dl).
* Autoimmune thrombocytopenia (platelets less than 10000UL or leucocytes count more than 3000UL).

Primary outcomes:
measure: Six minutes walking Distance
timeFrame: It is performed before and after the study(8 weeks interval) for both groups
measure: 10 repetition maximum test
timeFrame: It is performed before and after the study(8 weeks interval) for both groups
measure: Vital capacity
timeFrame: It is performed before and after the study(8 weeks interval) for both groups
Secondary outcomes:
measure: Maximum oxygen consumption
timeFrame: It is performed before and after the study(8 weeks interval) for both groups
measure: Fatigue assessment scale (FAS)
timeFrame: It is performed before and after the study(8 weeks interval) for both groups
measure: Quality of life questionnaire (QOL)
timeFrame: It is performed before and after the study(8 weeks interval) for both groups
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
state: Cairo
Study officials:
References: