Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

Acute Myeloid Leukemia in Remission Clinical Trial

Official title:

Impact of Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia Survivors; a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617145
• Other study ID #: MA201918
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Myeloid Leukemia in Remission
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Aerobic 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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	It is performed before and after the study(8 weeks interval) for both groups
Primary	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	It is performed before and after the study(8 weeks interval) for both groups
Primary	Vital capacity	was measured by using electronic spirometry used to conduct ventilatory function testing	It is performed before and after the study(8 weeks interval) for both groups
Secondary	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)	It is performed before and after the study(8 weeks interval) for both groups
Secondary	Fatigue assessment scale (FAS)	FAS is a 10-item scale evaluating symptoms of chronic fatigue	It is performed before and after the study(8 weeks interval) for both groups
Secondary	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	It is performed before and after the study(8 weeks interval) for both groups