Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia in Remission
• Intervention / Treatment: Other: Aerobic exercise

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Giza, Cairo, Egypt, 002
      • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Aerobic exercise 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.	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.; Other Names: Resistive exercise
ACTIVE_COMPARATOR: Resistive exercise 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. Sessions were conducted three sessions/week for eight weeks.	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.; Other Names: Resistive exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): June 2, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: MA201918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No