Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04617145
Collaborator
(none)
60
1
2
30
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic exercise
N/A

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
parallel randomized single blinded studyparallel randomized single blinded study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia Survivors; a Comparative Study
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Jun 2, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Six minutes walking Distance [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

    2. 10 repetition maximum test [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

    3. Vital capacity [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

    Secondary Outcome Measures

    1. Maximum oxygen consumption [It is performed before and after the study(8 weeks interval) for both groups]

      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)

    2. Fatigue assessment scale (FAS) [It is performed before and after the study(8 weeks interval) for both groups]

      FAS is a 10-item scale evaluating symptoms of chronic fatigue

    3. Quality of life questionnaire (QOL) [It is performed before and after the study(8 weeks interval) for both groups]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Physical Therapy Giza Cairo Egypt 002

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heba Ahmed Ali Abdeen, Assistant Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04617145
    Other Study ID Numbers:
    • MA201918
    First Posted:
    Nov 5, 2020
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 5, 2020