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NCT Number: NCT04617145

Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

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.

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Key information

Conditions

Acute Myeloid Leukemia in Remission

Age range

35 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Giza, Cairo Governorate, 002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aerobic Exercise

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Maximum oxygen consumption

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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