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Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia in Remission

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia in Remission

Eligibility Criteria

35 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aerobic exercise group

Resistive exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
Vital capacity
was measured by using electronic spirometry used to conduct ventilatory function testing

Secondary Outcome Measures

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)
Fatigue assessment scale (FAS)
FAS is a 10-item scale evaluating symptoms of chronic fatigue
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

Full Information

First Posted
October 30, 2020
Last Updated
October 30, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04617145
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 2, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia in Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel randomized single blinded study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Resistive exercise group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Other Intervention Name(s)
Resistive exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six minutes walking Distance
Description
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
Time Frame
It is performed before and after the study(8 weeks interval) for both groups
Title
10 repetition maximum test
Description
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
Time Frame
It is performed before and after the study(8 weeks interval) for both groups
Title
Vital capacity
Description
was measured by using electronic spirometry used to conduct ventilatory function testing
Time Frame
It is performed before and after the study(8 weeks interval) for both groups
Secondary Outcome Measure Information:
Title
Maximum oxygen consumption
Description
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)
Time Frame
It is performed before and after the study(8 weeks interval) for both groups
Title
Fatigue assessment scale (FAS)
Description
FAS is a 10-item scale evaluating symptoms of chronic fatigue
Time Frame
It is performed before and after the study(8 weeks interval) for both groups
Title
Quality of life questionnaire (QOL)
Description
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
Time Frame
It is performed before and after the study(8 weeks interval) for both groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

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