Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

NCT04617145 | Completed DMC

• 1 other identifier: MA201918
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia in Remission

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Maximum oxygen consumption

  It is performed before and after the study(8 weeks interval) for both groups

• Fatigue assessment scale (FAS)

  It is performed before and after the study(8 weeks interval) for both groups

• Quality of life questionnaire (QOL)

  It is performed before and after the study(8 weeks interval) for both groups

Study Arms (2)

Aerobic exercise group

ACTIVE COMPARATOR

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 exercise group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Resistive exercise

Aerobic exercise group; Resistive exercise group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Extramedullary leukemia
• musculoskeletal deformities
• severe anemia (hemoglobin less than 8g/dl).
• Autoimmune thrombocytopenia (platelets less than 10000UL or leucocytes count more than 3000UL).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: parallel randomized single blinded study

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: April 1, 2018
• Primary Completion: June 2, 2020
• Study Completion: October 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)