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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02876627
Other study ID # 201527904IR
Secondary ID
Status Completed
Phase Phase 1
First received August 15, 2016
Last updated August 18, 2016
Start date February 2015
Est. completion date April 2016

Study information

Verified date August 2016
Source University of Isfahan
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

Introduction: The purpose of this study was to determine the effect of twelve weeks of aerobic exercise program on erythrocyte levels in women with breast cancer after chemotherapy.

Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged between 47-65 years) volunteered for this study, and then randomly selected an exercise (n = 15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve, while the control group were followed. Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis of data, repeated-measures analysis of variance (ANOVA) was used.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2016
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 47 Years to 65 Years
Eligibility Inclusion Criteria:

women with breast cancer , who can do a physical, physiological and psychological test; and did not have exercise limitations due to neuromuscular and/or musculoskeletal disease; did not have any health problems that prevented maximum effort on the treadmill test.

Exclusion Criteria:

women under erythropoietin treatments, uncontrolled cardiovascular or pulmonary diseases, uncontrolled arrhythmias, orthopedic conditions that would limit exercise participation, refusal for randomization, or participation in aerobic exercise training within 3 months before beginning the study.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise training
twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Isfahan

Outcome

Type Measure Description Time frame Safety issue
Primary effect of exercise on CBC parameters (measured by ELISA methods) up to 12 weeks No
Secondary effect of exercise on peak oxygen consumption, measured by vo2 max test up to 12 weeks No
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