Back to resultsRESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Treadmill
resisted exercises
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
-
The subject selection will be according to the following criteria:
- Age range from 30-60 years.
- Females post mastectomy only will participate in the study.
- All patients undergoing adjuvant chemotherapy and have cancer related fatigue and decreased immunity.
- All patients enrolled to the study will have their informed consent.
Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
- Age more than 60 years or less than 30 years.
- Another concurrent malignant disease.
- Subjects suffering from any condition for which resistance or aerobic exercises contraindicated as metastasis, sever osteoporosis and cardiac diseases.
Sites / Locations
- Medical research instituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
resistance exercises
aerobic exercise
Arm Description
Resistance exercises will be involved in this technique are for upper and lower limb (Exercise program including shoulder flexion, abduction and horizontal adduction, elbow extension and flexion, calf raise, leg extension and squatting) three times daily and five times per week. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first and second weeks, progressing to two circuits, using 60% of their 1RM and repeat 10 times for the third and fourth weeks. In fifth and sixth weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last 6 weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. Time of exercise equal time of rest
Aerobic training (AT) program of submaximal intensity will include a 45-minute session five times per week under the supervision of the researcher. Aerobic exercise will consist of three phases: warm-up, training and cool down. At the beginning of exercise session, subjects will have a ten-minute warm-up. The warm up protocol will be slowly running on treadmill. Then, the warm-up phase will be followed by the training phase. At baseline, the training phase will be commenced with two 30- minute running on treadmill at 50% of their maximal heart rate (MHR) in the first week and increased to 70% MHR by the final week of training. By the end of exercise session, subjects will have a five-minute cool down. The cool down protocol will be slowly running on treadmill. The vital measures such as HR and blood pressure was monitored before patient left the department (Dimeo et al.,2016), maximum heart rate will be calculated using the formula: (HR Max =220- age)
Outcomes
Primary Outcome Measures
Fatigue assessment scale
The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases
Fatigue assessment scale
The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases
Fatigue assessment scale
The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases
Hemoglobin level test for fatigue assessment
Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen
Hemoglobin level test for fatigue assessment
Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen
Hemoglobin level test for fatigue assessment
Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen
White blood cells count test for immunity assessment
White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system
White blood cells count test for immunity assessment
White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system
White blood cells count test for immunity assessment
White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04656457
Brief Title
RESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients
Official Title
Resistance Versus Aerobic Exercises On Cancer Related Fatigue And Immunity In Breast Cancer Patients Undergoing Adjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
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
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate which is more effective resistance or aerobic exercises on cancer related fatigue and immunity in breast cancer patients undergoing adjuvant chemotherapy.
Detailed Description
The problem of cancer related fatigue and decreased immunity, as a result of treatment with adjuvant chemotherapy in breast cancer patients is not well known.
Fatigue and decreased immunity have a negative impact on work, social relationships, mood, and daily activities and cause significant impairment in overall quality of life, Furthermore the need of this study is developed from the lack of information in the published studies about the effect of the treatment with chemotherapy among breast cancer patients on inducing fatigue and decreasing immunity and the effect of resistance and aerobic exercises on improving these changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
resistance exercises
Arm Type
Active Comparator
Arm Description
Resistance exercises will be involved in this technique are for upper and lower limb (Exercise program including shoulder flexion, abduction and horizontal adduction, elbow extension and flexion, calf raise, leg extension and squatting) three times daily and five times per week. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first and second weeks, progressing to two circuits, using 60% of their 1RM and repeat 10 times for the third and fourth weeks. In fifth and sixth weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last 6 weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. Time of exercise equal time of rest
Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Description
Aerobic training (AT) program of submaximal intensity will include a 45-minute session five times per week under the supervision of the researcher. Aerobic exercise will consist of three phases: warm-up, training and cool down. At the beginning of exercise session, subjects will have a ten-minute warm-up. The warm up protocol will be slowly running on treadmill. Then, the warm-up phase will be followed by the training phase. At baseline, the training phase will be commenced with two 30- minute running on treadmill at 50% of their maximal heart rate (MHR) in the first week and increased to 70% MHR by the final week of training. By the end of exercise session, subjects will have a five-minute cool down. The cool down protocol will be slowly running on treadmill. The vital measures such as HR and blood pressure was monitored before patient left the department (Dimeo et al.,2016), maximum heart rate will be calculated using the formula: (HR Max =220- age)
Intervention Type
Device
Intervention Name(s)
Treadmill
Intervention Description
Treadmill is not used to harness power, but as exercise machines for running or walking in one place. Rather than the user powering the mill, the machine provides a moving platform with a wide conveyor belt driven by an electric motor or a flywheel. The belt moves to the rear, requiring the user to walk or run at a speed matching that of the belt. The rate at which the belt moves is the rate of walking or running. Thus, the speed of running may be controlled and measured
Intervention Type
Other
Intervention Name(s)
resisted exercises
Intervention Description
Resistance exercises will be involved in this technique are for upper and lower limb (Exercise program including shoulder flexion, abduction and horizontal adduction, elbow extension and flexion, calf raise, leg extension and squatting)
Primary Outcome Measure Information:
Title
Fatigue assessment scale
Description
The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases
Time Frame
The evaluation will be conducted during before the cycles
Title
Fatigue assessment scale
Description
The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases
Time Frame
The evaluation will be conducted during one and half month
Title
Fatigue assessment scale
Description
The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases
Time Frame
The evaluation will be conducted three months later
Title
Hemoglobin level test for fatigue assessment
Description
Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen
Time Frame
he evaluation will be conducted before the cycles
Title
Hemoglobin level test for fatigue assessment
Description
Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen
Time Frame
he evaluation will be conducted during one and half month
Title
Hemoglobin level test for fatigue assessment
Description
Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen
Time Frame
he evaluation will be conducted three months later
Title
White blood cells count test for immunity assessment
Description
White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system
Time Frame
he evaluation will be conducted before the cycles
Title
White blood cells count test for immunity assessment
Description
White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system
Time Frame
he evaluation will be conducted during one and half month
Title
White blood cells count test for immunity assessment
Description
White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system
Time Frame
he evaluation will be conducted three months later
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
The subject selection will be according to the following criteria:
Age range from 30-60 years.
Females post mastectomy only will participate in the study.
All patients undergoing adjuvant chemotherapy and have cancer related fatigue and decreased immunity.
All patients enrolled to the study will have their informed consent.
Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
Age more than 60 years or less than 30 years.
Another concurrent malignant disease.
Subjects suffering from any condition for which resistance or aerobic exercises contraindicated as metastasis, sever osteoporosis and cardiac diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lamiaa sa tolba, ASS.lecturer
Phone
01007215433
Email
lamiaa.said@pua.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal mo abdel baky, Professor
Phone
01124663339
Email
amalabaky@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal mo abdel baky, professor
Organizational Affiliation
faculty of physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
Medical research institute
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lamiaa S Saleh, Master
Phone
01007215433
Email
Lamiaa.said@pua.edu.eg
12. IPD Sharing Statement
Learn more about this trial
RESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients
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