Breast CancerNCT04656457
RESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients
A study testing Treadmill and resisted exercises in people with Breast Cancer, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Treadmill and resisted exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- -
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Medical research institute
Alexandria
Lamiaa S Saleh, Master, 01007215433, Lamiaa.said@pua.edu.eg
About this study
Official title: Resistance Versus Aerobic Exercises On Cancer Related Fatigue And Immunity In Breast Cancer Patients Undergoing Adjuvant Chemotherapy
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Treadmill, resisted exercises
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmillDevice
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
resisted exercisesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| resistance exercises | Active comparator | 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 Receives: Other: resisted exercises |
| aerobic exercise | Active comparator | 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) Receives: Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The evaluation will be conducted during before the cycles
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
Measured: The evaluation will be conducted during one and half month
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
Measured: The evaluation will be conducted three months later
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
Measured: he evaluation will be conducted before the cycles
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
Measured: he evaluation will be conducted during one and half month
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
Measured: he evaluation will be conducted three months later
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
Measured: he evaluation will be conducted before the cycles
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
Measured: he evaluation will be conducted during one and half month
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
Measured: he evaluation will be conducted three months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start12 Dec 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa said tolba saleh, Cairo University
- Investigators
- Amal mo abdel baky, professor, Study director, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656457
- Sponsor's protocol ID
- P.T.REC/012/002968
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Versus Aerobic Exercises On Cancer Related Fatigue And Immunity In Breast Cancer Patients Undergoing Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04656457
- Acronym / sponsor ID
- P.T.REC/012/002968
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance exercises | Active comparator | Other: resisted exercisesResistance 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 exercise | Active comparator | Device: TreadmillAerobic 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) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- -
- 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.
Key exclusion criteria (4 listed)
- The potential participants will be excluded if they meet one of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreadmillTreadmill 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 | Device | aerobic exercise |
| resisted exercisesResistance 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) | Other | resistance exercises |
Primary outcome
Fatigue assessment scale
Time frame: The evaluation will be conducted during before the cycles
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
Time frame: The evaluation will be conducted during one and half month
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
Time frame: The evaluation will be conducted three months later
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
Time frame: he evaluation will be conducted before the cycles
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
Time frame: he evaluation will be conducted during one and half month
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
Time frame: he evaluation will be conducted three months later
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
Time frame: he evaluation will be conducted before the cycles
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
Time frame: he evaluation will be conducted during one and half month
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
Time frame: he evaluation will be conducted three months later
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal mo abdel baky, professor study director
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill and resisted exercises in people with Breast Cancer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lamiaa sa tolba, ASS.lecturer (01007215433, lamiaa.said@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue assessment scale (time frame: The evaluation will be conducted during before the cycles). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.