RESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients

NCT ID: NCT04656457

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2021-04-01

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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resistance exercises

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

Group Type ACTIVE_COMPARATOR

resisted exercises

Intervention Type OTHER

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)

aerobic exercise

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)

Group Type ACTIVE_COMPARATOR

Treadmill

Intervention Type DEVICE

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

Interventions

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Treadmill

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 DEVICE

resisted exercises

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

The subject selection will be according to the following criteria:

1. Age range from 30-60 years.
2. Females post mastectomy only will participate in the study.
3. All patients undergoing adjuvant chemotherapy and have cancer related fatigue and decreased immunity.
4. 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:

1. Age more than 60 years or less than 30 years.
2. Another concurrent malignant disease.
3. Subjects suffering from any condition for which resistance or aerobic exercises contraindicated as metastasis, sever osteoporosis and cardiac diseases.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Lamiaa said tolba saleh

ASSISSTANT LECTURER

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal mo abdel baky, professor

Role: STUDY_DIRECTOR

faculty of physical therapy

Locations

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Medical research institute

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Lamiaa sa tolba, ASS.lecturer

Role: CONTACT

01007215433

Amal mo abdel baky, Professor

Role: CONTACT

01124663339

Facility Contacts

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Lamiaa S Saleh, Master

Role: primary

01007215433

Other Identifiers

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P.T.REC/012/002968

Identifier Type: -

Identifier Source: org_study_id

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