Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy

NCT ID: NCT05970250

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2022-07-20

Brief Summary

Chemotherapy can damage bone marrow and therefore impair the production of white blood cells, platelets and red blood cells with the resulting anemia and osteoporosis.

Detailed Description

Purposes of this study were:

1. To determine the therapeutic efficacy of the whole-body vibration (WBV) in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

2. To determine the therapeutic efficacy of the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

3. To gain knowledge about the whole-body vibration (WBV) and the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

4. To share in designing an ideal protocol for the treatment of the osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

Conditions

Osteoporosis; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Whole body vibration group

In this group (the first study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received the whole body vibration, 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).

Group Type: EXPERIMENTAL

Whole body vibration group

Intervention Type: OTHER

Whole body vibration apparatus (model Power plate -my5tm, made in United States) with frequency 30 - 40 Hz was used for the whole body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum.

vitamin D supplements and calcium

Intervention Type: DRUG

vitamin D supplements and calcium

Weight bearing exercises group

In this group (the second study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received aerobic exercise on treadmill as form of weight bearing exercise 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).

Group Type: EXPERIMENTAL

Weight bearing exercises

Intervention Type: OTHER

Electronic treadmill Kettler- marathon model No 7899-800, made in Germany (as form of weight bearing exercises), which was adjusted to the subject's comfortable walking speed. Generally, during the treadmill training, its speed and inclination are electronically adjusted, and it is also provided with a control panel to display the exercise parameters. It allows for the comfortable running without joint or back pains through a perfect combination between aluminium-pertinax running deck, shock absorbers and overall shock-damping design.

vitamin D supplements and calcium

Intervention Type: DRUG

vitamin D supplements and calcium

drug therapy group

In this group (control group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received only drug therapy (vitamin D supplements and calcium. Measurements were conducted before starting the treatment as a first record, at end of the second month of treatment as second record and make follow up after 3 months as final record.

Group Type: OTHER

vitamin D supplements and calcium

Intervention Type: DRUG

vitamin D supplements and calcium

Interventions

Whole body vibration group

Whole body vibration apparatus (model Power plate -my5tm, made in United States) with frequency 30 - 40 Hz was used for the whole body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum.

Intervention Type: OTHER

Weight bearing exercises

Electronic treadmill Kettler- marathon model No 7899-800, made in Germany (as form of weight bearing exercises), which was adjusted to the subject's comfortable walking speed. Generally, during the treadmill training, its speed and inclination are electronically adjusted, and it is also provided with a control panel to display the exercise parameters. It allows for the comfortable running without joint or back pains through a perfect combination between aluminium-pertinax running deck, shock absorbers and overall shock-damping design.

Intervention Type: OTHER

vitamin D supplements and calcium

vitamin D supplements and calcium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis.
• Their age ranges from 35-55 years old.
• All patients will have the same medical and nursing care.
• All the patients will receive a good explanation of treatment and measurement device.
• They are neurologically free.

Exclusion Criteria

Patients will be excluded from this study for any of the following causes:

• Uncooperative patients.
• Instability of patient's medical condition.
• Association of another medical problem.
• Patients who have diabetes.
• Patients who have history of medical chronic relevant diseases.
• Patients who have acute or chronic hepatitis.
• Patients who have pacemaker.
• Patients who have genitourinary infections.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eman Mahrous Abdel-Hamed Ahmed Elgendy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Elgendy

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic faculty of physical therapy cairo university

Dokki, , Egypt

Countries

Egypt

Other Identifiers

Eman Mahrous Abdel-Hamed Ahmed

Identifier Type: -

Identifier Source: org_study_id