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

Primary Purpose

Osteoporosis, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Whole body vibration group
Weight bearing exercises
vitamin D supplements and calcium
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Outpatient clinic faculty of physical therapy cairo university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Whole body vibration group

Weight bearing exercises group

drug therapy group

Arm Description

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).

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).

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.

Outcomes

Primary Outcome Measures

Assessing the change in bone mineral density
By using DEXA (dual-energy X-ray absorptiometry): Dual-energy X-ray absorptiometry (DEXA) is a clinically proven method of measuring bone mineral density (BMD) in the lumbar spine, proximal femur, forearm, and whole body. It is used primarily in the diagnosis and management of osteoporosis and other disease states characterized by abnormal BMD, as well as to monitor response to therapy for these conditions .

Secondary Outcome Measures

Full Information

First Posted
July 24, 2023
Last Updated
July 24, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05970250
Brief Title
Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy
Official Title
Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

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
Yes

5. Study Description

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: 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. To determine the therapeutic efficacy of the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months. 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. To share in designing an ideal protocol for the treatment of the osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration group
Arm Type
Experimental
Arm Description
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).
Arm Title
Weight bearing exercises group
Arm Type
Experimental
Arm Description
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).
Arm Title
drug therapy group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Whole body vibration group
Intervention Description
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
Intervention Name(s)
Weight bearing exercises
Intervention Description
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
Drug
Intervention Name(s)
vitamin D supplements and calcium
Intervention Description
vitamin D supplements and calcium
Primary Outcome Measure Information:
Title
Assessing the change in bone mineral density
Description
By using DEXA (dual-energy X-ray absorptiometry): Dual-energy X-ray absorptiometry (DEXA) is a clinically proven method of measuring bone mineral density (BMD) in the lumbar spine, proximal femur, forearm, and whole body. It is used primarily in the diagnosis and management of osteoporosis and other disease states characterized by abnormal BMD, as well as to monitor response to therapy for these conditions .
Time Frame
at baseline and after 2 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Elgendy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy cairo university
City
Dokki
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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