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

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ClinicalTrials.gov Identifier: NCT05970250
Recruitment Status : Completed
First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Eman Mahrous Abdel-Hamed Ahmed Elgendy, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis Breast Cancer Other: Whole body vibration group Other: Weight bearing exercises Drug: vitamin D supplements and calcium Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy
Actual Study Start Date : January 20, 2022
Actual Primary Completion Date : April 20, 2022
Actual Study Completion Date : July 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Other: 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.

Drug: vitamin D supplements and calcium
vitamin D supplements and calcium
Experimental: 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).
 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.

Drug: vitamin D supplements and calcium
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.
 Drug: vitamin D supplements and calcium
vitamin D supplements and calcium


Outcome Measures
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Primary Outcome Measures :
  1. Assessing the change in bone mineral density [ Time Frame: at baseline and after 2 months of intervention ]
    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 .


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05970250


Locations
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Egypt
Outpatient clinic faculty of physical therapy cairo university
Dokki, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Eman Elgendy Cairo University
More Information
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Responsible Party: Eman Mahrous Abdel-Hamed Ahmed Elgendy, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT05970250    
Other Study ID Numbers: Eman Mahrous Abdel-Hamed Ahmed
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Osteoporosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Vitamin D
Calcium
Vitamins
Micronutrients
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents