Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2022
CompletedFirst Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedAugust 1, 2023
July 1, 2023
3 months
July 24, 2023
July 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 .
at baseline and after 2 months of intervention
Study Arms (3)
Whole body vibration group
EXPERIMENTALIn 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).
Weight bearing exercises group
EXPERIMENTALIn 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).
drug therapy group
OTHERIn 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Outpatient clinic faculty of physical therapy cairo university
Dokki, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eman Elgendy
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 1, 2023
Study Start
January 20, 2022
Primary Completion
April 20, 2022
Study Completion
July 20, 2022
Last Updated
August 1, 2023
Record last verified: 2023-07