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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05970250
Other study ID # Eman Mahrous Abdel-Hamed Ahmed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date July 20, 2022

Study information

Verified date July 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 20, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers No
Gender All
Age group 35 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Egypt Outpatient clinic faculty of physical therapy cairo university Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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