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Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis

Primary Purpose

Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

All participants had undergone thyroidectomy since 6 months and had cognitive and educational level enough to understand the requirements of the study

Exclusion Criteria:

All Patients with malignancies or receiving radiotherapy or chemotherapy, skin diseases, deep venous thrombosis or venous insufficiency, sensory impairment, renal failure, recent therapy with immunosuppressant or anticonvulsants, psychological problems or alcoholic drinkers were excluded from this study.

Sites / Locations

Marwa Eid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Magnetic Therapy Group

Exercise group

Combined Magnetic Therapy and Exercise Therapy group

Arm Description

patients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks

patients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks

patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks

Outcomes

Primary Outcome Measures

Osteoporosis changes

BMD by DEXA on each group

Secondary Outcome Measures

Full Information

NCT ID

NCT04488328

First Posted

July 17, 2020

Last Updated

July 22, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04488328

Brief Title

Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis

Official Title

Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

May 10, 2018 (Actual)

Primary Completion Date

May 5, 2019 (Actual)

Study Completion Date

September 20, 2019 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Objectives; This study was conducted to investigate the effect of pulsed magnetic therapy and aerobic exercise on post thyroidectomy osteoporosis. Methods; Forty-five female patients, age ranged from 40 to 50 years old with osteoporotic changes in hip and pelvic region post thyroidectomy, were included in this study. They were selected from Endocrinology private clinics. They were assigned randomly into three groups, equal in number. Magnetic Therapy Group (group A); patients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks (3 sessions/ week). Exercise group(group B); patients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks (3 sessions/week). Combined Magnetic Therapy and Exercise Therapy group (group C): patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks. Evaluation of the three groups was performed at baseline and after 12 weeks of treatment by dual energy x-ray absorptiometry (DEXA).

6. Conditions and Keywords

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

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Magnetic Therapy Group

Arm Type

Experimental

Arm Description

patients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks

Arm Title

Exercise group

Arm Type

Experimental

Arm Description

patients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks

Arm Title

Combined Magnetic Therapy and Exercise Therapy group

Arm Type

Experimental

Arm Description

patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks

Intervention Type

Other

Intervention Name(s)

patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks

Intervention Description

patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks(3 sessions/ week)

Primary Outcome Measure Information:

Title

Osteoporosis changes

Description

BMD by DEXA on each group

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All participants had undergone thyroidectomy since 6 months and had cognitive and educational level enough to understand the requirements of the study Exclusion Criteria: All Patients with malignancies or receiving radiotherapy or chemotherapy, skin diseases, deep venous thrombosis or venous insufficiency, sensory impairment, renal failure, recent therapy with immunosuppressant or anticonvulsants, psychological problems or alcoholic drinkers were excluded from this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marwa Eid

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marwa Eid

City

Cairo

ZIP/Postal Code

2011

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis

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