NCT04488328

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

July 17, 2020

Last Update Submit

July 22, 2020

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Osteoporosis changes

    BMD by DEXA on each group

    12 weeks

Study Arms (3)

Magnetic Therapy Group

EXPERIMENTAL

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

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

Exercise group

EXPERIMENTAL

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

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

Combined Magnetic Therapy and Exercise Therapy group

EXPERIMENTAL

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

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

Interventions

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

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

Combined Magnetic Therapy and Exercise Therapy groupExercise groupMagnetic Therapy Group

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Marwa Eid

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 28, 2020

Study Start

May 10, 2018

Primary Completion

May 5, 2019

Study Completion

September 20, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

EG(1)