OsteoporosisNCT04488328
Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis
A study testing patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks in people with Osteoporosis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2018to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All participants had undergone thyroidectomy since 6 months and had cognitive and educational level enough to understand the requirements of the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Osteoporosis
- Being tested
- patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis changes
BMD by DEXA on each group
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start10 May 2018
- Primary completion5 May 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
- Investigators
- Marwa Eid, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488328
- Sponsor's protocol ID
- 68m
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis
- ClinicalTrials.gov ID
- NCT04488328
- Acronym / sponsor ID
- 68m
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnetic Therapy Group | Experimental | Other: patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weekspatients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks |
| Exercise group | Experimental | Other: patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weekspatients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks |
| Combined Magnetic Therapy and Exercise Therapy group | Experimental | Other: patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weekspatients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants had undergone thyroidectomy since 6 months and had cognitive and educational level enough to understand the requirements of the study
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weekspatients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks(3 sessions/ week) | Other | Combined Magnetic Therapy and Exercise Therapy group, Exercise group, Magnetic Therapy Group |
Primary outcome
Osteoporosis changes
Time frame: 12 weeks
BMD by DEXA on each group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Eid principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks in people with Osteoporosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoporosis changes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.