Diabetes Mellitus, Type 1NCT05577286
Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis
A study testing regular care and plyometric training in people with Diabetes Mellitus, Type 1, run by Cairo University.
Trial summary
Despite the benefits of physical rehabilitation among adults and children with chronic illness such as Diabetes mellitus avoid engaging in different physical activities especially pediatric population. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- regular care and plyometric training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 30 Nov 2024
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age will range from six to 10 years
- Both sexes
- Chronicity of the disease ranges from 3 to <5 years.
- Controlled diabetes with insulin dosage described by physician.
Who cannot join
- Heriderty sensory or autonomic peripheral neuropathy.
- Unstable cardio-vascular disorders
- History of fractures or surgery in the lower extremities in the past 12 months.
- Diagnosed with other hormonal diseases.
- Children who practice regular sports.
Trial locations and contacts
No sites are listed yet.
About this study
Despite the benefits of physical rehabilitation among adults and children with chronic illness such as Diabetes mellitus avoid engaging in different physical activities especially pediatric population. Most of the children with type 1 Diabetes mellitus receive their medical treatment and follow-up with no change of their functional performance.
Read the detailed description
We still lack the evidence of plyometric exercises in pediatric population with Diabetes mellitus . Therefore, the primary aim of this study is to explore the effects of plyometric exercises on blood glucose level, balance and muscle strength in children with 1 Diabetes mellitus
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- regular care, plyometric training
- Keywords
- Diabetes mellitus, type 1 1 Diabetes mellitus, plyometric exercises, balance, muscle strength
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular careOther
the regular medical treatment without change of their daily activity routine
plyometric trainingOther
designed plyometric training program for 30 minutes, three times a week for two successive months
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | 15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment without change of their daily activity routine Receives: Other: regular care |
| plyometric group | Experimental | 15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment as in control group in addition to a designed plyometric training program for 30 minutes, three times a week for two successive months. Receives: Other: regular care; Other: plyometric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
assessment of hip, knee and ankle muscles by The Laffayette manual muscle testing (model 01163 USA) which measure strength in kG.
Measured: after 3 successive months
balance
assessment of balance by The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA).
Measured: after 3 successive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Doaa A Mahmoud Sanad, Phd, Study chair, Cairo university, faculty of physical therapySamya M Aly Hussein, B.Sc., Principal investigator, Cairo university, faculty of physical therapyAboalnaga A Abdelrahim Hamed, Study director, Cairo university, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577286
- Sponsor's protocol ID
- type 1 diabetes
- Status last verified
- Dec 2022
- First submitted
- 27 Sep 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis
- ClinicalTrials.gov ID
- NCT05577286
- Acronym / sponsor ID
- type 1 diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes mellitus, type 1 1 Diabetes mellitus, plyometric exercises, balance, muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
Despite the benefits of physical rehabilitation among adults and children with chronic illness such as Diabetes mellitus avoid engaging in different physical activities especially pediatric population. Most of the children with type 1 Diabetes mellitus receive their medical treatment and follow-up with no change of their functional performance.
Detailed description
We still lack the evidence of plyometric exercises in pediatric population with Diabetes mellitus . Therefore, the primary aim of this study is to explore the effects of plyometric exercises on blood glucose level, balance and muscle strength in children with 1 Diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: regular care15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment without change of their daily activity routine |
| plyometric group | Experimental | Other: regular care, Other: plyometric training15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment as in control group in addition to a designed plyometric training program for 30 minutes, three times a week for two successive months. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age will range from six to 10 years
- Both sexes
- Chronicity of the disease ranges from 3 to <5 years.
- Controlled diabetes with insulin dosage described by physician.
Key exclusion criteria (5 listed)
- Heriderty sensory or autonomic peripheral neuropathy.
- Unstable cardio-vascular disorders
- History of fractures or surgery in the lower extremities in the past 12 months.
- Diagnosed with other hormonal diseases.
- Children who practice regular sports.
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 |
|---|---|---|
| regular carethe regular medical treatment without change of their daily activity routine | Other | control group, plyometric group |
| plyometric trainingdesigned plyometric training program for 30 minutes, three times a week for two successive months | Other | plyometric group |
Primary outcome
muscle strength
Time frame: after 3 successive months
assessment of hip, knee and ankle muscles by The Laffayette manual muscle testing (model 01163 USA) which measure strength in kG.
balance
Time frame: after 3 successive months
assessment of balance by The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
Doaa A Mahmoud Sanad, Phd study chair
Cairo university, faculty of physical therapy
Samya M Aly Hussein, B.Sc. principal investigator
Cairo university, faculty of physical therapy
Aboalnaga A Abdelrahim Hamed study director
Cairo university, faculty of physical therapy
Questions about this trial
What is this clinical trial studying?
A study testing regular care and plyometric training in people with Diabetes Mellitus, Type 1, run by Cairo University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira M Abd-elmonem, PhD (01155553316, Dramira.salim2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: after 3 successive months). The study lists 2 primary outcomes in all. 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 2 Dec 2022.