HemolysisNCT06223802
Biodex Training in Hemodialysis Females With Osteopenia
A study testing biodex training in people with Hemolysis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
imbalance is a common problem in hemodialysis patients with osteopneia, biodex training is a good device that treat imbalance Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Hemolysis
- What is being tested?
- biodex training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Nov 2023to 8 Mar 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- osteopneia women
- hemodialysis women
Who cannot join
- pregnancy
- autoimmune disorders
- lower limb orthopedic problems
- psychological manifestaion
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahram canadian university
Giza
hagar El-Hadidy, lecturer, hagarhadidy2016@gmail.com
About this study
Official title: Balance Response to Biodex Training in Hemodialysis Females With Osteopenia
imbalance is a common problem in hemodialysis patients with osteopneia, biodex training is a good device that treat imbalance
Read the detailed description
58 women with osteopenia problem and dialysis will be divided to trained women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks or nontrained women group that will act as a control group (n = 29 women)
- Conditions
- Hemolysis
- Being tested
- biodex training
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biodex trainingBehavioural
women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| trained group | Experimental | women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks Receives: Behavioral: biodex training |
| non trained group | No intervention | this group will serve as a control group that will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density of femur bone
it will be measured by DEXA
Measured: it will be measured after 12 weeks
Secondary outcomes (5)
overall stability index
it a parameter indicates the good balance of patients
Measured: it will be measured after 12 weeks
Antero posterior stability index
it a parameter indicates the good balance of patients
Measured: it will be measured after 12 weeks
Mediolateral stability index
it a parameter indicates the good balance of patients
Measured: it will be measured after 12 weeks
six minute walk test
it a parameter asses funntional capacity
Measured: it will be measured after 12 weeks
Short physical performance battery
total score or points will be assessed from this physical performance test
Measured: it will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start8 Nov 2023
- Primary completion8 Mar 2024 (estimated)
- Study completion8 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Ahmed El-Hadidy, Ahram Canadian University
- Investigators
- hagar El-Hadidy, lecturer, Principal investigator, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223802
- Sponsor's protocol ID
- P.T.REC/012/004928
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Response to Biodex Training in Hemodialysis Females With Osteopenia
- ClinicalTrials.gov ID
- NCT06223802
- Acronym / sponsor ID
- P.T.REC/012/004928
- Conditions
- Hemolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 8 Mar 2024 (estimated)
- Study completion
- 8 Mar 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
imbalance is a common problem in hemodialysis patients with osteopneia, biodex training is a good device that treat imbalance
Detailed description
58 women with osteopenia problem and dialysis will be divided to trained women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks or nontrained women group that will act as a control group (n = 29 women)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trained group | Experimental | Behavioral: biodex trainingwomen group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks |
| non trained group | No intervention | –this group will serve as a control group that will receive no intervention |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- osteopneia women
- hemodialysis women
Key exclusion criteria (4 listed)
- pregnancy
- autoimmune disorders
- lower limb orthopedic problems
- psychological manifestaion
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 |
|---|---|---|
| biodex trainingwomen group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks | Behavioural | trained group |
Primary outcome
bone mineral density of femur bone
Time frame: it will be measured after 12 weeks
it will be measured by DEXA
5 secondary outcomes
overall stability index
Time frame: it will be measured after 12 weeks
Antero posterior stability index
Time frame: it will be measured after 12 weeks
Mediolateral stability index
Time frame: it will be measured after 12 weeks
six minute walk test
Time frame: it will be measured after 12 weeks
Short physical performance battery
Time frame: it will be measured after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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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.
hagar El-Hadidy, lecturer principal investigator
Ahram Canadian 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 biodex training in people with Hemolysis, run by Ahram Canadian 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 2 inclusion and 4 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 25 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hagar El-Hadidy, lecturer (01007453552, hagarhadidy2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density of femur bone (time frame: it will be measured after 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 25 Jan 2024.