PostmenopausalNCT05009238
Effect of l S Exercises on Balance and Spatiotemporal Gait Parameters in P M Women
A study testing lumbar stabilization exercises in people with Postmenopausal, run by Hend Hamdy.
Trial summary
Menopause is a natural process in women's life with hormonal fluctuations that cause physical and emotional symptoms such as(Hot flashes, insomnia, physical in activity, unstable mood, difficulties in memory and concentration, anxiety, stress, irritability, unstable body mass, sexual dysfunction, feelings of sadness… Read more about this study
- Who is it for?
- Ages 45 to 59 years, women only
- Conditions the study is for
- Postmenopausal
- What is being tested?
- lumbar stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to Apr 2023
- 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 45 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-menopausal women: Their age will be ranged between 45-59 years old, with low back pain.
Who cannot join
- Infection disease or fever.
- Foot ulcers.
- Foot infection or undergoing foot surgery.
- Recent fracture in foot and toes with unhealed wounds.
- Thrombotic disease of lower extremities.
- Deep proprioception loss.
- Peripheral neuropathy.
- Gout or advanced arthritis affecting the foot and toes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Lumbar Stabilization Exercises on Balance and Spatiotemporal Gait Parameters in Postmenopausal Women
Menopause is a natural process in women's life with hormonal fluctuations that cause physical and emotional symptoms such as(Hot flashes, insomnia, physical in activity, unstable mood, difficulties in memory and concentration, anxiety, stress, irritability, unstable body mass, sexual dysfunction, feelings of sadness, infertility, and depression).
Balance disturbances are common in the community as a whole and increase in frequency with age. The risk of falling increases from age 45 in women and peaks in the 55-59-year age group. Around the time of the menopause, estrogen production decreases dramatically and bone loss accelerates, which predisposes for fractures if a fall occurs.
- Conditions
- Postmenopausal
- Being tested
- lumbar stabilization exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar stabilization exercisesOther
selected exercises will taught to participant and practiced 3 times per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Group (A): will receive lumbar stabilization exercises Receives: Other: lumbar stabilization exercises |
| Group (B) | No intervention | Group (B): will be control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length
the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot measured by cm
Measured: about 6 weeks.
step symmetry
right to left time distribution measured by second
Measured: about 6 weeks.
walking speed
the ratio of distance to the time in which the distance was covered by the subject measured by m/s
Measured: about 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Oct 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies 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
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hend Hamdy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hend Hamdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009238
- Sponsor's protocol ID
- p.T.RCE/012/003190
- Status last verified
- Aug 2022
- First submitted
- 23 Jul 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lumbar Stabilization Exercises on Balance and Spatiotemporal Gait Parameters in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05009238
- Acronym / sponsor ID
- p.T.RCE/012/003190
- Conditions
- Postmenopausal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hend HamdyUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 17 Aug 2021 (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.
Menopause is a natural process in women's life with hormonal fluctuations that cause physical and emotional symptoms such as(Hot flashes, insomnia, physical in activity, unstable mood, difficulties in memory and concentration, anxiety, stress, irritability, unstable body mass, sexual dysfunction, feelings of sadness, infertility, and depression).
Balance disturbances are common in the community as a whole and increase in frequency with age. The risk of falling increases from age 45 in women and peaks in the 55-59-year age group. Around the time of the menopause, estrogen production decreases dramatically and bone loss accelerates, which predisposes for fractures if a fall occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Other: lumbar stabilization exercisesGroup (A): will receive lumbar stabilization exercises |
| Group (B) | No intervention | –Group (B): will be control group. |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post-menopausal women: Their age will be ranged between 45-59 years old, with low back pain.
Key exclusion criteria (8 listed)
- Infection disease or fever.
- Foot ulcers.
- Foot infection or undergoing foot surgery.
- Recent fracture in foot and toes with unhealed wounds.
- Thrombotic disease of lower extremities.
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 |
|---|---|---|
| lumbar stabilization exercisesselected exercises will taught to participant and practiced 3 times per week for 6 weeks | Other | Group (A) |
Primary outcome
Step length
Time frame: about 6 weeks.
the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot measured by cm
step symmetry
Time frame: about 6 weeks.
right to left time distribution measured by second
walking speed
Time frame: about 6 weeks.
the ratio of distance to the time in which the distance was covered by the subject measured by m/s
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar stabilization exercises in people with Postmenopausal, run by Hend Hamdy.
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 8 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 23 Aug 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 Hend Hamdy, PHD (01024420121, hendhamdy110@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length (time frame: about 6 weeks.). The study lists 3 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 23 Aug 2022.