Postmenopausal WomenNCT05782595
Body Balance Responses to Aquatic Therapy Among a Cohort of Healthy Postmenopausal Women
A study testing Aquatic therapy in people with Postmenopausal Women, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to investigate the effect of aquatic Exercises on balance in healthy postmenopausal women . Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Aquatic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2023to 15 Jun 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Their ages will range from 50 to 60 years.
- 2) Their BMI will be less than 30 kg/m².
- 3) All females will be apparently healthy postmenopausal women and walking independency.
- 4) They have physical ability to participate in aquatic exercise program.
Who cannot join
- 1)Urinary or fecal incontinence. 2)Open wounds, contagious skin diseases or infective diseases. 3) Vascular thrombi. 4) Cardiac insufficiency. 5) Fracture in last year in lower limb.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hala mabrouk ali
Giza, 12511
Hala Mabrouk, 01100001862
Hala Mabrouk, 01100001862, Lolamoha2013@gmail.com
About this study
Official title: BODY BALANCE RESPONSES TO AQUATIC THERAPY AMONG ACOHORT OF HEALTHY POSTMENOPAUSAL WOMEN
the aim of this study is to investigate the effect of aquatic Exercises on balance in healthy postmenopausal women .
Read the detailed description
Menopause, defined as the final menstrual period, physiologically results from the natural depletion of ovarian follicular function; a condition that translates into permanent amenorrhea (the permanent cessation of menstrual flow) generally associated with aging.
Many women have few or no symptoms, and thus, these women are not necessarily in need of medical treatment. The signs and symptoms of menopause are characterized by onset of irregular menses, hot flushes and night sweats. Menopause is also known to be associated with changes in behavior and other biological functions e.g., mood swings, anxiety, stress, forgetfulness and sleep disturbances
- Conditions
- Postmenopausal Women
- Being tested
- Aquatic therapy
- Keywords
- Aquatic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic therapyOther
Also called Hydrotherapy
- Each session was divided into three phases:
- Aquatic environment adaptation phase
- stretching phase
- a phase of static and dynamic exercises for balance
| Study group | Role | What they receive |
|---|---|---|
| Aquatic therapy | Experimental | Aquatic exercise program: Each woman in group (A) will receive aquatic exercises for 40 minutes. Receives: Other: Aquatic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance assessment
It is objective device that measure dynamic postural stability and it is reliable for evaluating dynamic postural balance in healthy subjects
Measured: 3 months
Secondary outcomes (1)
The Timed Up and Down Stair Test
- This test is designed to measure dynamic balance (Leroux, 2005). Using an 8-inches high stair, the women will be asked to step on and off seven times at their naturally preferred comfortable pace. They step up with one foot and then the other and step down with one foot followed by the other foot.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start10 Feb 2023
- Primary completion10 May 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Aquatic therapy
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Mabrouk Ali, Cairo University
- Investigators
- Hala Mabrouk, Principal investigator, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782595
- Sponsor's protocol ID
- 012/003731
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BODY BALANCE RESPONSES TO AQUATIC THERAPY AMONG ACOHORT OF HEALTHY POSTMENOPAUSAL WOMEN
- ClinicalTrials.gov ID
- NCT05782595
- Acronym / sponsor ID
- 012/003731
- Conditions
- Postmenopausal Women
- Keywords
- Aquatic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 23 Mar 2023 (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.
the aim of this study is to investigate the effect of aquatic Exercises on balance in healthy postmenopausal women .
Detailed description
Menopause, defined as the final menstrual period, physiologically results from the natural depletion of ovarian follicular function; a condition that translates into permanent amenorrhea (the permanent cessation of menstrual flow) generally associated with aging.
Many women have few or no symptoms, and thus, these women are not necessarily in need of medical treatment. The signs and symptoms of menopause are characterized by onset of irregular menses, hot flushes and night sweats. Menopause is also known to be associated with changes in behavior and other biological functions e.g., mood swings, anxiety, stress, forgetfulness and sleep disturbances
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Aquatic therapy
| Arm | Type | Receives |
|---|---|---|
| Aquatic therapy | Experimental | Other: Aquatic therapyAquatic exercise program: Each woman in group (A) will receive aquatic exercises for 40 minutes. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1) Their ages will range from 50 to 60 years.
- 2) Their BMI will be less than 30 kg/m².
- 3) All females will be apparently healthy postmenopausal women and walking independency.
- 4) They have physical ability to participate in aquatic exercise program.
Key exclusion criteria (1 listed)
- 1)Urinary or fecal incontinence. 2)Open wounds, contagious skin diseases or infective diseases. 3) Vascular thrombi. 4) Cardiac insufficiency. 5) Fracture in last year in lower limb.
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 |
|---|---|---|
| Aquatic therapyAlso: Hydrotherapy• Each session was divided into three phases: 1. Aquatic environment adaptation phase 2. stretching phase 3. a phase of static and dynamic exercises for balance | Other | Aquatic therapy |
Primary outcome
Biodex balance assessment
Time frame: 3 months
It is objective device that measure dynamic postural stability and it is reliable for evaluating dynamic postural balance in healthy subjects
1 secondary outcome
The Timed Up and Down Stair Test
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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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.
Hala Mabrouk principal investigator
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic therapy in people with Postmenopausal Women, 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 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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 Hala Mabrouk (01100001862, Lolamoha2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex balance assessment (time frame: 3 months). 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 Mar 2023.