Pelvic Floor Muscle WeaknessPHEdNCT05569694
Movement-Based Pelvic Health Education for Women in Underserved Communities
A study testing Movement-based pelvic health education in people with Pelvic Floor Muscle Weakness and Pelvic Pain, run by Arkansas Colleges of Health Education at 1 site in United States.
Trial summary
It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Pelvic Pain
- What is being tested?
- Movement-based pelvic health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 31 Dec 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 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- female-identifying
- ability to speak English or provide own translator
- ability to complete the questionnaires
- clearance from physician if pregnant
- access to internet
Who cannot join
- -Experiencing pelvic pain and/or pregnant and does not have physician clearance to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Colleges of Health Education
Fort Smith, Arkansas, 72916
About this study
Official title: Pelvic Health Education for Women in Underserved Communities
It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. To address this issue, a movement-based pelvic health education course was developed to assess women's knowledge and adherence of the exercises in an underserved region in Western Arkansas.The purpose of this research was to determine the effectiveness of a single movement-based pelvic health education session on general pelvic health knowledge, underactive pelvic floor, and overactive pelvic floor knowledge and adherence to performing pelvic exercises in women.
- Conditions
- Pelvic Floor Muscle Weakness, Pelvic Pain
- Being tested
- Movement-based pelvic health education
- Keywords
- Women's health, Community education, Underserved population
- Medical subject headings
- Pelvic Pain, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement-based pelvic health educationOther
A single virtual education session led by a physical therapist trained in pelvic health. The virtual course was approximately one hour and included movement-based education through various positions, exercises, and movements with explanations for each pose as it relates to pelvic health.
| Study group | Role | What they receive |
|---|---|---|
| Women in the Community | Experimental | Movement-Based pelvic health education Receives: Other: Movement-based pelvic health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Acquisition
Participants complete a questionnaire pre, post, and one-month following the intervention. The questionnaire includes true/false questions: 10 general knowledge, 10 underactive pelvic floor, 10 overactive pelvic floor. The more correct answers the participant submits, the higher the score. Answer options: True, False, I don't know.
Measured: 1 month
Secondary outcomes (1)
Exercise Adherence
Participants complete a questionnaire pre-session and one-month following the intervention. The questionnaire included questions related to the number of times per week the participant implemented pelvic floor movements and options were:
Never less than once a week about once a week 2 or 3 times a week at least once a day twice on most days twice each day
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start25 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle WeaknessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Colleges of Health Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Kendrick, Arkansas Colleges of Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569694
- Sponsor's protocol ID
- Kendrick PH
- Acronym
- PHEd
- Status last verified
- Jul 2023
- First submitted
- 3 Oct 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Health Education for Women in Underserved Communities
- ClinicalTrials.gov ID
- NCT05569694
- Acronym / sponsor ID
- PHEd / Kendrick PH
- Conditions
- Pelvic Floor Muscle Weakness, Pelvic Pain
- Keywords
- Women's health, Community education, Underserved population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Arkansas Colleges of Health EducationUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 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.
It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. To address this issue, a movement-based pelvic health education course was developed to assess women's knowledge and adherence of the exercises in an underserved region in Western Arkansas.The purpose of this research was to determine the effectiveness of a single movement-based pelvic health education session on general pelvic health knowledge, underactive pelvic floor, and overactive pelvic floor knowledge and adherence to performing pelvic exercises in women.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women in the Community | Experimental | Other: Movement-based pelvic health educationMovement-Based pelvic health education |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- female-identifying
- ability to speak English or provide own translator
- ability to complete the questionnaires
- clearance from physician if pregnant
Key exclusion criteria (1 listed)
- -Experiencing pelvic pain and/or pregnant and does not have physician clearance to participate
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 |
|---|---|---|
| Movement-based pelvic health educationA single virtual education session led by a physical therapist trained in pelvic health. The virtual course was approximately one hour and included movement-based education through various positions, exercises, and movements with explanations for each pose as it relates to pelvic health. | Other | Women in the Community |
Primary outcome
Knowledge Acquisition
Time frame: 1 month
Participants complete a questionnaire pre, post, and one-month following the intervention. The questionnaire includes true/false questions: 10 general knowledge, 10 underactive pelvic floor, 10 overactive pelvic floor. The more correct answers the participant submits, the higher the score. Answer options: True, False, I don't know.
1 secondary outcome
Exercise Adherence
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Floor Muscle Weakness
Recruiting
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness
Active, not recruiting
Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
Urinary Dysfunction, Vaginal Prolapse
Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
Pelvic Floor Disorders, Pelvic Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement-based pelvic health education in people with Pelvic Floor Muscle Weakness and Pelvic Pain, run by Arkansas Colleges of Health Education at 1 site in United States.
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 6 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 24 Jul 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 United States. 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?
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?
Knowledge Acquisition (time frame: 1 month). 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 24 Jul 2023.