Sleep Disturbances and InsomniaNCT05556317
Effect of Resistive Exercise on Insomnia in Post Menopausal Women
A study testing Resistive exercise in people with Sleep Disturbances and Insomnia, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Sleep Disturbances and Insomnia
- What is being tested?
- Resistive exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2022to 15 Nov 2022
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 50 to 65 years
- non smokers
- BMI 25:29.9
- post menopausal women suffer from insomnia
Who cannot join
- post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia
- women on hormone replacement therapy
- those with diagnosed osteoporosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Professor of physical therapy
Cairo
esraa fikry, Master, 01555358802, fikryesraa148@gmail.com
About this study
Official title: Effect of Resistive Exercise on Plasma Estradiol , Sleep Quality and Insomnia in Post Menopausal Women
the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women
Read the detailed description
Insomnia is a prevalent condition in post menopausal women.resistive exercise might play an important role in insomnia.this trial has two groups ;one will receive advices and the second will receive advices and resistive exercise for four week
- Conditions
- Sleep Disturbances and Insomnia
- Being tested
- Resistive exercise
- Keywords
- Resistive exercise, insomnia, post menopausal women
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistive exerciseBehavioural
advices and resistive exercise
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Receive advices to reduce insomnia Receives: Behavioral: Resistive exercise |
| Group B | Active comparator | Receive advices and resistive exercise Receives: Behavioral: Resistive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index
To determine sleep quality
Measured: Four week
Secondary outcomes (1)
Insomnia severity index
To determine insomnia
Measured: Four week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start30 Sep 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disturbances and InsomniaStudies 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
- Model description
- Resistive exercise on insomnia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Fikry Massoud Yamani, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556317
- Sponsor's protocol ID
- P.T.REC/012/003873
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistive Exercise on Plasma Estradiol , Sleep Quality and Insomnia in Post Menopausal Women
- ClinicalTrials.gov ID
- NCT05556317
- Acronym / sponsor ID
- P.T.REC/012/003873
- Conditions
- Sleep Disturbances and Insomnia
- Keywords
- Resistive exercise, insomnia, post menopausal women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 27 Sep 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.
the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women
Detailed description
Insomnia is a prevalent condition in post menopausal women.resistive exercise might play an important role in insomnia.this trial has two groups ;one will receive advices and the second will receive advices and resistive exercise for four week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Resistive exercise on insomnia
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Resistive exerciseReceive advices to reduce insomnia |
| Group B | Active comparator | Behavioral: Resistive exerciseReceive advices and resistive exercise |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age from 50 to 65 years
- non smokers
- BMI 25:29.9
- post menopausal women suffer from insomnia
Key exclusion criteria (3 listed)
- post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia
- women on hormone replacement therapy
- those with diagnosed osteoporosis
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 |
|---|---|---|
| Resistive exerciseadvices and resistive exercise | Behavioural | Group A, Group B |
Primary outcome
Pittsburgh sleep quality index
Time frame: Four week
To determine sleep quality
1 secondary outcome
Insomnia severity index
Time frame: Four week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistive exercise in people with Sleep Disturbances and Insomnia, 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 3 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 27 Sep 2022. 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 Esraa Fikry Massoud, Master (01555358802, fikryesraa148@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index (time frame: Four week). 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 27 Sep 2022.