Hot FlashesPhase 1/2NCT01994655
Chinese Health Ivvestigation Of Nurse Aging
A Phase 1/2 study testing Doing exercise in people with Hot Flashes, run by Bai Wen-Pei.
Trial summary
Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Doing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Sep 2016
- Phase
- Phase 1/2
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 40-55 who has climacteric symptoms
Who cannot join
- Women who have serious climacteric symptoms and other diseases which could interrupt the research.
About this study
Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.
Read the detailed description
Hormone replacement therapy(HRT) is the main therapy to climacteric symptoms. But HRT also has a lot of disadvantages, such as cardiovascular disease, breast cancer .In our previous investigation,we found that doing exercise is helpful for climacteric symptoms.So we want to make a detailed investigation to research it.
- Conditions
- Hot Flashes
- Being tested
- Doing exercise
- Keywords
- climacteric symptoms, menopause, nurses
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doing exerciseOther
Also called Exercise
We want to investigate the effects of exercise on climacteric symptoms
Doing exerciseOther
Also called Exercise
Doing exercise at least 6 months including walking, running, yoga etc.
| Study group | Role | What they receive |
|---|---|---|
| Doing exercise | Experimental | We want to use Kupperman Index to assess the severity of climacteric symptoms,and assess the effect of doing exercise fof the climacteric symptoms Receives: Other: Doing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
KMI
KMI is the short of Kupperman Index,which is a questionnaire to assesses the severity of climacteric symptoms.
Measured: up to 2 years
Secondary outcomes (1)
blood lipid
Blood lipid is an index to assess the effect of doing exercise.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startAug 2008
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bai Wen-Pei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bai Wen-Pei, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994655
- Sponsor's protocol ID
- PEK-8357-wp
- Status last verified
- Nov 2013
- First submitted
- 20 Nov 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Health Ivvestigation Of Nurse Aging
- ClinicalTrials.gov ID
- NCT01994655
- Acronym / sponsor ID
- PEK-8357-wp
- Conditions
- Hot Flashes
- Keywords
- climacteric symptoms, menopause, nurses
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Bai Wen-PeiUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 26 Nov 2013 (estimated)
- 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.
Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.
Detailed description
Hormone replacement therapy(HRT) is the main therapy to climacteric symptoms. But HRT also has a lot of disadvantages, such as cardiovascular disease, breast cancer .In our previous investigation,we found that doing exercise is helpful for climacteric symptoms.So we want to make a detailed investigation to research it.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doing exercise | Experimental | Other: Doing exerciseWe want to use Kupperman Index to assess the severity of climacteric symptoms,and assess the effect of doing exercise fof the climacteric symptoms |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 40-55 who has climacteric symptoms
Key exclusion criteria (1 listed)
- Women who have serious climacteric symptoms and other diseases which could interrupt the research.
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 |
|---|---|---|
| Doing exerciseAlso: ExerciseWe want to investigate the effects of exercise on climacteric symptoms | Other | Doing exercise |
| Doing exerciseAlso: ExerciseDoing exercise at least 6 months including walking, running, yoga etc. | Other | Doing exercise |
Primary outcome
KMI
Time frame: up to 2 years
KMI is the short of Kupperman Index,which is a questionnaire to assesses the severity of climacteric symptoms.
1 secondary outcome
blood lipid
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Doing exercise in people with Hot Flashes, run by Bai Wen-Pei.
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 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 26 Nov 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
KMI (time frame: up to 2 years). 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 26 Nov 2013.