Hot FlashesNCT04861701
Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise
A study testing Static stretching exercise in people with Hot Flashes, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study investigates the effect and predictors of static stretching exercise on hot flush in women after performing 4-week stretching exercises. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Static stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 30 Jun 2021
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-65 years old.
- With hot flashes.
- No current therapies such as hormone therapy, psychotropic medications, or sleeping pills for the past 6 months.
- With ability to follow instructions of stretching exercise.
Who cannot join
- SBP >160 mmHg or DBP >100 mmHg
- Medical condition under investigation or unstable condition that could affect hot flashes, like thyroid disease.
- Any medical condition limiting the ability to participate the exercise.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming University
Taipei, 112
Mei-Wun Tsai, Ph.D, 886-2-28267939, tmwk@ym.edu.tw
I-Hsuan Lu
About this study
Official title: Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise : A Randomized Controlled Trial
This study investigates the effect and predictors of static stretching exercise on hot flush in women after performing 4-week stretching exercises.
Read the detailed description
Hot flush (HF) is the most common symptom among menopausal syndrome and can significantly affect women's quality of life. Considering the risk of hormone therapy, the behavioral therapies have been proposed for the alternative treatment of HF. However, the exercise prescription for women with HF is controversial. Previous studies show the inconsistent effect of aerobic exercise on HF, and a moderate-to-high intensity exercise seems to aggravate HF frequency and severity. Recent studies have shown that static stretching exercise could improve HF in middle-aged women, but the related research is quite few, and the physiological mechanism as well as predictors for responders who can benefit from stretching exercise are still not clear. The knowledge of predictors for responders will provide clinicians and clients with HF symptoms to choose static stretching exercise as their treatment.
- Conditions
- Hot Flashes
- Being tested
- Static stretching exercise
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static stretching exerciseBehavioural
The intervention of this study is home-based stretching exercise. The experimental group will receive 6 stretching exercises which stretch 60 seconds for each side (left or right) of each movement, and relax for 10-20 seconds between the movements. It will take 10-15 minutes every day for continuous 4 weeks. The 6 stretching exercises include : (1) pectoral muscles + calf muscles ; (2) quadriceps ; (3) levator scapulae ; (4) gluteal muscles ; (5) hamstrings ; (6) trunk side-flexors.
| Study group | Role | What they receive |
|---|---|---|
| Stretching exercise group (SE) | Experimental | All subjects will be assigned to the experimental or control group by randomization. Thus, there will be totally 2 groups : Stretching exercise group (SE) and Control group (CON). Receives: Behavioral: Static stretching exercise |
| Control group (CON) | No intervention | All subjects will be assigned to the experimental or control group by randomization. Thus, there will be totally 2 groups : Stretching exercise group (SE) and Control group (CON). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flush frequency
Frequency of hot flush (time/day)
Measured: pre-intervention
Hot flush frequency
Frequency of hot flush (time/day)
Measured: week 1 of intervention period
Hot flush frequency
Frequency of hot flush (time/day)
Measured: week 2 of intervention period
Hot flush frequency
Frequency of hot flush (time/day)
Measured: week 3 of intervention period
Hot flush frequency
Frequency of hot flush (time/day)
Measured: week 4 of intervention period (post-intervention)
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Measured: pre-intervention
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Measured: week 1 of intervention period
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Measured: week 2 of intervention period
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Measured: week 3 of intervention period
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Measured: week 4 of intervention period (post-intervention)
Secondary outcomes (22)
Standard deviation of NN intervals (SDNN)
SDNN represents total heart rate variability. (unit: ms)
Measured: pre-intervention
Standard deviation of NN intervals (SDNN)
SDNN represents total heart rate variability. (unit: ms)
Measured: week 4 of intervention period (post-intervention)
Absolute total power
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
Measured: pre-intervention
Absolute total power
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
Measured: week 4 of intervention period (post-intervention)
Low frequency in normalized unit (LF norm)
LF norm represents sympathetic nerve activity.
Measured: pre-intervention
Low frequency in normalized unit (LF norm)
LF norm represents sympathetic nerve activity.
Measured: week 4 of intervention period (post-intervention)
High frequency in normalized unit (HF norm)
HF norm represents parasympathetic nerve activity.
Measured: pre-intervention
High frequency in normalized unit (HF norm)
HF norm represents parasympathetic nerve activity.
Measured: week 4 of intervention period (post-intervention)
Percentage of low frequency (LF%)
LF% represents sympathetic nerve activity.
Measured: pre-intervention
Percentage of low frequency (LF%)
LF% represents sympathetic nerve activity.
Measured: week 4 of intervention period (post-intervention)
Percentage of high frequency (HF%)
HF% represents parasympathetic nerve activity.
Measured: pre-intervention
Percentage of high frequency (HF%)
HF% represents parasympathetic nerve activity.
Measured: week 4 of intervention period (post-intervention)
LF/HF ratio (L/H ratio)
L/H ratio represents autonomic nerve balance.
Measured: pre-intervention
LF/HF ratio (L/H ratio)
L/H ratio represents autonomic nerve balance.
Measured: week 4 of intervention period (post-intervention)
Muscle flexibility of upper extremities
Apley's scratch test (unit: cm)
Measured: pre-intervention
Muscle flexibility of upper extremities
Apley's scratch test (unit: cm)
Measured: week 4 of intervention period (post-intervention)
Muscle flexibility of lower extremities
Sit-and-reach test (unit: cm)
Measured: pre-intervention
Muscle flexibility of lower extremities
Sit-and-reach test (unit: cm)
Measured: week 4 of intervention period (post-intervention)
Vascular endothelial function
Reflective index (RI) (unit：％)
Measured: pre-intervention
Vascular endothelial function
Reflective index (RI) (unit：％)
Measured: week 4 of intervention period (post-intervention)
Hot Flush Related Daily Interference Scale (HFRDIS)
Hot Flush Related Daily Interference Scale (HFRDIS), minimum value : 0, maximum value : 100, higher scores mean a worse outcome
Measured: pre-intervention
Hot Flush Related Daily Interference Scale (HFRDIS)
Hot Flush Related Daily Interference Scale (HFRDIS), minimum value : 0, maximum value : 100, higher scores mean a worse outcome
Measured: week 4 of intervention period (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Wun Tsai, National Yang Ming Chiao Tung University
- Investigators
- I-Hsuan Lu, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861701
- Sponsor's protocol ID
- YM109101E
- Status last verified
- May 2021
- First submitted
- 26 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04861701
- Acronym / sponsor ID
- YM109101E
- Conditions
- Hot Flashes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 27 Apr 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.
This study investigates the effect and predictors of static stretching exercise on hot flush in women after performing 4-week stretching exercises.
Detailed description
Hot flush (HF) is the most common symptom among menopausal syndrome and can significantly affect women's quality of life. Considering the risk of hormone therapy, the behavioral therapies have been proposed for the alternative treatment of HF. However, the exercise prescription for women with HF is controversial. Previous studies show the inconsistent effect of aerobic exercise on HF, and a moderate-to-high intensity exercise seems to aggravate HF frequency and severity. Recent studies have shown that static stretching exercise could improve HF in middle-aged women, but the related research is quite few, and the physiological mechanism as well as predictors for responders who can benefit from stretching exercise are still not clear. The knowledge of predictors for responders will provide clinicians and clients with HF symptoms to choose static stretching exercise as their treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching exercise group (SE) | Experimental | Behavioral: Static stretching exerciseAll subjects will be assigned to the experimental or control group by randomization. Thus, there will be totally 2 groups : Stretching exercise group (SE) and Control group (CON). |
| Control group (CON) | No intervention | –All subjects will be assigned to the experimental or control group by randomization. Thus, there will be totally 2 groups : Stretching exercise group (SE) and Control group (CON). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20-65 years old.
- With hot flashes.
- No current therapies such as hormone therapy, psychotropic medications, or sleeping pills for the past 6 months.
- With ability to follow instructions of stretching exercise.
Key exclusion criteria (3 listed)
- SBP >160 mmHg or DBP >100 mmHg
- Medical condition under investigation or unstable condition that could affect hot flashes, like thyroid disease.
- Any medical condition limiting the ability to participate the exercise.
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 |
|---|---|---|
| Static stretching exerciseThe intervention of this study is home-based stretching exercise. The experimental group will receive 6 stretching exercises which stretch 60 seconds for each side (left or right) of each movement, and relax for 10-20 seconds between the movements. It will take 10-15 minutes every day for continuous 4 weeks. The 6 stretching exercises include : (1) pectoral muscles + calf muscles ; (2) quadriceps ; (3) levator scapulae ; (4) gluteal muscles ; (5) hamstrings ; (6) trunk side-flexors. | Behavioural | Stretching exercise group (SE) |
Primary outcome
Hot flush frequency
Time frame: pre-intervention
Frequency of hot flush (time/day)
Hot flush frequency
Time frame: week 1 of intervention period
Frequency of hot flush (time/day)
Hot flush frequency
Time frame: week 2 of intervention period
Frequency of hot flush (time/day)
Hot flush frequency
Time frame: week 3 of intervention period
Frequency of hot flush (time/day)
Hot flush frequency
Time frame: week 4 of intervention period (post-intervention)
Frequency of hot flush (time/day)
Hot flush score
Time frame: pre-intervention
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
Time frame: week 1 of intervention period
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
Time frame: week 2 of intervention period
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
Time frame: week 3 of intervention period
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
Time frame: week 4 of intervention period (post-intervention)
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
22 secondary outcomes
Standard deviation of NN intervals (SDNN)
Time frame: pre-intervention
Standard deviation of NN intervals (SDNN)
Time frame: week 4 of intervention period (post-intervention)
Absolute total power
Time frame: pre-intervention
Absolute total power
Time frame: week 4 of intervention period (post-intervention)
Low frequency in normalized unit (LF norm)
Time frame: pre-intervention
Low frequency in normalized unit (LF norm)
Time frame: week 4 of intervention period (post-intervention)
High frequency in normalized unit (HF norm)
Time frame: pre-intervention
High frequency in normalized unit (HF norm)
Time frame: week 4 of intervention period (post-intervention)
Percentage of low frequency (LF%)
Time frame: pre-intervention
Percentage of low frequency (LF%)
Time frame: week 4 of intervention period (post-intervention)
Percentage of high frequency (HF%)
Time frame: pre-intervention
Percentage of high frequency (HF%)
Time frame: week 4 of intervention period (post-intervention)
LF/HF ratio (L/H ratio)
Time frame: pre-intervention
LF/HF ratio (L/H ratio)
Time frame: week 4 of intervention period (post-intervention)
Muscle flexibility of upper extremities
Time frame: pre-intervention
Muscle flexibility of upper extremities
Time frame: week 4 of intervention period (post-intervention)
Muscle flexibility of lower extremities
Time frame: pre-intervention
Muscle flexibility of lower extremities
Time frame: week 4 of intervention period (post-intervention)
Vascular endothelial function
Time frame: pre-intervention
Vascular endothelial function
Time frame: week 4 of intervention period (post-intervention)
Hot Flush Related Daily Interference Scale (HFRDIS)
Time frame: pre-intervention
Hot Flush Related Daily Interference Scale (HFRDIS)
Time frame: week 4 of intervention period (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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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.
I-Hsuan Lu principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static stretching exercise in people with Hot Flashes, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 7 May 2021. 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 Taiwan. 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 Mei-Wen Tsai, Ph. D (+886+2+28267939, tmwk@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot flush frequency (time frame: pre-intervention). The study lists 10 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 7 May 2021.