Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise

May 4, 2021 updated by: Mei-Wun Tsai, National Yang Ming University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mei-Wen Tsai, Ph. D
  • Phone Number: +886+2+28267939
  • Email: tmwk@ym.edu.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • National Yang Ming University
        • Contact:
          • Mei-Wun Tsai, Ph.D
          • Phone Number: 886-2-28267939
          • Email: tmwk@ym.edu.tw
        • Contact:
          • I-Hsuan Lu
        • Principal Investigator:
          • I-Hsuan Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age between 20-65 years old.
  2. With hot flashes.
  3. No current therapies such as hormone therapy, psychotropic medications, or sleeping pills for the past 6 months.
  4. With ability to follow instructions of stretching exercise.

Exclusion Criteria:

  1. SBP >160 mmHg or DBP >100 mmHg
  2. Medical condition under investigation or unstable condition that could affect hot flashes, like thyroid disease.
  3. Any medical condition limiting the ability to participate the exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Stretching exercise group (SE)
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).
Behavioral: Static stretching exercise
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.
NO_INTERVENTION: Control group (CON)
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hot flush frequency
Time Frame: pre-intervention
Frequency of hot flush (time/day)
pre-intervention
Hot flush frequency
Time Frame: week 1 of intervention period
Frequency of hot flush (time/day)
week 1 of intervention period
Hot flush frequency
Time Frame: week 2 of intervention period
Frequency of hot flush (time/day)
week 2 of intervention period
Hot flush frequency
Time Frame: week 3 of intervention period
Frequency of hot flush (time/day)
week 3 of intervention period
Hot flush frequency
Time Frame: week 4 of intervention period (post-intervention)
Frequency of hot flush (time/day)
week 4 of intervention period (post-intervention)
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)
pre-intervention
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)
week 1 of intervention period
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)
week 2 of intervention period
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)
week 3 of intervention period
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)
week 4 of intervention period (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Standard deviation of NN intervals (SDNN)
Time Frame: pre-intervention
SDNN represents total heart rate variability. (unit: ms)
pre-intervention
Standard deviation of NN intervals (SDNN)
Time Frame: week 4 of intervention period (post-intervention)
SDNN represents total heart rate variability. (unit: ms)
week 4 of intervention period (post-intervention)
Absolute total power
Time Frame: pre-intervention
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
pre-intervention
Absolute total power
Time Frame: week 4 of intervention period (post-intervention)
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
week 4 of intervention period (post-intervention)
Low frequency in normalized unit (LF norm)
Time Frame: pre-intervention
LF norm represents sympathetic nerve activity.
pre-intervention
Low frequency in normalized unit (LF norm)
Time Frame: week 4 of intervention period (post-intervention)
LF norm represents sympathetic nerve activity.
week 4 of intervention period (post-intervention)
High frequency in normalized unit (HF norm)
Time Frame: pre-intervention
HF norm represents parasympathetic nerve activity.
pre-intervention
High frequency in normalized unit (HF norm)
Time Frame: week 4 of intervention period (post-intervention)
HF norm represents parasympathetic nerve activity.
week 4 of intervention period (post-intervention)
Percentage of low frequency (LF%)
Time Frame: pre-intervention
LF% represents sympathetic nerve activity.
pre-intervention
Percentage of low frequency (LF%)
Time Frame: week 4 of intervention period (post-intervention)
LF% represents sympathetic nerve activity.
week 4 of intervention period (post-intervention)
Percentage of high frequency (HF%)
Time Frame: pre-intervention
HF% represents parasympathetic nerve activity.
pre-intervention
Percentage of high frequency (HF%)
Time Frame: week 4 of intervention period (post-intervention)
HF% represents parasympathetic nerve activity.
week 4 of intervention period (post-intervention)
LF/HF ratio (L/H ratio)
Time Frame: pre-intervention
L/H ratio represents autonomic nerve balance.
pre-intervention
LF/HF ratio (L/H ratio)
Time Frame: week 4 of intervention period (post-intervention)
L/H ratio represents autonomic nerve balance.
week 4 of intervention period (post-intervention)
Muscle flexibility of upper extremities
Time Frame: pre-intervention
Apley's scratch test (unit: cm)
pre-intervention
Muscle flexibility of upper extremities
Time Frame: week 4 of intervention period (post-intervention)
Apley's scratch test (unit: cm)
week 4 of intervention period (post-intervention)
Muscle flexibility of lower extremities
Time Frame: pre-intervention
Sit-and-reach test (unit: cm)
pre-intervention
Muscle flexibility of lower extremities
Time Frame: week 4 of intervention period (post-intervention)
Sit-and-reach test (unit: cm)
week 4 of intervention period (post-intervention)
Vascular endothelial function
Time Frame: pre-intervention
Reflective index (RI) (unit：％)
pre-intervention
Vascular endothelial function
Time Frame: week 4 of intervention period (post-intervention)
Reflective index (RI) (unit：％)
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), minimum value : 0, maximum value : 100, higher scores mean a worse outcome
pre-intervention
Hot Flush Related Daily Interference Scale (HFRDIS)
Time Frame: week 4 of intervention period (post-intervention)
Hot Flush Related Daily Interference Scale (HFRDIS), minimum value : 0, maximum value : 100, higher scores mean a worse outcome
week 4 of intervention period (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: I-Hsuan Lu, National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YM109101E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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