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

Primary Purpose

Hot Flashes

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Static stretching exercise
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hot Flashes

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Yang Ming UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stretching exercise group (SE)

Control group (CON)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Hot flush frequency
Frequency of hot flush (time/day)
Hot flush frequency
Frequency of hot flush (time/day)
Hot flush frequency
Frequency of hot flush (time/day)
Hot flush frequency
Frequency of hot flush (time/day)
Hot flush frequency
Frequency of hot flush (time/day)
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Hot flush score
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)

Secondary Outcome Measures

Standard deviation of NN intervals (SDNN)
SDNN represents total heart rate variability. (unit: ms)
Standard deviation of NN intervals (SDNN)
SDNN represents total heart rate variability. (unit: ms)
Absolute total power
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
Absolute total power
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
Low frequency in normalized unit (LF norm)
LF norm represents sympathetic nerve activity.
Low frequency in normalized unit (LF norm)
LF norm represents sympathetic nerve activity.
High frequency in normalized unit (HF norm)
HF norm represents parasympathetic nerve activity.
High frequency in normalized unit (HF norm)
HF norm represents parasympathetic nerve activity.
Percentage of low frequency (LF%)
LF% represents sympathetic nerve activity.
Percentage of low frequency (LF%)
LF% represents sympathetic nerve activity.
Percentage of high frequency (HF%)
HF% represents parasympathetic nerve activity.
Percentage of high frequency (HF%)
HF% represents parasympathetic nerve activity.
LF/HF ratio (L/H ratio)
L/H ratio represents autonomic nerve balance.
LF/HF ratio (L/H ratio)
L/H ratio represents autonomic nerve balance.
Muscle flexibility of upper extremities
Apley's scratch test (unit: cm)
Muscle flexibility of upper extremities
Apley's scratch test (unit: cm)
Muscle flexibility of lower extremities
Sit-and-reach test (unit: cm)
Muscle flexibility of lower extremities
Sit-and-reach test (unit: cm)
Vascular endothelial function
Reflective index (RI) (unit:%)
Vascular endothelial function
Reflective index (RI) (unit:%)
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
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

Full Information

First Posted
April 26, 2021
Last Updated
May 4, 2021
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04861701
Brief Title
Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise
Official Title
Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stretching exercise group (SE)
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group (CON)
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Static stretching exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hot flush frequency
Description
Frequency of hot flush (time/day)
Time Frame
pre-intervention
Title
Hot flush frequency
Description
Frequency of hot flush (time/day)
Time Frame
week 1 of intervention period
Title
Hot flush frequency
Description
Frequency of hot flush (time/day)
Time Frame
week 2 of intervention period
Title
Hot flush frequency
Description
Frequency of hot flush (time/day)
Time Frame
week 3 of intervention period
Title
Hot flush frequency
Description
Frequency of hot flush (time/day)
Time Frame
week 4 of intervention period (post-intervention)
Title
Hot flush score
Description
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Time Frame
pre-intervention
Title
Hot flush score
Description
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Time Frame
week 1 of intervention period
Title
Hot flush score
Description
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Time Frame
week 2 of intervention period
Title
Hot flush score
Description
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Time Frame
week 3 of intervention period
Title
Hot flush score
Description
The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)
Time Frame
week 4 of intervention period (post-intervention)
Secondary Outcome Measure Information:
Title
Standard deviation of NN intervals (SDNN)
Description
SDNN represents total heart rate variability. (unit: ms)
Time Frame
pre-intervention
Title
Standard deviation of NN intervals (SDNN)
Description
SDNN represents total heart rate variability. (unit: ms)
Time Frame
week 4 of intervention period (post-intervention)
Title
Absolute total power
Description
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
Time Frame
pre-intervention
Title
Absolute total power
Description
Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)
Time Frame
week 4 of intervention period (post-intervention)
Title
Low frequency in normalized unit (LF norm)
Description
LF norm represents sympathetic nerve activity.
Time Frame
pre-intervention
Title
Low frequency in normalized unit (LF norm)
Description
LF norm represents sympathetic nerve activity.
Time Frame
week 4 of intervention period (post-intervention)
Title
High frequency in normalized unit (HF norm)
Description
HF norm represents parasympathetic nerve activity.
Time Frame
pre-intervention
Title
High frequency in normalized unit (HF norm)
Description
HF norm represents parasympathetic nerve activity.
Time Frame
week 4 of intervention period (post-intervention)
Title
Percentage of low frequency (LF%)
Description
LF% represents sympathetic nerve activity.
Time Frame
pre-intervention
Title
Percentage of low frequency (LF%)
Description
LF% represents sympathetic nerve activity.
Time Frame
week 4 of intervention period (post-intervention)
Title
Percentage of high frequency (HF%)
Description
HF% represents parasympathetic nerve activity.
Time Frame
pre-intervention
Title
Percentage of high frequency (HF%)
Description
HF% represents parasympathetic nerve activity.
Time Frame
week 4 of intervention period (post-intervention)
Title
LF/HF ratio (L/H ratio)
Description
L/H ratio represents autonomic nerve balance.
Time Frame
pre-intervention
Title
LF/HF ratio (L/H ratio)
Description
L/H ratio represents autonomic nerve balance.
Time Frame
week 4 of intervention period (post-intervention)
Title
Muscle flexibility of upper extremities
Description
Apley's scratch test (unit: cm)
Time Frame
pre-intervention
Title
Muscle flexibility of upper extremities
Description
Apley's scratch test (unit: cm)
Time Frame
week 4 of intervention period (post-intervention)
Title
Muscle flexibility of lower extremities
Description
Sit-and-reach test (unit: cm)
Time Frame
pre-intervention
Title
Muscle flexibility of lower extremities
Description
Sit-and-reach test (unit: cm)
Time Frame
week 4 of intervention period (post-intervention)
Title
Vascular endothelial function
Description
Reflective index (RI) (unit:%)
Time Frame
pre-intervention
Title
Vascular endothelial function
Description
Reflective index (RI) (unit:%)
Time Frame
week 4 of intervention period (post-intervention)
Title
Hot Flush Related Daily Interference Scale (HFRDIS)
Description
Hot Flush Related Daily Interference Scale (HFRDIS), minimum value : 0, maximum value : 100, higher scores mean a worse outcome
Time Frame
pre-intervention
Title
Hot Flush Related Daily Interference Scale (HFRDIS)
Description
Hot Flush Related Daily Interference Scale (HFRDIS), minimum value : 0, maximum value : 100, higher scores mean a worse outcome
Time Frame
week 4 of intervention period (post-intervention)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with hot flashes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-Wen Tsai, Ph. D
Phone
+886+2+28267939
Email
tmwk@ym.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
I-Hsuan Lu
Phone
+886+2+28267939
Email
ihlu1905@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Hsuan Lu
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei-Wun Tsai, Ph.D
Phone
886-2-28267939
Email
tmwk@ym.edu.tw
First Name & Middle Initial & Last Name & Degree
I-Hsuan Lu
First Name & Middle Initial & Last Name & Degree
I-Hsuan Lu

12. IPD Sharing Statement

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

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