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

Study Overview
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Brief Summary
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This study investigates the effect and predictors of static stretching exercise on hot flush in women after performing 4-week stretching exercises.

Detailed Description
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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.

Official Title
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Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise : A Randomized Controlled Trial

Conditions
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Hot Flashes

Intervention / Treatment
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* Behavioral: Static stretching exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stretching exercise group (SE)<br>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<br>* 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.<br>|
| No Intervention: Control group (CON)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flush frequency | Frequency of hot flush (time/day) | pre-intervention | 
| Hot flush frequency | Frequency of hot flush (time/day) | week 1 of intervention period | 
| Hot flush frequency | Frequency of hot flush (time/day) | week 2 of intervention period | 
| Hot flush frequency | Frequency of hot flush (time/day) | week 3 of intervention period | 
| Hot flush frequency | Frequency of hot flush (time/day) | 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) | pre-intervention | 
| Hot flush score | 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 | 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 | 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation of NN intervals (SDNN) | SDNN represents total heart rate variability. (unit: ms) | pre-intervention | 
| Standard deviation of NN intervals (SDNN) | SDNN represents total heart rate variability. (unit: ms) | week 4 of intervention period (post-intervention) | 
| Absolute total power | Absolute total power represents total activity of autonomic nervous system. (unit: ms^2) | pre-intervention | 
| Absolute total power | 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) | LF norm represents sympathetic nerve activity. | pre-intervention | 
| Low frequency in normalized unit (LF norm) | LF norm represents sympathetic nerve activity. | week 4 of intervention period (post-intervention) | 
| High frequency in normalized unit (HF norm) | HF norm represents parasympathetic nerve activity. | pre-intervention | 
| High frequency in normalized unit (HF norm) | HF norm represents parasympathetic nerve activity. | week 4 of intervention period (post-intervention) | 
| Percentage of low frequency (LF%) | LF% represents sympathetic nerve activity. | pre-intervention | 
| Percentage of low frequency (LF%) | LF% represents sympathetic nerve activity. | week 4 of intervention period (post-intervention) | 
| Percentage of high frequency (HF%) | HF% represents parasympathetic nerve activity. | pre-intervention | 
| Percentage of high frequency (HF%) | HF% represents parasympathetic nerve activity. | week 4 of intervention period (post-intervention) | 
| LF/HF ratio (L/H ratio) | L/H ratio represents autonomic nerve balance. | pre-intervention | 
| LF/HF ratio (L/H ratio) | L/H ratio represents autonomic nerve balance. | week 4 of intervention period (post-intervention) | 
| Muscle flexibility of upper extremities | Apley's scratch test (unit: cm) | pre-intervention | 
| Muscle flexibility of upper extremities | Apley's scratch test (unit: cm) | week 4 of intervention period (post-intervention) | 
| Muscle flexibility of lower extremities | Sit-and-reach test (unit: cm) | pre-intervention | 
| Muscle flexibility of lower extremities | Sit-and-reach test (unit: cm) | week 4 of intervention period (post-intervention) | 
| Vascular endothelial function | Reflective index (RI) (unit：％) | pre-intervention | 
| Vascular endothelial function | Reflective index (RI) (unit：％) | 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 | 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 | week 4 of intervention period (post-intervention) |