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

Not Applicable

• Conditions: Hot Flashes
• Interventions: Behavioral: Static stretching exercise

• Registration Number: NCT04861701
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stretching exercise group (SE)	Static stretching exercise	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).

Primary Outcome Measures

Name	Time	Method
Hot flush frequency	week 4 of intervention period (post-intervention)	Frequency of hot flush (time/day)
Hot flush score	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Yang Ming University; 🇨🇳 Taipei, Taiwan