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

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861701
• Other study ID #: YM109101E
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2021
• Source: National Yang Ming University
• Contact: Mei-Wen Tsai, Ph. D
• Phone: +886+2+28267939
• Email: tmwk[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Yang Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flush frequency	Frequency of hot flush (time/day)	pre-intervention
Primary	Hot flush frequency	Frequency of hot flush (time/day)	week 1 of intervention period
Primary	Hot flush frequency	Frequency of hot flush (time/day)	week 2 of intervention period
Primary	Hot flush frequency	Frequency of hot flush (time/day)	week 3 of intervention period
Primary	Hot flush frequency	Frequency of hot flush (time/day)	week 4 of intervention period (post-intervention)
Primary	Hot flush score	The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)	pre-intervention
Primary	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
Primary	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
Primary	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
Primary	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	Standard deviation of NN intervals (SDNN)	SDNN represents total heart rate variability. (unit: ms)	pre-intervention
Secondary	Standard deviation of NN intervals (SDNN)	SDNN represents total heart rate variability. (unit: ms)	week 4 of intervention period (post-intervention)
Secondary	Absolute total power	Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)	pre-intervention
Secondary	Absolute total power	Absolute total power represents total activity of autonomic nervous system. (unit: ms^2)	week 4 of intervention period (post-intervention)
Secondary	Low frequency in normalized unit (LF norm)	LF norm represents sympathetic nerve activity.	pre-intervention
Secondary	Low frequency in normalized unit (LF norm)	LF norm represents sympathetic nerve activity.	week 4 of intervention period (post-intervention)
Secondary	High frequency in normalized unit (HF norm)	HF norm represents parasympathetic nerve activity.	pre-intervention
Secondary	High frequency in normalized unit (HF norm)	HF norm represents parasympathetic nerve activity.	week 4 of intervention period (post-intervention)
Secondary	Percentage of low frequency (LF%)	LF% represents sympathetic nerve activity.	pre-intervention
Secondary	Percentage of low frequency (LF%)	LF% represents sympathetic nerve activity.	week 4 of intervention period (post-intervention)
Secondary	Percentage of high frequency (HF%)	HF% represents parasympathetic nerve activity.	pre-intervention
Secondary	Percentage of high frequency (HF%)	HF% represents parasympathetic nerve activity.	week 4 of intervention period (post-intervention)
Secondary	LF/HF ratio (L/H ratio)	L/H ratio represents autonomic nerve balance.	pre-intervention
Secondary	LF/HF ratio (L/H ratio)	L/H ratio represents autonomic nerve balance.	week 4 of intervention period (post-intervention)
Secondary	Muscle flexibility of upper extremities	Apley's scratch test (unit: cm)	pre-intervention
Secondary	Muscle flexibility of upper extremities	Apley's scratch test (unit: cm)	week 4 of intervention period (post-intervention)
Secondary	Muscle flexibility of lower extremities	Sit-and-reach test (unit: cm)	pre-intervention
Secondary	Muscle flexibility of lower extremities	Sit-and-reach test (unit: cm)	week 4 of intervention period (post-intervention)
Secondary	Vascular endothelial function	Reflective index (RI) (unit:%)	pre-intervention
Secondary	Vascular endothelial function	Reflective index (RI) (unit:%)	week 4 of intervention period (post-intervention)
Secondary	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
Secondary	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)