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

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: Recruiting
• Conditions: Hot Flashes
• Intervention / Treatment: Behavioral: Static stretching 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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mei-Wen Tsai, Ph. D; Phone Number: +886+2+28267939; Email: tmwk@ym.edu.tw
• Study Contact Backup: Name: I-Hsuan Lu; Phone Number: +886+2+28267939; Email: ihlu1905@gmail.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: I-Hsuan Lu, National Yang Ming University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (ACTUAL): April 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID 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