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

NCT ID: NCT04861701

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-06-30

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.

Conditions

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Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Static stretching exercise

Intervention Type BEHAVIORAL

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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Mei-Wun Tsai

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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I-Hsuan Lu

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

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National Yang Ming University

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mei-Wen Tsai, Ph. D

Role: CONTACT

+886+2+28267939

I-Hsuan Lu

Role: CONTACT

+886+2+28267939

Facility Contacts

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Mei-Wun Tsai, Ph.D

Role: primary

886-2-28267939

I-Hsuan Lu

Role: backup

Other Identifiers

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YM109101E

Identifier Type: -

Identifier Source: org_study_id

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