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

NCT04861701 | Unknown

• 1 other identifier: YM109101E
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (22)

• Standard deviation of NN intervals (SDNN)

  pre-intervention

• Standard deviation of NN intervals (SDNN)

  week 4 of intervention period (post-intervention)

• Absolute total power

  pre-intervention

• Absolute total power

  week 4 of intervention period (post-intervention)

• Low frequency in normalized unit (LF norm)

  pre-intervention

Study Arms (2)

Stretching exercise group (SE)

EXPERIMENTAL

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

Control group (CON)

NO INTERVENTION

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).

Interventions

Static stretching exercise 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.

Stretching exercise group (SE)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Women with hot flashes
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• I-Hsuan Lu

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Wen Tsai, Ph. D

CONTACT

+886+2+28267939; tmwk@ym.edu.tw

I-Hsuan Lu

CONTACT

+886+2+28267939; ihlu1905@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 27, 2021
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

TW (1)