Clinical trial NCT04861701: Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise
Official title: Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hot Flashes
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hot flush frequency
timeFrame: pre-intervention
measure: Hot flush frequency
timeFrame: week 1 of intervention period
measure: Hot flush frequency
timeFrame: week 2 of intervention period
measure: Hot flush frequency
timeFrame: week 3 of intervention period
measure: Hot flush frequency
timeFrame: week 4 of intervention period (post-intervention)
measure: Hot flush score
timeFrame: pre-intervention
measure: Hot flush score
timeFrame: week 1 of intervention period
measure: Hot flush score
timeFrame: week 2 of intervention period
measure: Hot flush score
timeFrame: week 3 of intervention period
measure: Hot flush score
timeFrame: week 4 of intervention period (post-intervention)
Secondary outcomes:
measure: Standard deviation of NN intervals (SDNN)
timeFrame: pre-intervention
measure: Standard deviation of NN intervals (SDNN)
timeFrame: week 4 of intervention period (post-intervention)
measure: Absolute total power
timeFrame: pre-intervention
measure: Absolute total power
timeFrame: week 4 of intervention period (post-intervention)
measure: Low frequency in normalized unit (LF norm)
timeFrame: pre-intervention
measure: Low frequency in normalized unit (LF norm)
timeFrame: week 4 of intervention period (post-intervention)
measure: High frequency in normalized unit (HF norm)
timeFrame: pre-intervention
measure: High frequency in normalized unit (HF norm)
timeFrame: week 4 of intervention period (post-intervention)
measure: Percentage of low frequency (LF%)
timeFrame: pre-intervention
measure: Percentage of low frequency (LF%)
timeFrame: week 4 of intervention period (post-intervention)
measure: Percentage of high frequency (HF%)
timeFrame: pre-intervention
measure: Percentage of high frequency (HF%)
timeFrame: week 4 of intervention period (post-intervention)
measure: LF/HF ratio (L/H ratio)
timeFrame: pre-intervention
measure: LF/HF ratio (L/H ratio)
timeFrame: week 4 of intervention period (post-intervention)
measure: Muscle flexibility of upper extremities
timeFrame: pre-intervention
measure: Muscle flexibility of upper extremities
timeFrame: week 4 of intervention period (post-intervention)
measure: Muscle flexibility of lower extremities
timeFrame: pre-intervention
measure: Muscle flexibility of lower extremities
timeFrame: week 4 of intervention period (post-intervention)
measure: Vascular endothelial function
timeFrame: pre-intervention
measure: Vascular endothelial function
timeFrame: week 4 of intervention period (post-intervention)
measure: Hot Flush Related Daily Interference Scale (HFRDIS)
timeFrame: pre-intervention
measure: Hot Flush Related Daily Interference Scale (HFRDIS)
timeFrame: week 4 of intervention period (post-intervention)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: I-Hsuan Lu
role: PRINCIPAL_INVESTIGATOR
References: