NCT05505266

Brief Summary

Introduction: The transition to menopause entails several changes in the biopsychosocial sphere of climacteric women. Compared to other therapies, physical exercise has no side effects, is not costly and can have a positive influence on the symptoms reported by women at this stage. The emotional and physical state of climacteric women is affected by the alterations typical of menopause, deteriorating their quality of life. Likewise, physical exercise improves the associated symptomatology. The objective is to know how the study variables (symptomatology, quality of life, emotional state, physical exercise and level of coping) correlate. Material and methods: Cross-sectional descriptive observational design with a study population made up of women in the climacteric stage carried out through an anonymous and voluntary survey.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

August 15, 2022

Last Update Submit

November 11, 2022

Conditions

Keywords

climateric women

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    It is evaluated using the International Physical Activity Questionnaire (IPAQ). This questionnaire in its short version consists of 7 questions about the frequency, duration and intensity of physical activity performed during the last 7 days and is designed to be used with adults between the ages of 18 and 65. The aim is thus to monitor the time spent for each type of activity. Weekly physical activity will be quantified in Metabolic Rate Units (METs) per minute and per week. The reference values used in this questionnaire mark 3.3 METs for walking, 4 METs for moderate physical activity and 8 METs for intense physical activity. These amounts must be multiplied by the time in minutes and by the number of days used to carry out each of the different exercise modalities according to their value. The IPAQ classifies the level of physical activity performed into 3 categories: low, medium and high.

    1 day

Secondary Outcomes (3)

  • Well-being

    1 day

  • Anxiety and depression

    1 day

  • Coping level

    1 day

Interventions

observational

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsclimacteric women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Climacteric women

You may qualify if:

  • Climacteric women
  • Age between 40 and 60 years.

You may not qualify if:

  • \- Not having internet access to complete the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma V Espí-López

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 11, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations