Active and healthy aging in women during early postmenopause

Not Applicable

• Conditions: Health promotion in generally healthy women in early postmenopause (45-65 years old); Not Applicable

• Registration Number: ISRCTN16251361
• Lead Sponsor: niversity of Granada

Brief Summary

2023 Protocol article in https://doi.org/10.1186/s40359-023-01245-9 (added 13/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-01
• Last Update Posted: 25 July 2023
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Current participant inclusion criteria as of 08/06/2023:
For all study groups:
1. Postmenopausal women between 45 and 65 years with no menses for 12 months or more until 10 years of postmenopause, based on Stages of Reproductive Aging Workshop STRAW +10 criteria
2. Providing a signed consent form for voluntary participation
3. Speaking and reading Spanish with proficiency
4. Being in good health for exercising

For intervention and sedentary control groups:
1. Being sedentary, i.e., not exercising on a regular basis, independently of daily physical activity such as walking for transportation, for at least the last 12 months

For the active control group:
1. Exercising on a regular basis reaching international recommended levels for at least the last 12 months

Previous participant inclusion criteria:
For all study groups:
1. Postmenopausal women between 45 and 65 years with no menses for 12 months or more until 10 years of postmenopause, based on Stages of Reproductive Aging Workshop STRAW +10 criteria
2. Non-use of hormone therapy in at least the three months before recruitment
3. Providing a signed consent form for voluntary participation
4. Speaking and reading Spanish with proficiency
5. Not suffering from any severe physical or mental disease that would seriously deteriorate functioning, impede participation in exercise based on medical criteria or introduce bias in responses.

For intervention and sedentary control groups:
1. Not exercising on a regular basis, independently of daily physical activity, e.g., walking for transportation, for at least the last 12 months

For the active control group:
1. Exercising on a regular basis reaching international recommended levels for at least the last 12 months
2. Not being an athlete (i.e., competitive sport) of any performance level

Exclusion Criteria

Current participant exclusion criteria as of 08/06/2023:
1. Non-use of hormone therapy in at least the three months before recruitment
2. Not suffering from any severe physical or mental disease that would seriously deteriorate functioning, impede participation in exercise based on medical criteria or introduce bias in responses
3. For active controls, not being an athlete (i.e., competitive sport) of any performance level

Previous participant exclusion criteria:
Does not meet the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise behavior measured using the self-reported International Physical Activity Questionnaire (IPAQ) at baseline, postintervention and follow-ups