Building Strength for Menopause

NCT06813404 | Withdrawn

• 1 other identifier: IRB# 24-12-12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study investigating whether heavy resistance training is enjoyable, acceptable, and feasible for middle-aged women undergoing the menopausal transition. Additional outcomes to be assessed include changes to strength and muscle composition as well as changes to cognitive function and self-reported measures of fatigue, cognition, self-efficacy, and mood.

Conditions

Strength Training Effects; Menopausal Women; Cognitive Function

Keywords

menopausal women, strength training, cognitive function

Outcome Measures

Primary Outcomes (3)

• Feasibility (adherence)

  Adherence to the study intervention will be evaluated at the end of each arm, based on recorded attendance. It will be recounted as a percentage.

  From enrollment to the end of the exercise intervention at 16 weeks

• Feasibility (retention)

  Retention of participants in each group will be evaluated at the end of each arm, based on recorded attendance. It will be recounted as a percentage.

  From enrollment to the end of the exercise intervention at 16 weeks

• Acceptability

  Participant enjoyment will be evaluated at the end of each arm, based on self-reported enjoyment after each session, and a final survey for participant feedback on the intervention. Enjoyment will be rated on a Likert scale.

  From enrollment to the end of the exercise intervention at 16 weeks

Secondary Outcomes (4)

• Muscular strength

  From baseline testing to the end of the exercise intervention at 16 weeks

• Cognitive function (executive function)

  From baseline testing to the end of the exercise intervention at 16 weeks

• Cognitive function (working memory)

  From baseline testing to the end of the exercise intervention at 16 weeks

• Cognitive function (memory recall)

  From baseline testing to the end of the exercise intervention at 16 weeks

Other Outcomes (1)

• Body composition

  From baseline testing to the end of the exercise intervention at 16 weeks

Study Arms (2)

First wave of participants (n=30)

EXPERIMENTAL

This arm is the first round of the exercise intervention, conducted with half (n=30) the anticipated number of participants.

Behavioral: Heavy resistance training; Behavioral: Yoga

Second wave of participants (n=30)

EXPERIMENTAL

This arm is the second round of participants (n=30) who will receive the same intervention as the first wave.

Behavioral: Heavy resistance training; Behavioral: Yoga

Interventions

Heavy resistance training BEHAVIORAL

The heavy resistance training intervention will consist of twice weekly exercise sessions of 60 minutes each.

First wave of participants (n=30); Second wave of participants (n=30)

Yoga BEHAVIORAL

Twice weekly yoga sessions of 60 minutes each

First wave of participants (n=30); Second wave of participants (n=30)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age at study enrollment
• Currently experiencing symptoms related to menopause
• Low physical activity levels at study enrollment (not meeting CDC guidelines of 150 minutes moderate/75 minutes vigorous activity per week)
• No regular (\>1x per week) participation in heavy resistance training or yoga exercise within the past 6 months
• Physician's consent to participate in strength testing and the exercise program (if deemed necessary)
• Ambulatory
• Absence of health conditions that may be exacerbated by exercise
• Good or corrected vision and hearing
• Intention to remain in the Boston area for the duration of the study
• Willingness to complete study assessments
• Ability to read, write and understand English
• Not currently enrolled in another PA study

You may not qualify if:

• Under 40 or over 60 years
• Pregnant or planning to become pregnant
• Moderate to high physical activity levels at enrollment (meeting CDC guidelines)
• Currently participating regularly (\>1x per week) in a heavy resistance training or yoga program
• Non-consent of physician (if deemed necessary)
• Non-ambulatory (e.g. use of walkers, wheelchairs)
• Presence of health conditions that may be exacerbated by exercise (arthritis, musculoskeletal disorders, etc.)
• Problems with vision or hearing
• Intent to move or take an extended (\>2 weeks) vacation during the testing time points (baseline, 4 months)
• Unwilling to complete study assessments
• Currently enrolled in another PA study

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysis will be blinded such that the analyst does not know which group each result is associated with. Efforts will be made to have final testing blinded, however if resources are limited, final testing will be done by exercise intervention leads.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility pilot study of heavy resistance training for middle-aged, menopausal women.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 7, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)