Strength Training EffectsNCT06813404
Building Strength for Menopause
A study testing Heavy resistance training and Yoga in people with Strength Training Effects and Menopausal Women, run by Northeastern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Strength Training Effects, Menopausal Women, Cognitive Function
- What is being tested?
- Heavy resistance training and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 40-60 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02115
About this study
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.
- Being tested
- Heavy resistance training, Yoga
- Keywords
- menopausal women, strength training, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy resistance trainingBehavioural
The heavy resistance training intervention will consist of twice weekly exercise sessions of 60 minutes each.
YogaBehavioural
Twice weekly yoga sessions of 60 minutes each
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Heavy resistance training; Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the exercise intervention at 16 weeks
Secondary outcomes (4)
Muscular strength
Assessed through 1-repetition maximum testing of two compound lifts: barbell box squat and barbell bench press. Tests will be conducted at baseline and at the end of the intervention for both exercise groups.
Measured: From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (executive function)
The Digit Symbol Substitution test will be used to assess components of executive function such as processing speed, working memory, visuospatial processing, and attention. This is recorded as total number of trials and total number of correct trials in 90 seconds.
Measured: From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (working memory)
The Backward Digit Span test will be used to assess working memory and attention. This test is scored as the longest sequenced reached and passed and the total number of attempts.
Measured: From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (memory recall)
The East Boston Memory Test will be used to assess immediate and delayed recall. The test is scored as the correct number of components recalled from a three-sentence story.
Measured: From baseline testing to the end of the exercise intervention at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Why it stopped: Unfunded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strength Training EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility pilot study of heavy resistance training for middle-aged, menopausal women.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813404
- Sponsor's protocol ID
- IRB# 24-12-12
- Status last verified
- May 2025
- First submitted
- 27 Jan 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be de-identified
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Strength for Menopause
- ClinicalTrials.gov ID
- NCT06813404
- Acronym / sponsor ID
- IRB# 24-12-12
- Keywords
- menopausal women, strength training, cognitive function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility pilot study of heavy resistance training for middle-aged, menopausal women.
| Arm | Type | Receives |
|---|---|---|
| First wave of participants (n=30) | Experimental | Behavioral: Heavy resistance training, Behavioral: YogaThis arm is the first round of the exercise intervention, conducted with half (n=30) the anticipated number of participants. |
| Second wave of participants (n=30) | Experimental | Behavioral: Heavy resistance training, Behavioral: YogaThis arm is the second round of participants (n=30) who will receive the same intervention as the first wave. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 40-60 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heavy resistance trainingThe heavy resistance training intervention will consist of twice weekly exercise sessions of 60 minutes each. | Behavioural | First wave of participants (n=30), Second wave of participants (n=30) |
| YogaTwice weekly yoga sessions of 60 minutes each | Behavioural | First wave of participants (n=30), Second wave of participants (n=30) |
Primary outcome
Feasibility (adherence)
Time frame: From enrollment to the end of the exercise intervention at 16 weeks
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.
Feasibility (retention)
Time frame: From enrollment to the end of the exercise intervention at 16 weeks
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.
Acceptability
Time frame: From enrollment to the end of the exercise intervention at 16 weeks
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.
4 secondary outcomes
Muscular strength
Time frame: From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (executive function)
Time frame: From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (working memory)
Time frame: From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (memory recall)
Time frame: From baseline testing to the end of the exercise intervention at 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No. Data will be de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy resistance training and Yoga in people with Strength Training Effects and Menopausal Women, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (adherence) (time frame: From enrollment to the end of the exercise intervention at 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.