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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heavy resistance training | Behavioral | The heavy resistance training intervention will consist of twice weekly exercise sessions of 60 minutes each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline testing to the end of the exercise intervention at 16 weeks |
| Cognitive function (executive function) |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | As an option, participants may complete a DEXA scan to assess body composition. This will be used to assess changes to lean body mass. | From baseline testing to the end of the exercise intervention at 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeastern University | Boston | Massachusetts | 02115 | United States |
Data will be de-identified
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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Feasibility pilot study of heavy resistance training for middle-aged, menopausal women.
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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.
| Yoga | Behavioral | Twice weekly yoga sessions of 60 minutes each |
|
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. |
| 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. | 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. | From baseline testing to the end of the exercise intervention at 16 weeks |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |