更年期周辺期における認知機能向上のための運動 (EPIC)
更年期における抵抗トレーニングと認知機能の健康
Perimenopause is now considered a possible risk factor for dementia and may contribute to the fact that 2/3 of those living with Alzheimer's disease are females. Indeed, research studies show that middle-aged females demonstrate significant declines in their thinking abilities and detrimental changes in their brains as they go through perimenopause. Thus, perimenopausal females need strategies to bolster their brain health.
The World Health Organization strongly recommends physical activity interventions to reduce the risk of decline in thinking abilities. However, whether exercise can improve thinking abilities and brain health in perimenopausal females has not been examined. Our research aims to address this important knowledge gap in female brain health.
We will study the effects of a 6-month resistance exercise training (e.g., lifting free weights, exercise with weight machine) program on thinking abilities in 50 physically inactive perimenopausal females, aged 40 to 55 years, who are experiencing difficulties with their thinking abilities. In addition to measuring thinking abilities, we will determine if exercise benefits muscle health, heart health, sleep quality, psychological well-being, menopausal symptoms, and quality of life. We will also explore how resistance exercise training improves thinking abilities as such information can lead to new discoveries and therapies for brain health in females.
調査の概要
状態
詳細な説明
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PURPOSE:
To determine if progressive resistance training (PRT) can improve cognitive outcomes compared to balance, flexibility, and tone (BAT) exercises in perimenopausal females aged 40-55 years with subjective cognitive complaints.
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HYPOTHESIS:
At the end of the intervention, PRT will result in an increase in words recalled during the RAVLT 20-minute delay vs no improve in BAT.
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JUSTIFICATION:
The menopause transition (MT) negatively impacts cognitive function and the brain. The majority of perimenopausal females experiences cognitive difficulties and have subjective cognitive complaints (SCCs). Verbal episodic memory and processing speed are most negatively impacted by the MT. Cognitive and brain changes during the MT can significantly impact career and financial wellbeing. The MT is thus a critical window to intervene for female brain health. Exercise can reduce dementia risk factors and promote cognitive health. No published randomized controlled trials have examined the effect of exercise on cognitive outcomes in perimenopausal females.
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OBJECTIVE:
To determine if 26 weeks of 2x/week progressive resistance training (PRT) can improve verbal episodic memory performance on the Rey Auditory Verbal Learning Test (RAVLT) compared with balance, flexibility, and tone exercises (BAT) for physically inactive perimenopausal females aged 40-55.
Optional Qualitative Component: To assess knowledge and experiences of perimenopause (pre- and post-intervention), expectations of exercise intervention (pre-intervention), and perceived benefits of exercise intervention (post-intervention).
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RESEARCH DESIGN:
A 26-week, assessor-blinded, two-arm, proof-of-concept trial with 50 physically inactive perimenopausal females, aged 40 to 55 years, with subjective cognitive complaints. Participants will be randomized 1:1 to PRT or BAT and measured at baseline, 13 weeks, and 26 weeks.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Teresa Liu-Ambrose, PhD
- 電話番号：6046178047
- メール：teresa.ambrose@ubc.ca
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ、V5Z 1M9
- 募集
- University of British Columbia
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コンタクト：
- Teresa Liu-Ambrose, MHK
- 電話番号：69059 604-875-4111
- メール：teresa.ambrose@ubc.ca
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Are biological females, as assigned at birth
- Are aged between 40 and 55 years
- Had at least 1 menstrual period in the last 10 months
- Are perimenopausal based on STRAW +10 Staging System, or answer "yes" to MQ6 questions of changes in periods, having hot flashes, or vaginal dryness, pain, or sexual concerns
- Have an intact uterus
- Have a Montreal Cognitive Assessment (MoCA) score >=26/30 for in-person or >=19/22 for telephone , indicating normal cognition
- Have subjective cognitive complaints defined as responding "yes" to "Do you feel like your memory or thinking is becoming worse?"
- Completed high school education
- Read and speak English with acceptable visual and auditory acuity
- Are able to safely engage in moderate-intensity PRT as indicated by the PAR-Q+; and
- Are able to provide informed consent.
Exclusion Criteria:
- Are engaged in regular PRT (i.e., 2x/week) in the prior three months
- Are diagnosed with cognitive impairment or dementia of any type
- Are at high risk for cardiac complications during exercise
- Have clinically important peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility
- Are taking medications that negatively affect cognitive function, such as anticholinergics, major tranquilizers, and anticonvulsants
- Have a BMI <15 or anorexia nervosa; g) had surgical menopause
- Had endometrial ablation that resulted in the loss of menstruation
- Have polycystic ovarian syndrome
- Currently undergoing chemo
- Are using estrogen-containing contraception in the last 12 months
- Had premature ovarian failure; or
- Are already enrolled in a drug or exercise trial
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Progressive Resistance Training (PRT)
Each PRT session will be 1-hr in duration and consists of a warm-up (10 mins), PRT (45 mins), and cool-down (5 mins). 2x/week and group-based. |
The sessions will occur in the Exercise Prescription Suite of the Centre for Aging SMART at VCH; this suite is a fully-equipped gym that includes treadmills, bikes, pneumatic resistance training equipment, and free weights. The training stimulus will initially be at 3 sets of 10-15 repetitions with proper form. At week 4, training intensity will progress from 60-82% of predicted 1 repetition maximum (RM) using the 8RM method. Every 4 weeks the 8RM test will be repeated.
他の名前：
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アクティブコンパレータ：Balance, Flexibility, and Tone Exercises (BAT)
Each BAT session will be 1-hr in duration. 2x/week and group-based. |
Each BAT session will be 1-hr in duration and consist of Pilates mat exercises, Yoga-based poses and breathing, Kegel exercises, stretches, and relaxation techniques (e.g., visualization).
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rey Auditory Verbal Learning Test (RAVLT)
時間枠：Baseline, 13 weeks, 26 weeks
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The RAVLT is a valid, reliable, and widely-used instrument of verbal episodic memory and learning, with normative values. |
Baseline, 13 weeks, 26 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NIH TB Cognitive Battery - Flanker Test
時間枠：Baseline, 13 weeks, 26 weeks
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A measure of executive functions |
Baseline, 13 weeks, 26 weeks
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|
NIH TB Cognitive Battery - Dimensional Change Card Sort Test
時間枠：Baseline, 13 weeks, 26 weeks
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A measure of executive functions |
Baseline, 13 weeks, 26 weeks
|
|
NIH TB Cognitive Battery - Picture Sequence Memory Test
時間枠：Baseline, 13 weeks, 26 weeks
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A measure of visual episodic memory |
Baseline, 13 weeks, 26 weeks
|
|
NIH TB Cognitive Battery - List Sorting Test
時間枠：Baseline, 13 weeks, 26 weeks
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A measure of working memory |
Baseline, 13 weeks, 26 weeks
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NIH TB Cognitive Battery - Pattern Comparison Processing Speed Test
時間枠：Baseline, 13 weeks, 26 weeks
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A measure of processing speed |
Baseline, 13 weeks, 26 weeks
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Everyday Memory Questionnaire
時間枠：Baseline, 13 weeks, 26 weeks
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A subjective measure of memory failure in everyday life |
Baseline, 13 weeks, 26 weeks
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Muscle strength of quads
時間枠：Baseline, 13 weeks, 26 weeks
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Muscle strength measure by isokinetic dynamometer |
Baseline, 13 weeks, 26 weeks
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Peripheral QCT of the tibia
時間枠：Baseline, 13 weeks, 26 weeks
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A measure of bone and muscle health |
Baseline, 13 weeks, 26 weeks
|
|
Blood pressure
時間枠：Baseline, 13 weeks, 26 weeks
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Blood pressure - systolic and diastolic |
Baseline, 13 weeks, 26 weeks
|
|
Lipid panel
時間枠：Baseline, 26 weeks
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Lipid levels |
Baseline, 26 weeks
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Hemoglobin A1-C
時間枠：Baseline, 26 weeks
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Average blood sugar levels |
Baseline, 26 weeks
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C-reactive protein
時間枠：Baseline, 26 weeks
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Measure of inflammation |
Baseline, 26 weeks
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Health resource utilization
時間枠：Baseline, 13 weeks, 26 weeks
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Cost of health resource used |
Baseline, 13 weeks, 26 weeks
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Carotid-femoral pulse wave velocity
時間枠：Baseline, 13 weeks, 26 weeks
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Arterial stiffness |
Baseline, 13 weeks, 26 weeks
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Pittsburgh Sleep Quality Index
時間枠：Baseline, 13 weeks, 26 weeks
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Subjective sleep quality |
Baseline, 13 weeks, 26 weeks
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Actigraph
時間枠：Baseline, 13 weeks, 26 weeks
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Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation). |
Baseline, 13 weeks, 26 weeks
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Actigraph
時間枠：Baseline, 13 weeks, 26 weeks
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Using actigraphy data, quantify physical activity (e.g., intensity and minutes) |
Baseline, 13 weeks, 26 weeks
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Actigraph
時間枠：Baseline, 13 weeks, 26 weeks
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Using actigraphy data, quantify sedentary behaviour (minutes) |
Baseline, 13 weeks, 26 weeks
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Fatigue Severity Scale
時間枠：Baseline, 13 weeks, 26 weeks
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Subjective fatigue |
Baseline, 13 weeks, 26 weeks
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PHQ-9
時間枠：Baseline, 13 weeks, 26 weeks
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Depression severity |
Baseline, 13 weeks, 26 weeks
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GAD-7
時間枠：Baseline, 13 weeks, 26 weeks
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Generalized anxiety disorder |
Baseline, 13 weeks, 26 weeks
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Menopause Rating Scale
時間枠：Baseline, 13 weeks, 26 weeks
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Menopause symptoms |
Baseline, 13 weeks, 26 weeks
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EuroQol-5 Domain-5 Level
時間枠：Baseline, 13 weeks, 26 weeks
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Quality of life |
Baseline, 13 weeks, 26 weeks
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International Physical Activity Questionnaire
時間枠：Every 30 days over 26 weeks
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Physical activity |
Every 30 days over 26 weeks
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DEXA
時間枠：Baseline, 13 weeks, 26 weeks
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Lean mass |
Baseline, 13 weeks, 26 weeks
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DEXA
時間枠：Baseline, 13 weeks, 26 weeks
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Body fat |
Baseline, 13 weeks, 26 weeks
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DEXA
時間枠：Baseline, 13 weeks, 26 weeks
|
Appendicular Skeletal Muscle Mass Index (ASMI); a measure of sarcopenia |
Baseline, 13 weeks, 26 weeks
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Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) Diet score
時間枠：Baseline, 13 weeks, 26 weeks
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Diet |
Baseline, 13 weeks, 26 weeks
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Processing Speed by smartphone
時間枠：Baseline, 13 weeks, 26 weeks
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Processing Speed |
Baseline, 13 weeks, 26 weeks
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Memory by smartphone
時間枠：Baseline, 13 weeks, 26 weeks
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Memory |
Baseline, 13 weeks, 26 weeks
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Productivity Questionnaire
時間枠：Baseline, 13 weeks, 26 weeks
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Measure of work productivity |
Baseline, 13 weeks, 26 weeks
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Brain-Derived Neurotrophic Factor
時間枠：Baseline, 26 weeks
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Neurotrophic Factor |
Baseline, 26 weeks
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IGF-1
時間枠：Baseline, 26 weeks
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Neurotrophic Factor |
Baseline, 26 weeks
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Optional Qualitative Interviews
時間枠：Baseline, 26 weeks
|
The interviews will involve questions about participants' experiences and impact of perimenopause in their daily lives, their expectations of an exercise intervention, and perceived benefits of group-based exercise training |
Baseline, 26 weeks
|
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Optional Measure: Muscle Health
時間枠：Baseline, 26 weeks
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Myosteatosis measured by Upright Open Magnetic Resonance Imaging (UO-MRI) of the mid-thigh and lower leg (dominant) |
Baseline, 26 weeks
|
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Optional Measure: Cerebral Oxygenation
時間枠：Baseline, 13 weeks, 26 weeks
|
Measured by the functional near-infrared spectroscopy (fNIRS) |
Baseline, 13 weeks, 26 weeks
|
協力者と研究者
捜査官
- 主任研究者：Teresa Liu-Ambrose, PhD、University of British Columbia
研究記録日
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研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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