Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
2021年9月9日 更新者：Agustín Aibar Almazán、University of Jaén
Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
調査の概要
詳細な説明
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
研究の種類
介入
入学 (実際)
107
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Jaén、スペイン、23002
- Center of active participation of seniors of Jaén "Catedral"
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- No menstrual activity for at least 12 months.
- Present obesity and / or sarcopenic.
- Do not participate in a weight loss program.
- Be able to understand the instructions, programs and protocols of this project.
Exclusion Criteria:
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 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：ピラティスグループ
ピラティスエクササイズをベースとしたフィジカルトレーニングを受けるグループです。
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Training based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty. |
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介入なし：介入なしグループ
このグループはいかなる治療も受けていない
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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 |
|---|---|---|
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骨格筋量 (kg)
時間枠：開始時と3か月時
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ほぼ骨格筋で構成され、全身骨格筋の約70％を占める四肢の筋肉量に基づいて計算されます
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開始時と3か月時
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TUG (Timed Up and Go テスト)
時間枠：開始時と3か月時
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人の可動性と身体機能を評価するために使用される簡単なテストです
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開始時と3か月時
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X平均
時間枠：開始時と3か月時
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圧力中心の横振動の平均値
|
開始時と3か月時
|
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つまり
時間枠：開始時と3か月時
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圧力中心の前後振動の平均値
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開始時と3か月時
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Dynamometer
時間枠：At the beginning and at three months
|
Dynamometer will be employed to assess hand grip stregth.
|
At the beginning and at three months
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ABC-16 (Activities Specific Balance Confidence Scale)
時間枠：At the beginning and at three months
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Questionnaire that assesses balance confidence in performing activities of daily living.
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At the beginning and at three months
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FES-I (Falls Efficacy Scale-International)
時間枠：At the beginning and at three months
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Questionnaire that evaluates the fear of falling.
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At the beginning and at three months
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Barthel index
時間枠：At the beginning and at three months
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Measures disability or dependence in activities of daily living
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At the beginning and at three months
|
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KATZ INDEX
時間枠：At the beginning and at three months
|
Is a widely used tool to assess the level of independency in older adults.
|
At the beginning and at three months
|
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FSS (Fatigue Severity Scale)
時間枠：At the beginning and at three months
|
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
|
At the beginning and at three months
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PSQI (Pittsburgh Sleep Quality Index)
時間枠：At the beginning and at three months
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A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
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At the beginning and at three months
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HADS (The Hospital Anxiety And Depression)
時間枠：At the beginning and at three months
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A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non- patients.
|
At the beginning and at three months
|
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SF-36 (The Short Form-36 Health Survey)
時間枠：At the beginning and at three months
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Used extensively for assessing health-related quality of life.
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At the beginning and at three months
|
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MRS (Menopause Rating Scale):
時間枠：At the beginning and at three months
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Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
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At the beginning and at three months
|
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FSFI (Female Sexual Function Index)
時間枠：At the beginning and at three months
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Is a brief questionnaire that evaluates sexual functioning in women.
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At the beginning and at three months
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INBODY
時間枠：At the beginning and at three months
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Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat.
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At the beginning and at three months
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Bone Mineral Content (BMC)
時間枠：At the beginning and at three months
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Is mineral mass in bone.
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At the beginning and at three months
|
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Body Weight
時間枠：At the beginning and at three months
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Is the sum of Body Fat and Fat Free Mass.
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At the beginning and at three months
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Lean Body Mass
時間枠：At the beginning and at three months
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The amount of lean body mass.
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At the beginning and at three months
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Body Fat Mass
時間枠：At the beginning and at three months
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The standard range of Body Fat Mass is ascertained by calculating an examinee Body Fat Mass as compared to the standard weight and standard Body Fat Mass.
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At the beginning and at three months
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Percent of Body Fat (%)
時間枠：At the beginning and at three months
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Indicates the percentage of body fat to body weight.
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At the beginning and at three months
|
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BMI (Body Mass Index)
時間枠：At the beginning and at three months
|
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2.
It is a rough indicator of total body fat.
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At the beginning and at three months
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Segmental Analysis
時間枠：At the beginning and at three months
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Is the technology that assumes the body as five cylinders of four limbs and trunk and measures the impedance of these parts separately.
Segmental body composition analysis provides segmental measurement of body water, muscle mass, and fat free mass.
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At the beginning and at three months
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OPTOGAIT
時間枠：At the beginning and at three months
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Is an innovative system for movement analysis and functional assessment of patients with normal or pathological conditions.
REACTION TEST: This test detects the time between one optical/acoustic impulse and the patient's movement.
It can be used to measure simple reactions or more complex movements
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At the beginning and at three months
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CT10P
時間枠：At the beginning and at three months
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Test that evaluates the balance by walking along a straight line.
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At the beginning and at three months
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STABILOMETRIC PLATFORM
時間枠：At the beginning and at three months
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Instrument composed of resistive pressure sensors, used to measure the static or postural balance.
The test was performed under both eyes-open and eyes-closed conditions.
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At the beginning and at three months
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RMS X
時間枠：At the beginning and at three months
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Mean position of the center of pressure in the mediolateral plane.
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At the beginning and at three months
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RMS Y
時間枠：At the beginning and at three months
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Mean position of the center of pressure in the anteroposterior plane
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At the beginning and at three months
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Length
時間枠：At the beginning and at three months
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Length of the path described by the center of pressure.
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At the beginning and at three months
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Area
時間枠：At the beginning and at three months
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Area of the path described by the center of pressure.
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At the beginning and at three months
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Velocity
時間枠：At the beginning and at three months
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Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test.
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At the beginning and at three months
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Isaac test
時間枠：At the beginning and at three months
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Questionnaire that measures verbal fluency.
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At the beginning and at three months
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trail making test part a y b
時間枠：At the beginning and at three months
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Neuropsychological test of visual attention and task switching.
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At the beginning and at three months
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mmse (mini-mental state examination)
時間枠：At the beginning and at three months
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A tool that can be used to systematically and thoroughly assess mental status.
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At the beginning and at three months
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chair sit and reach test
時間枠：At the beginning and at three months
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To test low back and hamstring flexibility.
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At the beginning and at three months
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back scratch test
時間枠：At the beginning and at three months
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To measure general shoulder range of motion.
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At the beginning and at three months
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30-second chair stand test
時間枠：At the beginning and at three months
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To test leg strength and endurance.
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At the beginning and at three months
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height
時間枠：At the beginning and at three months
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The distance between the lowest and highest points of a person standing upright.
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At the beginning and at three months
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waist circumference
時間枠：At the beginning and at three months
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Is used to assess central fat distribution and degree of abdominal obesity.
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At the beginning and at three months
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hip circumference
時間枠：At the beginning and at three months
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It is the greatest circumference of hip
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At the beginning and at three months
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waist-to-hip ratio
時間枠：At the beginning and at three months
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Is the dimensionless ratio of the circumference of the waist to that of the hips.
This is calculated as waist measurement divided by hip measurement.
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At the beginning and at three months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年8月1日
一次修了 (実際)
2017年11月1日
研究の完了 (実際)
2018年2月27日
試験登録日
最初に提出
2017年6月22日
QC基準を満たした最初の提出物
2017年6月23日
最初の投稿 (実際)
2017年6月28日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月16日
QC基準を満たした最後の更新が送信されました
2021年9月9日
最終確認日
2021年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。