Efficacy of an Intervention to Prevent Frailty in Obese Elderly People (PRE-FROB) (PRE-FROB)
Efficacy of a Multimodal Intervention in the Prevention of Frailty in Obese Elderly People and Study of the Pathophysiological Mechanisms Involved
Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese people usually perform less physical activity. All this favors the loss of mass and muscular function (sarcopenia), a key component of the fragility and the functional deterioration.
Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the prevention of frailty in obese elderly people, as well as to know the main mechanisms involved in the frailty process.
Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of age, obese (BMI ≥30), without criteria of fragility and living in the community. Study intervention: multimodal and personalized intervention with the support of a "personal trainer" that has two main axes of action: a) diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls and b) physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months. Main outcome measures (to be evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia (according to the criteria of the European Working Group on Sarcopenia in Older People -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in body composition and distribution of body fat, c) glycemic control (HbA1) and insulin resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Barcelona
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Mataró、Barcelona、スペイン、08304
- Consorci Sanitari del Maresme
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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:
- BMI between 30 and 39 kg / m2
- Non Frail according to L. Fried criteria
At least one of the following diagnoses:
- Oral glucose intolerance or type 2 diabetes without insulin therapy.
- Dyslipidemia (cholesterolemia> 200 mg / dl or triglyceridemia> 150 mg / dl)
- Arterial hypertension (AT> 120/90 mm Hg)
- Relevant physical limitations due to obesity
- Sleep apnea-hypopnea syndrome (SAHS)
- Give written informed consent to participate in the study.
Exclusion Criteria:
- Dementia or other neurodegenerative diseases (Parkinson's disease)
- Neuromuscular diseases
- Severe psychiatric illness that, at the discretion of the physician, prevents good compliance with the study intervention
- Active cancer
- Life expectancy less than 6 months
- Hemiplegia secondary to stroke
- Amputation of a member
- Bariatric surgery tributary patient
- Institutionalized patient
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Intervention
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Diet and physical exercises
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介入なし:Control
Clinical practise
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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 |
---|---|---|
Frailty
時間枠:two years
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Frailty by L Fried criteria
|
two years
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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 |
---|---|---|
Sarcopenia
時間枠:two years
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Sarcopenia by European Working Group on Sarcopenia in Older People criteria
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two years
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
Interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない