Effects of Exercise in People With Tetraplegia
Effects of Exercise on Post-Prandial Lipemia and Fat Oxidation After Tetraplegia
調査の概要
詳細な説明
Much as in the general population, cardiovascular disease (CVD) is a leading cause of death in persons with spinal cord injury. However, CVD occurs earlier in life for those with SCI, progresses silently, and manifests atypical symptoms which fail to warn of impending ischemic damage. This accelerated development of CVD is multimodal in cause, including, but not limited to: a sedentary lifestyle, decreased muscle mass, increased fat mass, and physiologic alterations in lipid metabolism, all attributable in part to SCI. Traditional methods of dietary modification and exercise intervention are likely insufficient to elicit adequate modification of post-SCI physiology to prevent CVD. Secondary to our purposes, but of immediate importance to an individual with SCI is the impact of a sedentary lifestyle and increased obesity on their ability to remain independent. A quarter of young persons with SCI possess levels of fitness which are inadequate to complete essential activities of daily living. Thus, a sedentary lifestyle, as measured by fitness, is a correlate if not perceptive of morbidity and mortality in persons with SCI.
Atherosclerosis has recently been defined as an inflammatory disease. C-reactive protein has emerged as a general marker of inflammation and is elevated in persons with SCI. We have demonstrated persons with SCI have a pathophysiologic lipid uptake response to a high fat meal, the endpoint of which is increased vascular oxidative stress, a precursor to CVD, indexed by endothelial microparticles. We have also demonstrated circuit resistance training favorably alters lipid profiles of persons with paraplegia. Research in able-bodied individuals suggests acute bouts of exercise accelerate postprandial lipid metabolism (PPL). Post-exercise supplementation has been demonstrated to improve gains in both lean muscle mass and performance over exercise alone in both the able-bodied and individuals with spinal cord injury.
Targeting inflammation, post-prandial lipidemia, and altering lipid profiles through dietary and exercise interventions may be a method to reverse or pre-empt the development of CVD in persons with SCI. Increasing muscle mass and physical performance through the same interventions may improve physical performance and thus independence in activities of daily living in persons with SCI. In addition, exercise may serve to decrease depression and anxiety in persons with SCI, much as in non-disabled persons. Targeted exercise plus timed supplementation may decrease the accelerated morbidity and mortality of persons with SCI.
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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Florida
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Miami、Florida、アメリカ、33136
- The Miami Project to Cure Paralysis
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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:
- SCI resulting in tetraplegia at C5-C8
- injury for more than one year
- American Spinal Injury Association Impairment Scale (AIS) grade A-C injuries
Exclusion Criteria:
- Surgery within 6 months;
- pressure ulcer within 3 months;
- upper limb pain that limits completion of exercise;
- recurrent acute infection or illness requiring hospitalization or IV antibiotics;
- pregnancy;
- previous myocardial infarction or cardiac surgery;
- history of glucose-lowering and lipid-lowering drug therapy;
- Type I or II diabetes (by World Health Organization criteria). The following medications and drug therapies will disqualify subjects from participating in the study: beta-adrenergic antagonists, maintenance alpha-adrenergic blockers, Methyldopa, thiazide and loop diuretics, parasympatholytic agents, zinc, estrogen/hormone replacement therapy excluding oral contraceptives, insulin-sensitizing drugs, aspirin, and non-steroidal anti-inflammatory drugs.
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 |
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実験的:Supplement
Participants randomized to the 'supplement' arm will consume a blended drink containing 48g of ionexchange, hydrolyzed vanilla-flavored whey protein (Whey to Go, Solgar Vitamin and Herb, Leonia, NJ; 3g CH2O, < 3g Total Fat).
The drink will be given in split doses immediately before and after each training session, which represents a timing schedule that best stimulates muscle anabolism in persons undergoing exercise training.
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CRT will occur 3 times per week for 26 weeks.
Each session will last approximately 40-45 minutes and employ resistance training (weight lifting) and endurance activities (reciprocal arm exercise, Vita-Glide®, RehaMed International) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).
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プラセボコンパレーター:Placebo
As ingestion of the protein supplement is critically influenced by time of administration, participants assigned to the 'placebo' study arm will consume the identical supplement and dose on days during which training is not performed.
This strategy will allow the groups to be isocaloric and equal in protein supplementation.
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CRT will occur 3 times per week for 26 weeks.
Each session will last approximately 40-45 minutes and employ resistance training (weight lifting) and endurance activities (reciprocal arm exercise, Vita-Glide®, RehaMed International) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).
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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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Area Under the Curve (AUC) for lipemia
時間枠:4 visits over 9 months
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The post-prandial lipemia is assessed by the AUC for triglycerides.
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4 visits over 9 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mark S Nash, PhD、University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
脊髄損傷の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル