Strength Training for Skeletal Muscle Adaptation After Stroke
調査の概要
詳細な説明
This study investigates the hypothesis that a novel, high intensity, high repetition ST program will improve abnormalities in paretic and non-paretic leg muscle volume and composition compared to an attention-matched control regimen of supervised stretching over a 3-month intervention period in those disabled by stroke. The investigators further hypothesize that ST-induced skeletal muscle adaptation will translate into improved insulin sensitivity, strength, and function in this population. The specific objectives are to: 1) Determine the effects ST compared to a control intervention on paretic and non-paretic abnormalities in skeletal muscle volume, intramuscular fat, muscle fiber distribution, muscle capillary density, and muscle inflammation in chronically disabled stroke survivors. 2) Determine the effects ST compared to a control intervention on insulin sensitivity in stroke survivors, and whether structural and cellular skeletal muscle mechanisms contribute to improvements in insulin sensitivity after ST. 3) Determine the effects ST compared to a control intervention on physical function (strength, walking speed and balance) in stroke survivors, and whether structural skeletal muscle mechanisms predict ST-induced functional improvement.
The project design consists of 4 phases over 5 months for stroke participants enrolled in either of the two intervention arms (ST vs. CONTROL). During phase 1 the investigators will screen and consent chronic stroke patients with residual gait deficits. Phase 2 (3 weeks) will consist of baseline testing that includes dual energy X-ray absorptiometry (DEXA) scanning, bilateral CT scanning of the legs, bilateral vastus lateralis muscle biopsies, strength testing, timed walks, balance measurements, oral glucose tolerance testing, and hyperglycemic clamp testing. Following completion of baseline testing, volunteers are to be randomized to ST or the CONTROL group. Phase 3 (Intervention Phase, 3 months) will begin with 2 sessions of acclimatization for those assigned to the ST group. ST will then be progressed to 2 sets of 20 repetitions on each leg on each machine (Keiser Leg Press, Leg Extension, Leg Curl) with gradual increases in resistance over 3 months. Those in the CONTROL group will receive equal exposure to health care personnel in the Baltimore VA Exercise facility, performing a full battery of upper and lower body passive and active stretching exercises at each intervention session. In Phase 4 all baseline testing and laboratory analyses will be repeated.
Developing evidence-based therapies to combat skeletal muscle deterioration is highly relevant for chronically disabled stoke survivors. There is mounting evidence that current models of post-stroke rehabilitation are not optimal for maximizing recovery of muscle mass, strength, and metabolic health. The proposed research will develop new insight into the utility of progressive ST for reversing detrimental changes to gross muscle composition, muscle molecular phenotype, muscle inflammation, and muscle capillarization. Changes to any or all of these muscle parameters should have measurable impact on both whole body insulin sensitivity and function. Collectively, the results from this trial may change the current standard of care for stroke survivors by providing evidenced reasons for augmenting physical therapists' treatments, allowing more intense and diverse therapy sessions for maintenance of skeletal muscle.
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
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
-
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:
- Stroke greater than 6 months prior with residual hemiparetic gait in women or men aged 40-85 years
- Completion of all regular post-stroke physical therapy
- Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent
Exclusion Criteria:
- Alcohol consumption greater than 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report
clinical history of:
- unstable angina
- recent (less than 3 months) myocardial infarction or congestive heart failure (NYHA category II)
- hemodynamically significant valvular dysfunction
- peripheral arterial occlusive disease (PAOD) with claudication
- major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise
- pulmonary or renal failure
- poorly controlled hypertension (greater than 190/110)
- recent hospitalization for severe disease or surgery
- severe or global receptive aphasia which confounds reliable testing and training
- Allergy to lidocaine
- Known muscle disorder
- Taking Coumadin or Lovenox (contraindication for muscle biopsies)
- Dementia
- Untreated major depression
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: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: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:Arm 1
Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl).
Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour.
Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
|
3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.
|
アクティブコンパレータ:Arm 2
Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week).
Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
|
3x per week upper and lower body stretching mixed with active and passive range of motion exercises
|
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 |
---|---|---|
Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)
時間枠:Baseline, 3 months
|
Baseline, 3 months
|
|
Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)
時間枠:Baseline, 3 months
|
Baseline, 3 months
|
|
Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)
時間枠:Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)
時間枠:Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in Leg Muscle Endurance (Paretic Side)
時間枠:Baseline, 3 Months
|
Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).
|
Baseline, 3 Months
|
Change in Leg Muscle Endurance (Non-Paretic Side)
時間枠:Baseline, 3 months
|
Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).
|
Baseline, 3 months
|
Change in 6-minute Walk Distance
時間枠:Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in 10 Meter Walking Speed (Self-Selected)
時間枠:Baseline, 3 months
|
Baseline, 3 months
|
|
Change in 10 Meter Walking Speed (Fastest)
時間枠:Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in Peak Aerobic Capacity (VO2 Peak)
時間枠:Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in Berg Balance Scale
時間枠:Baseline, 3 months
|
This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points.
Range is 0-56 and higher values represent a better outcome.
|
Baseline, 3 months
|
Change in Paretic Limb Step Time (Self-Selected)
時間枠:Baseline, 3 months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 months
|
Change in Paretic Limb Step Time (Fastest)
時間枠:Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Non-Paretic Limb Step Time (Self-Selected)
時間枠:Baseline, 3 months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 months
|
Change in Non-Paretic Limb Step Time (Fastest)
時間枠:Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Paretic Limb Step Length (Self-Selected)
時間枠:Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Paretic Limb Step Length (Fastest)
時間枠:Baseline, 3 months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 months
|
Change in Non-Paretic Limb Step Length (Self-Selected)
時間枠:Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Non-Paretic Limb Step Length (Fastest)
時間枠:Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Ivey FM, Prior SJ, Hafer-Macko CE, Katzel LI, Macko RF, Ryan AS. Strength Training for Skeletal Muscle Endurance after Stroke. J Stroke Cerebrovasc Dis. 2017 Apr;26(4):787-794. doi: 10.1016/j.jstrokecerebrovasdis.2016.10.018. Epub 2016 Nov 16.
- Ivey FM, Ryan AS. Resistive training improves insulin sensitivity after stroke. J Stroke Cerebrovasc Dis. 2014 Feb;23(2):225-9. doi: 10.1016/j.jstrokecerebrovasdis.2012.12.014. Epub 2013 Jan 22.
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。
Exercise- Strength Trainingの臨床試験
-
University of British ColumbiaSocial Sciences and Humanities Research Council of Canada; Michael Smith Foundation for Health... と他の協力者完了
-
University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg完了
-
Shanghai Jiao Tong University School of Medicine積極的、募集していない
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者完了
-
University of MinnesotaNational Institute of Mental Health (NIMH)募集精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
-
VA Office of Research and Development募集