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Mobility and Activity Training (MAT) to Optimize Outcomes for Older Adult Abdominal Surgery Patients (MAT)

2016年2月1日 更新者:Michael Englesbe、University of Michigan
In this pilot study a group of older adults undergoing midline laparotomy for gastrointestinal malignancy will participate in a mobility and activity training (MAT) program. MAT is designed to advance functional mobility and physical activity and spans the pre-operative, inpatient, and post-operative period. Patients undergoing abdominal surgery will be randomized to MAT versus control usual care and evaluated at their first appointment 4 weeks preoperatively (baseline), immediately prior to surgery, on hospital discharge, and 6 weeks post operatively. We hope to prove that abdominal surgery patients undergoing MAT will show less decline and earlier recovery in functional activity, and trunk and thigh muscle strength mass. This study is uniquely innovative in that it links functional activity assessment and training and analysis of trunk morphomics (muscle mass) in exploring mechanisms of post-operative recovery. Results from this pilot will be used to determine an effect size for the recruitment of a larger cohort and to study key surgical outcomes, including surgical complications, operative symptoms, hospital length of stay, and cost of care.

調査の概要

状態

引きこもった

詳細な説明

Older and sicker patients are at increased risk of poor surgical outcomes, with more complications, longer lengths of stay, more utilization of skilled nursing facilities, increased mortality, and high costs when compared with younger and healthier patients undergoing similar procedures. In addition, more high-risk patients are having surgery, as overall surgical volumes are predicted to increase up to 47% (from 2000 to 2020). Within this context, efforts to improve surgical quality among high-risk patients have become of paramount importance and new proven strategies to improve surgical outcomes are needed.

Work by the PI Englesbe suggests that trunk muscle lean mass is strongly associated with poor surgical outcomes, suggesting an independent link between muscle loss (sarcopenia) and surgical outcome, even when controlling for comorbidity and functional impairment. Furthermore, their work notes that trunk muscle mass declines rapidly in the peri-operative period. Whether exercise interventions can remediate this risk is unknown. Few randomized control trials exist that address whether pre-operative exercise interventions can alter eventual post-operative outcomes, and none focus on training the trunk musculature in abdominal surgery patients. Further, trunk musculature is critical for mobilization and several published trials (such as in an intensive care unit) suggest that early mobilization is associated with improved outcomes. Thus, the link between reduction in muscle loss via exercise and improved mobility in post-surgical patients remains to be proven but seems promising. Co-PI Alexander has extensive experience in studies of mobility task assessment and enhancement in able and disabled adults. Of particular relevance to the present proposal are studies of rising from a bed (supine to sit) and from a chair (sit to stand) and the improvement that can be noted, using a task-specific approach in older adults at risk for mobility impairment. His most recent funded investigations focus on home-based mobility and physical activity enhancement.

We propose to pilot study a group of older adults undergoing midline laparotomy for gastrointestinal malignancy and who participate in a mobility and activity training (MAT) program. MAT is designed to advance functional mobility and physical activity and spans the pre-operative, inpatient, and post-operative period. Patients undergoing abdominal surgery will be randomized to MAT versus control usual care and evaluated at their first appointment 4 weeks preoperatively (baseline), immediately prior to surgery, on hospital discharge, and 6 weeks post operatively. We hope to prove that abdominal surgery patients undergoing MAT will show less decline and earlier recovery in functional activity, and trunk and thigh muscle strength mass. This study is uniquely innovative in that it links functional activity assessment and training and analysis of trunk morphomics (muscle mass) in exploring mechanisms of post-operative recovery. Results from this pilot will be used to determine an effect size for the recruitment of a larger cohort and to study key surgical outcomes, including surgical complications, operative symptoms, hospital length of stay, and cost of care.

Primary Aim 1: To determine the changes in extent of decline and in recovery of functional activity, strength, and muscle mass resulting from activity training (MAT) Primary hypothesis: Abdominal surgery patients randomized to MAT, as opposed to usual care controls (UC) and compared to their baseline evaluation 4 weeks pre-operatively, will have reduced loss of functional activity and reduced loss of muscle strength and mass in the trunk and thigh 6 weeks post-operatively.

Secondary Aim 1: To determine the effects of individual MAT program segments provided pre-operatively, in-hospital, and post-hospital discharge Secondary hypothesis: Abdominal surgery patients randomized to MAT, as opposed to UC, will have reduced loss of functional activity and reduced loss of muscle strength and mass in the trunk and thigh when comparing 1) baseline versus surgical admission; 2) surgical admission versus hospital discharge; and 3) hospital discharge versus post-operative follow-up at 6 weeks.

Exploratory Aim: To determine the effect of MAT on surgical complications, operative symptoms, hospital length of stay and peri-operative cost.

Exploratory hypothesis: Abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have reduced surgical complications, fewer operative symptoms, shorter hospital length of stay, and lower cost of care.

研究の種類

介入

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

    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109
        • University of Michigan-Mobility Research Center
      • Ann Arbor、Michigan、アメリカ、48109
        • University of Michigan-Taubman Center

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

60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

全て

説明

Inclusion Criteria:

  • Elective laparotomy for GI malignancy (colon resection, pancreatic resection, hepatectomy, resection of the bile ducts)
  • Complete surgical resection (surgery on presumed cancer considered resectable by the attending surgeon.

Exclusion Criteria:

  • Presumed benign disease as the indication for surgical resection.
  • Received neo-adjuvant chemotherapy or radiation.
  • Having preoperative severe hypo-albuminemia (albumin less than 3.0 g/dL).
  • Having a previous ventral hernia repair or abdominal wall reconstruction.
  • Morbid obesity (BMI>40)
  • Participating in intensive (30 min per day) aerobic exercise program three times per week.
  • Ongoing physical therapy in a relevant area (e.g. leg strengthening, balance and gait training)
  • Myocardial infarction < 1 month
  • Active symptoms of heart failure (NYHA grade II or higher)
  • Atrial fibrillation with poor rate control (particularly during exercise) or high grade AV block
  • Symptomatic obstructive valvular disease (primarily during exercise)
  • Significant COPD
  • Brittle diabetes (type I diabetes or multiple hypoglycemic episodes requiring assistance)
  • Significant anemia (Hgb<7.0)
  • Substantial dementia (Folstein Mini Mental State Examination <24 our of 30)
  • Blood tests suggesting severe renal impairment (Cr>3.0)
  • Alcohol intake >3oz/day
  • Hemiplegia or lower limb amputation
  • Acute medical conditions, such as acute flare-up of joint condition or infection
  • Significant orthopedic or musculoskeletal condition that limits weight bearing activities
  • Chronic pain syndrome affecting truncal areas (e.g. fibromyalgia)
  • Unable to safely stand and walk, either with or without an assistive device

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:支持療法
  • 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:Mobility and Activity Training

Pre-operative: Participants will receive weekly sessions of higher level, task-specific transfer training. All MAT participants will learn the GCS set of exercises chosen to activate core muscles and lessen decline in core strength. These sessions will be supplemented by a home-based walking and physical activity enhancement program of the participants' choosing, focusing on attaining a safe community-based rate of perceived exertion. A pedometer and home exercise log will be used to encourage compliance and advance activities.

Post-operative: Participants will be screened by physical therapy for standard physical therapy with focus on early mobilization. The GCS exercises taught pre-operatively will be reinstituted.

Post-discharge/home: Participants will continue the GCS program and begin to return to elements of their pre-operative home-based MAT program. The program physical therapist will call weekly to review progress.

Pre-operative: Transfer training: bed and chair transferring exercises rising with and without use of hand assistance including supine to sit in or to the side in bed, and sit to stand from a normal and low height chair. GCS exercises: 1) supine pelvic bracing with transverse abdominal recruitment 2) hip bridges with abductor squeeze 3) supine bent leg abduction with light theraband and 4) supine isometric core and pelvic stabilization with legs flexed and shoulder flexion to raise arms over head with advancement to using theraband. For patients able to stand safely 5) standing mini squats against the wall.

Post-operative: Early mobilization to include standard physical therapy techniques to enhance bed mobility, facilitated sit to stand and walking with therapist assist as needed. All GCS exercises begin 24 hr post op with goal of 5-10 reps and progressing to 3 sets of 10 reps. Participants will be encouraged to move from a roll to the side first supine to sit strategy by week 2.

介入なし:Normal activity

Pre-operative: Participants will be given the National Institute on Aging guide to home-based exercise but no further instruction or incentive for walking or physical activity enhancement.

Post-operative: Participants will be screened by in-hospital physical therapy for standard physical therapy with focus on early mobilization. Those who do not receive physical therapy will not be given any additional training, as is standard for reimbursed hospital services.

Post-discharge: Program nurse will call weekly to provide health education but no instruction or incentives for mobility or physical activity enhancement.

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
Functional Activity and Strength
時間枠:10 weeks
Participants randomized to MAT, as opposed to usual care controls (UC), will undergo physical therapy training as described in the intervention arm. The physical therapy will be used to assess functional activity and strength. Patients randomized into the MAT group will be compared to their baseline evaluation 4 weeks pre-operatively and the patients randomized into the UC group. We predict MAT study participants will have reduced loss of functional activity and reduced loss of muscle strength 6 weeks post-operatively.
10 weeks
Muscle Mass
時間枠:10 weeks
Abdominal surgery patients will undergo 3-4 CT scans at baseline, pre-operatively, at hospital discharge, and at 6 weeks post-operatively. The CT scans will be used to measure changes in muscle mass. We predict MAT study participants will have reduced loss of muscle strength and mass in the trunk and thigh 6 weeks post-operatively.
10 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Effects of Individual MAT Program Segment
時間枠:10 weeks
We hope to determine the effects of the individual MAT program segments provided pre-operatively, in-hospital, and at post-hospital discharge. Using the CT scans and physical therapy training and assessments, we will compare muscle mass and strength between each individual segment of the program. We predict that abdominal surgery patients randomized to MAT, as opposed to UC, will have reduced loss of functional activity and reduced loss of muscle strength and mass in the trunk and thigh when comparing 1) baseline versus surgical admission; 2) surgical admission versus hospital discharge; and 3) hospital discharge versus post-operative follow-up at 6 weeks.
10 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Effect of MAT on Surgical Complications
時間枠:6 weeks
An additional exploratory aim of this study is to determine the effect of MAT on surgical complications. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have reduced surgical complications.
6 weeks
Effect of MAT on Cost of Care
時間枠:6 weeks
An additional exploratory aim of this study is to determine the effect of MAT on peri-operative cost. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have lower cost of care
6 weeks
Effect of MAT of Operative Symptoms
時間枠:6 weeks
An additional exploratory aim of this study is to determine the effect of MAT on operative symptoms. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have fewer operative symptoms.
6 weeks
Effect of MAT of Hospital Length of Stay
時間枠:6 weeks
An additional exploratory aim of this study is to determine the effect of MAT on hospital length of stay. We predict that abdominal surgery patients randomized to peri-operative MAT, as opposed to UC, will have shorter hospital length of stay.
6 weeks

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

捜査官

  • 主任研究者:Neil Alexander, MD、University of Michigan
  • 主任研究者:Michael J Englesbe, MD、University of Michigan
  • スタディディレクター:Angela E Thelen, BS、University of Michigan

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

2013年6月1日

一次修了 (実際)

2016年1月1日

研究の完了 (実際)

2016年1月1日

試験登録日

最初に提出

2013年10月31日

QC基準を満たした最初の提出物

2013年12月6日

最初の投稿 (見積もり)

2013年12月11日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年2月3日

QC基準を満たした最後の更新が送信されました

2016年2月1日

最終確認日

2016年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • HUM00062864

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。

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