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

Withdrawn before enrolling · Not applicable

Conditions studied: Gastrointestinal Malignancy

In brief

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.

Key facts

Study ID

NCT02007876

Run by

University of Michigan

People needed

0

Starts

2013-06-01

Expected to finish

2016-01-01

Last updated by the study team

2016-02-03

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Michigan-Mobility Research Center — Ann Arbor, Michigan, United States
• University of Michigan-Taubman Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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