Gastrointestinal Malignancy Clinical Trial
Official title:
Mobility and Activity Training (MAT) to Optimize Outcomes for Older Adult Abdominal Surgery Patients
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care