Clinical trial NCT02007876: Mobility and Activity Training (MAT) to Optimize Outcomes for Older Adult Abdominal Surgery Patients
Official title: Mobility and Activity Training (MAT) to Optimize Outcomes for Older Adult Abdominal Surgery Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastrointestinal Malignancy
Keywords: Mobility
Activity
Training
Abdominal
Surgery
Adult
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Activity and Strength
timeFrame: 10 weeks
measure: Muscle Mass
timeFrame: 10 weeks
Secondary outcomes:
measure: Effects of Individual MAT Program Segment
timeFrame: 10 weeks
Other outcomes:
measure: Effect of MAT on Surgical Complications
timeFrame: 6 weeks
measure: Effect of MAT on Cost of Care
timeFrame: 6 weeks
measure: Effect of MAT of Operative Symptoms
timeFrame: 6 weeks
measure: Effect of MAT of Hospital Length of Stay
timeFrame: 6 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan-Mobility Research Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan-Taubman Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael J Englesbe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Neil Alexander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Angela E Thelen, BS
role: STUDY_DIRECTOR
References: