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

NCT02007876 | Withdrawn DMC

• 1 other identifier: HUM00062864
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastrointestinal Malignancy

Keywords

Mobility; Activity; Training; Abdominal; Surgery; Adult

Outcome Measures

Primary Outcomes (2)

• Functional Activity and Strength

  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

  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

Secondary Outcomes (1)

• Effects of Individual MAT Program Segment

  10 weeks

Other Outcomes (4)

• Effect of MAT on Surgical Complications

  6 weeks

• Effect of MAT on Cost of Care

  6 weeks

• Effect of MAT of Operative Symptoms

  6 weeks

Study Arms (2)

Mobility and Activity Training

EXPERIMENTAL

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.

Behavioral: Mobility and Activity Training

Normal activity

NO INTERVENTION

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.

Interventions

Mobility and Activity Training BEHAVIORAL

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.

Mobility and Activity Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

University of Michigan-Mobility Research Center

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan-Taubman Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael J Englesbe, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Neil Alexander, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Angela E Thelen, BS

  University of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: December 11, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-01

Locations

US (2)