Exercise and Nutritional Intervention for Deconditioned Older Adults

Study Overview
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Brief Summary
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In this study we will evaluate whether the addition of a formal lower extremity resistance exercise training program and/or a nutritional supplement will improve the functional recovery of older adult veterans participating in a geriatric rehabilitation program for deconditioning. Specifically, subjects admitted to a geriatric inpatient rehabilitation program with a diagnosis of deconditioning will be randomly assigned to one of four groups; 1) Control/standard rehabilitation program, 2) Standard rehabilitation plus resistance exercise twice per week, 3) Standard rehabilitation plus a daily nutritional supplement, 4) Standard rehabilitation plus the resistance exercise and the nutritional supplement. Subjects will participate in each program for 12 weeks. At the beginning and end of the study we will measure lower extremity strength, walking speed, and overall function (using the standardized Functional Independence Measure), and compare the changes in each group.

Official Title
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An Exercise and Nutritional Intervention for Deconditioned Older Adults

Conditions
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Muscle Weakness

Intervention / Treatment
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* Other: Resistance exercise
* Dietary Supplement: Protein and HMB (see below) supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran admitted to GEM rehabilitation unit Primary problem: Deconditioning/Generalized Weakness Age 65-90 Self reported ability to report to the CAVHS GRECC twice per week after discharge from the GEM unit. Living in the community prior to recent acute care hospitalization Decision making capacity to be able to consent to the study as documented in the GEM attending or GEM APN's admission note Exclusion Criteria: Conditions that are exclusionary criteria for GEM admission including the following: direct transfer from any ICU, end-stage chronic medical/surgical disorder with no rehabilitation potential, terminal diagnosis /hospice/respite care, hemodialysis, active radiation therapy. Also, Type I diabetes mellitus Any other condition considered exclusionary by the PI / study physician. Prior to group assignment, subjects will be evaluated for contraindications to exercise training per the American College of Sports Medicine (ACSM)guidelines including the following: Myocardial infarction documented in the past 3 months Unstable angina (at rest in past 3 months, or increased angina pattern in past month) Uncorrected left main coronary obstruction > 50%; Congestive heart failure exacerbation in past 3 months (symptoms at rest or worsening symptoms requiring change in baseline diuretic dose) Severe valvular heart disease (aortic or mitral stenosis with valve area < 1 cm2 , mitral or aortic insufficiency with any degree of LV dysfunction, pulmonary hypertension [PASP > 50 mmHg], or LV enlargement [LVESD 40 mm, or LVEDD > 55 mm]) Active pericarditis / myocarditis Malignant or unstable arrhythmias, third degree AV block without pacemaker Elevated resting blood pressure (systolic > 200 mmHg, diastolic > 110 mmHg) Known large (> 4 cm) aortic aneurysm Known cerebral aneurysm or intracranial bleed in past 1 year Terminal cancer Acute retinal hemorrhage or ophthalmologic surgery within 3 months

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Control inpatient GEM rehabilitation and continue twice weekly low level walking/stretching to control for time/interaction with intervention/exercise groups | |
| Experimental: 2<br>Resistance exercise (2x/week) | Other: Resistance exercise<br>* Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks<br>|
| Experimental: 3<br>Nutritional (amino acid metabolite) supplement twice daily | Dietary Supplement: Protein and HMB (see below) supplement<br>* Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate<br>|
| Experimental: 4<br>Resistance exercise (2x/week) and nutritional (amino acid metabolite) supplement twice daily | Other: Resistance exercise<br>* Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks<br>Dietary Supplement: Protein and HMB (see below) supplement<br>* Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function by the Functional Independence Measure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed |  | 12 weeks | 
| Lower extremity strength |  | 12 weeks |