Exercise and Nutritional Intervention for Deconditioned Older Adults

NCT ID: NCT01115530

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

Conditions

Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Control inpatient GEM rehabilitation and continue twice weekly low level walking/stretching to control for time/interaction with intervention/exercise groups

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Resistance exercise (2x/week)

Group Type: EXPERIMENTAL

Resistance exercise

Intervention Type: OTHER

Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks

3

Nutritional (amino acid metabolite) supplement twice daily

Group Type: EXPERIMENTAL

Protein and HMB (see below) supplement

Intervention Type: DIETARY_SUPPLEMENT

Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate

4

Resistance exercise (2x/week) and nutritional (amino acid metabolite) supplement twice daily

Group Type: EXPERIMENTAL

Resistance exercise

Intervention Type: OTHER

Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks

Protein and HMB (see below) supplement

Intervention Type: DIETARY_SUPPLEMENT

Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate

Interventions

Resistance exercise

Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks

Intervention Type: OTHER

Protein and HMB (see below) supplement

Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Kortebein, MD

Role: PRINCIPAL_INVESTIGATOR

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

Locations

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

E7142-R

Identifier Type: -

Identifier Source: org_study_id