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Exercise and Nutritional Intervention for Deconditioned Older Adults

Primary Purpose

Muscle Weakness

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resistance exercise

Protein and HMB (see below) supplement

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

65 Years - 90 Years (Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

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

Resistance exercise (2x/week)

Nutritional (amino acid metabolite) supplement twice daily

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

Outcomes

Primary Outcome Measures

Function by the Functional Independence Measure

Secondary Outcome Measures

Gait speed

Lower extremity strength

Full Information

NCT ID

NCT01115530

First Posted

February 25, 2010

Last Updated

April 11, 2012

Sponsor

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT01115530

Brief Title

Exercise and Nutritional Intervention for Deconditioned Older Adults

Official Title

An Exercise and Nutritional Intervention for Deconditioned Older Adults

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Insufficient subject recruitment.

Study Start Date

May 2011 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Weakness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

Resistance exercise (2x/week)

Arm Title

Arm Type

Experimental

Arm Description

Nutritional (amino acid metabolite) supplement twice daily

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Resistance exercise

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Protein and HMB (see below) supplement

Intervention Description

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

Primary Outcome Measure Information:

Title

Function by the Functional Independence Measure

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Gait speed

Time Frame

12 weeks

Title

Lower extremity strength

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Kortebein, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

No. Little Rock

State/Province

Arkansas

ZIP/Postal Code

72114-1706

Country

United States

12. IPD Sharing Statement

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Exercise and Nutritional Intervention for Deconditioned Older Adults

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