Exercise and Nutritional Intervention for Deconditioned Older Adults

Muscle Weakness Clinical Trial

Official title:

An Exercise and Nutritional Intervention for Deconditioned Older Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01115530
• Other study ID #: E7142-R
• Status: Withdrawn
• Phase: N/A
• First received: February 25, 2010
• Last updated: April 11, 2012
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Intervention

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

Dietary Supplement:
• Protein and HMB (see below) supplement
Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate

Locations

Country	Name	City	State
United States	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	No. Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function by the Functional Independence Measure		12 weeks	No
Secondary	Gait speed		12 weeks	No
Secondary	Lower extremity strength		12 weeks	No