Exercise and Nutritional Intervention for Deconditioned Older Adults

NCT01115530 | Withdrawn DMC

• 1 other identifier: E7142-R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Function by the Functional Independence Measure

  12 weeks

Secondary Outcomes (2)

• Gait speed

  12 weeks

• Lower extremity strength

  12 weeks

Study Arms (4)

1

NO INTERVENTION

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

2

EXPERIMENTAL

Resistance exercise (2x/week)

Other: Resistance exercise

3

EXPERIMENTAL

Nutritional (amino acid metabolite) supplement twice daily

Dietary Supplement: Protein and HMB (see below) supplement

4

EXPERIMENTAL

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

Other: Resistance exercise; Dietary Supplement: Protein and HMB (see below) supplement

Interventions

Resistance exercise OTHER

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

2; 4

Protein and HMB (see below) supplement DIETARY_SUPPLEMENT

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

3; 4

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

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

No. Little Rock, Arkansas, 72114-1706, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Resistance Training; Proteins

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Amino Acids, Peptides, and Proteins

Study Officials

• Patrick Kortebein, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

US (1)