Exercise and Nutritional Intervention for Deconditioned Older Adults

This study has been withdrawn prior to enrollment.
(Insufficient subject recruitment.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01115530
First received: February 25, 2010
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Muscle Weakness
Other: Resistance exercise
Dietary Supplement: Protein and HMB (see below) supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exercise and Nutritional Intervention for Deconditioned Older Adults

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Function by the Functional Independence Measure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait speed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Lower extremity strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control inpatient GEM rehabilitation and continue twice weekly low level walking/stretching to control for time/interaction with intervention/exercise groups
Experimental: 2
Resistance exercise (2x/week)
Other: Resistance exercise
Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks
Experimental: 3
Nutritional (amino acid metabolite) supplement twice daily
Dietary Supplement: Protein and HMB (see below) supplement
Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate
Experimental: 4
Resistance exercise (2x/week) and nutritional (amino acid metabolite) supplement twice daily
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

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115530

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
Investigators
Principal Investigator: Patrick Kortebein, MD Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01115530     History of Changes
Other Study ID Numbers: E7142-R
Study First Received: February 25, 2010
Last Updated: April 11, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthenia
Muscle Weakness
Paresis
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014