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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This study has been withdrawn prior to enrollment.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

February 25, 2010
April 11, 2012
May 2011
July 2012   (final data collection date for primary outcome measure)
Function by the Functional Independence Measure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01115530 on ClinicalTrials.gov Archive Site
  • Gait speed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Lower extremity strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise and Nutritional Intervention for Deconditioned Older Adults
An Exercise and Nutritional Intervention for Deconditioned Older Adults

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Muscle Weakness
  • 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
  • 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)
    Intervention: Other: Resistance exercise
  • Experimental: 3
    Nutritional (amino acid metabolite) supplement twice daily
    Intervention: Dietary Supplement: Protein and HMB (see below) supplement
  • Experimental: 4
    Resistance exercise (2x/week) and nutritional (amino acid metabolite) supplement twice daily
    Interventions:
    • Other: Resistance exercise
    • Dietary Supplement: Protein and HMB (see below) supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Male
65 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01115530
E7142-R
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Patrick Kortebein, MD Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
Department of Veterans Affairs
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP