Clinical trial NCT01115530: Exercise and Nutritional Intervention for Deconditioned Older Adults
Official title: An Exercise and Nutritional Intervention for Deconditioned Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Muscle Weakness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-05-04
Enrollment: 0
Sex: MALE
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Function by the Functional Independence Measure
timeFrame: 12 weeks
Secondary outcomes:
measure: Gait speed
timeFrame: 12 weeks
measure: Lower extremity strength
timeFrame: 12 weeks
Other outcomes:
Locations:
city: No. Little Rock
country: United States
facility: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
state: Arkansas
Study officials:
affiliation: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
name: Patrick Kortebein, MD
role: PRINCIPAL_INVESTIGATOR
References: