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This study has been withdrawn prior to enrollment.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
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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
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 Food Habits Signs and Symptoms Muscular Diseases |
Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes Habits |
ClinicalTrials.gov processed this record on May 23, 2013