Muscle WeaknessNCT01115530
Exercise and Nutritional Intervention for Deconditioned Older Adults
A study testing Resistance exercise and Protein and HMB (see below) supplement in people with Muscle Weakness, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years, men only
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Resistance exercise and Protein and HMB (see below) supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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%;
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706
About this study
Official title: 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.
- Conditions
- Muscle Weakness
- Being tested
- Resistance exercise, Protein and HMB (see below) supplement
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks
Protein and HMB (see below) supplementDietary supplement
Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Resistance exercise |
| 3 | Experimental | Nutritional (amino acid metabolite) supplement twice daily Receives: Dietary Supplement: Protein and HMB (see below) supplement |
| 4 | Experimental | Resistance exercise (2x/week) and nutritional (amino acid metabolite) supplement twice daily Receives: Other: Resistance exercise; Dietary Supplement: Protein and HMB (see below) supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function by the Functional Independence Measure
Measured: 12 weeks
Secondary outcomes (2)
Gait speed
Measured: 12 weeks
Lower extremity strength
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMay 2011
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Insufficient subject recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patrick Kortebein, MD, Principal investigator, Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115530
- Sponsor's protocol ID
- E7142-R
- Status last verified
- Apr 2012
- First submitted
- 25 Feb 2010
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise and Nutritional Intervention for Deconditioned Older Adults
- ClinicalTrials.gov ID
- NCT01115530
- Acronym / sponsor ID
- E7142-R
- Conditions
- Muscle Weakness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient subject recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Resistance exerciseResistance exercise (2x/week) |
| 3 | Experimental | Dietary Supplement: Protein and HMB (see below) supplementNutritional (amino acid metabolite) supplement twice daily |
| 4 | Experimental | Other: Resistance exercise, Dietary Supplement: Protein and HMB (see below) supplementResistance exercise (2x/week) and nutritional (amino acid metabolite) supplement twice daily |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exerciseLower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks | Other | 2, 4 |
| Protein and HMB (see below) supplementIngested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate | Dietary supplement | 3, 4 |
Primary outcome
Function by the Functional Independence Measure
Time frame: 12 weeks
2 secondary outcomes
Gait speed
Time frame: 12 weeks
Lower extremity strength
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Kortebein, MD principal investigator
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise and Protein and HMB (see below) supplement in people with Muscle Weakness, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function by the Functional Independence Measure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2012.