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Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults (PACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203656
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Dairy Research Institute
National Dairy Council
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization.

Condition or disease Intervention/treatment Phase
Aging Drug: Placebo Dietary Supplement: Nutritional Supplement Behavioral: In-home exercise Drug: Testosterone Phase 1

Detailed Description:
The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Feasibility Study of Post-hospitalization Interventions to Improve Physical Function
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Supplement
Daily placebo supplement for 30 days after discharge.
Drug: Placebo
placebo supplement
Other Name: Control

Experimental: Nutritional Supplement
Daily nutritional supplement for 30 days after discharge.
Dietary Supplement: Nutritional Supplement
protein supplement

Experimental: In-home exercise + placebo
in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.
Drug: Placebo
placebo supplement
Other Name: Control

Behavioral: In-home exercise
In-home exercise program

Experimental: In-home exercise + nutrition
in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.
Dietary Supplement: Nutritional Supplement
protein supplement

Behavioral: In-home exercise
In-home exercise program

Experimental: Testosterone
Single testosterone injection within 24 hours of hospital discharge.
Drug: Testosterone
Testosterone injection
Other Name: Testosterone enanthate




Primary Outcome Measures :
  1. Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score [ Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge ]
    Changes in SPPB score


Secondary Outcome Measures :
  1. Body Composition [ Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge ]
    Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention.

  2. Hand grip strength (kg) [ Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge ]
    Changes in hand grip will be calculated over duration of study.

  3. ADLS, IADLS [ Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge ]
    Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention.

  4. Physical Activity Levels [ Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge ]
    Physical activity levels will be measured using a step activity monitor and actiwatch

  5. Gait Speed (m/s) [ Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge ]
    Changes in gait speed will be calculated over duration of study.

  6. Blood Measures [ Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge ]
    microRNA levels in blood will be measured

  7. 30 day re-hospitalization [ Time Frame: 30 days post-discharge ]
    re-hospitalization rates will be collected


Other Outcome Measures:
  1. Follow-up Measures [ Time Frame: 1 year post discharge ]
    Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to the University of Texas Medical Branch (UTMB) ACE unit with an admitting diagnosis of congestive heart failure, respiratory infection, kidney/urinary tract infection, or metabolic disorder; or other condition that will allow a subject to participate in the study after patient review
  • Aged 65 years or older
  • Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
  • Lives within 30 miles of UTMB
  • Can stand without assistance at the time of pretesting
  • Presents no medical contraindication to wearing a loose fitting velcro strap for the accelerometer on one ankle
  • Score ≥26 on the 30-item Mini Mental State Examination or alert and oriented X3 by physician on H&P
  • Is discharged "to home" at ACE unit discharge.

Exclusion Criteria:

  • Nursing home resident or hospice patient
  • Uncontrolled blood pressure (systolic >150, or diastolic > 100)
  • History of stroke with motor disability
  • Glomerular filtration rate (GFR) <30 mL/min/1.73m2 or evidence of kidney disease or failure
  • Liver disease ( aspartate aminotransferase (AST) /Alanine transaminase (ALT) 2 times above the normal limit, hyperbilirubinemia)
  • Recent (within 3 months) treatment with anabolic steroids
  • Any other condition or event considered exclusionary by the PI and faculty physician
  • Planned or elective hospitalization within 30 days of discharge

Additional Exclusion Criteria for Subjects Randomized to the Testosterone Group

  • Breast or prostate cancer
  • Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml
  • PSA ≥ 3 ng/ml in men at high risk of prostate cancer, such as African Americans or men with first-degree relatives with prostate cancer
  • Hematocrit ≥ 50%
  • Decompensated heart failure as determined by a physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203656


Locations
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United States, Texas
UTMB Acute Care for Elders Unit
Galveston, Texas, United States, 77550
Jennie Sealy Hospital
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Dairy Research Institute
National Dairy Council
Investigators
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Principal Investigator: Elena Volpi, MD, PhD UTMB
Publications of Results:
Other Publications:
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02203656    
Other Study ID Numbers: 13-038
1229 ( Other Grant/Funding Number: Dairy Research Institute )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No. This is a small Phase 1 pre-pilot study. Risk of loss of confidentiality
Keywords provided by The University of Texas Medical Branch, Galveston:
intervention studies
nutrition
exercise
testosterone
patient readmission
Additional relevant MeSH terms:
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Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents