Purpose

The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Admitted to the UTMB hospital
  • 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
  • Alert and oriented x3 by a physician on H&P.
  • Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.

Exclusion Criteria

  • A Nursing home resident or hospice care patient
  • Uncontrolled blood pressure (systolic >170, or diastolic > 100)
  • New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)
  • End stage renal disease
  • AST/ALT 2.5 times above the normal limit
  • Recent (within 3 months) or current treatment with anabolic steroids.
  • History of 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)
  • Hematocrit ≥ 50%
  • Any other condition or event considered exclusionary by the PI and faculty physician

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Placebo Supplement Placebo Injection
  • Other: Placebo Injection
    Other names:
    • saline
  • Other: Placebo supplement
    Other names:
    • maltodextrin
Experimental
Testosterone
Placebo Supplement Testosterone Injection
  • Drug: Testosterone
    Other names:
    • testosterone enanthate
  • Other: Placebo supplement
    Other names:
    • maltodextrin
Experimental
Protein Supplement
Protein Supplement Placebo Injection
  • Dietary Supplement: Protein Supplement
    Other names:
    • whey protein
  • Other: Placebo Injection
    Other names:
    • saline
Experimental
Protein Supplement + Testosterone
Protein Supplement Testosterone Injection
  • Drug: Testosterone
    Other names:
    • testosterone enanthate
  • Dietary Supplement: Protein Supplement
    Other names:
    • whey protein

Recruiting Locations

Jennie Sealy Hospital
Galveston, Texas 77555
Contact:
Rachel R Deer, PhD
409-266-9640
rrdeer@utmb.edu

More Details

NCT ID
NCT02990533
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Rachel R Deer, PhD
4092669640
rrdeer@utmb.edu

Detailed Description

The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.