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Completed

NCT Number: NCT02203656

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

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jennie Sealy Hospital, Galveston, Texas, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

placebo supplement

Other names: Control

Nutritional Supplement

Dietary Supplement

protein supplement

In-home exercise

Behavioral

In-home exercise program

Testosterone

Drug

Testosterone injection

Other names: Testosterone enanthate

Primary outcomes

  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 outcomes

  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 outcomes

  1. Follow-up Measures

    Time frame: 1 year post discharge

    Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • Dairy Research Institute
  • National Dairy Council

Registry information

Official study title

Feasibility Study of Post-hospitalization Interventions to Improve Physical Function

Acronym: PACE

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 30, 2014
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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