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

Feasibility Study of Post-hospitalization Interventions to Improve Physical Function

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Drug: Placebo; Dietary supplement: Nutritional Supplement; Behavioral: In-home exercise; Drug: Testosterone

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

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • UTMB Acute Care for Elders Unit
    • Galveston, Texas, United States, 77555
      • Jennie Sealy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Supplement; Daily placebo supplement for 30 days after discharge.	Drug: Placebo; placebo supplement; Other Names: 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 Names: 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 Names: Testosterone enanthate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score	Changes in SPPB score	at pre-testing, 1-week post discharge and 4-week post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention.	at pre-testing, 1-week post discharge and 4-week post discharge
Hand grip strength (kg)	Changes in hand grip will be calculated over duration of study.	at pre-testing, 1-week post discharge and 4-week post discharge
ADLS, IADLS	Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention.	at pre-testing, 1-week post discharge and 4-week post discharge
Physical Activity Levels	Physical activity levels will be measured using a step activity monitor and actiwatch	at pre-testing, 1-week post discharge and 4-week post discharge
Gait Speed (m/s)	Changes in gait speed will be calculated over duration of study.	at pre-testing, 1-week post discharge and 4-week post discharge
Blood Measures	microRNA levels in blood will be measured	at pre-testing, 1-week post discharge and 4-week post discharge
30 day re-hospitalization	re-hospitalization rates will be collected	30 days post-discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up Measures	Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death	1 year post discharge

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Dairy Research Institute; National Dairy Council

Publications and helpful links

General Publications

• Deer RR, Dickinson JM, Fisher SR, Ju H, Volpi E. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial. Contemp Clin Trials. 2016 Jul;49:6-14. doi: 10.1016/j.cct.2016.05.001. Epub 2016 May 10.
• Deer RR, Goodlett SM, Fisher SR, Baillargeon J, Dickinson JM, Raji M, Volpi E. A Randomized Controlled Pilot Trial of Interventions to Improve Functional Recovery After Hospitalization in Older Adults: Feasibility and Adherence. J Gerontol A Biol Sci Med Sci. 2018 Jan 16;73(2):187-193. doi: 10.1093/gerona/glx111.
• Deer RR, Dickinson JM, Baillargeon J, Fisher SR, Raji M, Volpi E. A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1628-1636. doi: 10.1093/gerona/glz084.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: exercise; nutrition; testosterone; intervention studies; patient readmission
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: 13-038; 1229 (Other Grant/Funding Number: Dairy Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No. This is a small Phase 1 pre-pilot study. Risk of loss of confidentiality