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

NCT02203656 | Completed Phase 1

• 2 other identifiers: 13-0381229
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

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.

Conditions

Aging

Keywords

intervention studies; nutrition; exercise; testosterone; patient readmission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Body Composition

  at pre-testing, 1-week post discharge and 4-week post discharge

• Hand grip strength (kg)

  at pre-testing, 1-week post discharge and 4-week post discharge

• ADLS, IADLS

  at pre-testing, 1-week post discharge and 4-week post discharge

• Physical Activity Levels

  at pre-testing, 1-week post discharge and 4-week post discharge

• Gait Speed (m/s)

  at pre-testing, 1-week post discharge and 4-week post discharge

Other Outcomes (1)

• Follow-up Measures

  1 year post discharge

Study Arms (5)

Placebo Supplement

PLACEBO COMPARATOR

Daily placebo supplement for 30 days after discharge.

Drug: Placebo

Nutritional Supplement

EXPERIMENTAL

Daily nutritional supplement for 30 days after discharge.

Dietary Supplement: Nutritional Supplement

In-home exercise + placebo

EXPERIMENTAL

in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.

Drug: Placebo; Behavioral: In-home exercise

In-home exercise + nutrition

EXPERIMENTAL

in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.

Dietary Supplement: Nutritional Supplement; Behavioral: In-home exercise

Testosterone

EXPERIMENTAL

Single testosterone injection within 24 hours of hospital discharge.

Drug: Testosterone

Interventions

Placebo DRUG

placebo supplement

Also known as: Control

In-home exercise + placebo; Placebo Supplement

Nutritional Supplement DIETARY_SUPPLEMENT

protein supplement

In-home exercise + nutrition; Nutritional Supplement

In-home exercise BEHAVIORAL

In-home exercise program

In-home exercise + nutrition; In-home exercise + placebo

Testosterone DRUG

Testosterone injection

Also known as: Testosterone enanthate

Testosterone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Planned or elective hospitalization within 30 days of discharge
• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Dairy Research Institute: collaborator
• National Dairy Council: collaborator

Study Sites (2)

UTMB Acute Care for Elders Unit

Galveston, Texas, 77550, United States

Location

Jennie Sealy Hospital

Galveston, Texas, 77555, United States

Location

Related Publications (4)

• 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.

  PMID: 27178766 BACKGROUND

• 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.

  PMID: 28591764 RESULT

• 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.

  PMID: 30906944 RESULT

• Arentson-Lantz EJ, Deer RR, Kokonda M, Wen CL, Pecha TA, Carreon SA, Ngyen TM, Volpi E, Nowakowski S. Improvements in sleep quality and fatigue are associated with improvements in functional recovery following hospitalization in older adults. Front Sleep. 2022;1:1011930. doi: 10.3389/frsle.2022.1011930. Epub 2022 Oct 14.

  PMID: 37251511 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Dietary Supplements; Testosterone; testosterone enanthate

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Elena Volpi, MD, PhD

  UTMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: July 30, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 4, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)