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

Aging Clinical Trial

— PACE  

Official title:

Feasibility Study of Post-hospitalization Interventions to Improve Physical Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203656
• Other study ID #: 13-038
• Secondary ID: 1229
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Placebo
placebo supplement

Dietary Supplement:
• Nutritional Supplement
protein supplement

Behavioral:
• In-home exercise
In-home exercise program

Drug:
• Testosterone
Testosterone injection

Locations

Country	Name	City	State
United States	Jennie Sealy Hospital	Galveston	Texas
United States	UTMB Acute Care for Elders Unit	Galveston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Dairy Research Institute, National Dairy Council

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. 201 — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Follow-up Measures	Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death	1 year post discharge
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood Measures	microRNA levels in blood will be measured	at pre-testing, 1-week post discharge and 4-week post discharge
Secondary	30 day re-hospitalization	re-hospitalization rates will be collected	30 days post-discharge