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| ID | Type | Description | Link |
|---|---|---|---|
| 1229 | Other Grant/Funding Number | Dairy Research Institute |
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| Name | Class |
|---|---|
| Dairy Research Institute | OTHER |
| National Dairy Council | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Supplement | Placebo Comparator | Daily placebo supplement for 30 days after discharge. |
|
| Nutritional Supplement | Experimental | Daily nutritional supplement for 30 days after discharge. |
|
| In-home exercise + placebo | Experimental | in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge. |
|
| In-home exercise + nutrition | Experimental | in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge. |
|
| Testosterone | Experimental | Single testosterone injection within 24 hours of hospital discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo supplement |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up Measures | Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death | 1 year post discharge |
Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Subjects Randomized to the Testosterone Group
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| Name | Affiliation | Role |
|---|---|---|
| Elena Volpi, MD, PhD | UTMB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTMB Acute Care for Elders Unit | Galveston | Texas | 77550 | United States | ||
| Jennie Sealy Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27178766 | Background | 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. | |
| 28591764 | Result |
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No. This is a small Phase 1 pre-pilot study. Risk of loss of confidentiality
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D013739 | Testosterone |
| C004648 | testosterone enanthate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Nutritional Supplement | Dietary Supplement | protein supplement |
|
| In-home exercise | Behavioral | In-home exercise program |
|
| Testosterone | Drug | Testosterone injection |
|
|
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 |
| Galveston |
| Texas |
| 77555 |
| United States |
| 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. |
| 30906944 | 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. |
| 37251511 | Derived | 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. |
| D000737 |
| Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |