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Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ghrelin plus resistance training | Active Comparator | Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training |
|
| Placebo plus resistance training | Placebo Comparator | Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ghrelin | Drug | Ghrelin |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Short Physical Performance Battery (SPPB) | The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12. | Baseline to 12 weeks |
| Treatment-associated Adverse Events | Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin). | Twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Change in weight from baseline to 12 weeks | Baseline to twelve weeks |
| Change in Lean Body Mass | Total lean body mass by dual energy x-ray absorptiometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne R. Cappola, M.D.,Sc.M. | University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Research Center, University of Pennsylvania | Philadelphia | Pennsylvania | 19104-5160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ghrelin Plus Resistance Training | Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights. |
| FG001 | Placebo Plus Resistance Training | Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ghrelin Plus Resistance Training | Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Short Physical Performance Battery (SPPB) | The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ghrelin Plus Resistance Training | Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Cappola, MD | University of Pennsylvania | 215-573-5359 | acappola@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D054439 | Ghrelin |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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| Drug |
Saline will be used as a placebo |
|
| Baseline to 12 weeks |
| Change in Muscle Strength | One repetition max bench press | Baseline to 12 weeks |
| Change in Food Intake | Change in food intake by 3-day food intake record | Baseline to 12 weeks. |
| Change in Quality of Life | Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points | Baseline to 12 weeks. |
| Change in Frailty Status | According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty | Baseline to 12 weeks. |
| BG001 | Placebo Plus Resistance Training | Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo Plus Resistance Training |
Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights. |
|
|
| Primary | Treatment-associated Adverse Events | Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin). | Posted | Number | events | Twelve weeks |
|
|
|
| Secondary | Change in Weight | Change in weight from baseline to 12 weeks | Posted | Mean | Standard Deviation | kg | Baseline to twelve weeks |
|
|
|
| Secondary | Change in Lean Body Mass | Total lean body mass by dual energy x-ray absorptiometry | Posted | Mean | Standard Deviation | kg | Baseline to 12 weeks |
|
|
|
| Secondary | Change in Muscle Strength | One repetition max bench press | Posted | Mean | Standard Deviation | kg | Baseline to 12 weeks |
|
|
|
| Secondary | Change in Food Intake | Change in food intake by 3-day food intake record | Posted | Mean | Standard Deviation | kcal/day | Baseline to 12 weeks. |
|
|
|
| Secondary | Change in Quality of Life | Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks. |
|
|
|
| Secondary | Change in Frailty Status | According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty | Posted | Mean | Full Range | units on a scale | Baseline to 12 weeks. |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo Plus Resistance Training | Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights. | 0 | 11 | 1 | 11 | 0 | 11 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D001519 | Behavior |
| D000602 | Amino Acids, Peptides, and Proteins |