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The goal of this clinical trial study is to evaluate the impact of a personalized lifestyle intervention on improving healthspan. The primary questions of interest are whether the personalized intervention will result in improvements in muscle function, immune function, and cognitive function in adults aged 50-85 years. Participants will complete baseline assessments, receive an individualized intervention plan for approximately 3 months, and then complete post-intervention assessments. The intervention includes an exercise plan, nutrition recommendations, and general lifestyle goals that will be personalized to each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | All participants will receive an intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Management | Behavioral | Each subject will receive a personalized intervention plan, comprised of:
|
| Measure | Description | Time Frame |
|---|---|---|
| VO2 max | A maximal treadmill exercise test with respiratory gas exchange analysis to assess cardiorespiratory fitness. | From baseline to the end of the intervention at 3 months. |
| Biodex | A Biodex will be used to assess leg muscle power and strength. | From baseline to the end of the intervention at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life Survey | We will assess quality of life with the WHO_QoL. The WHO_QoL is scored from 0-100 with a higher score indicating a higher quality of life. | From baseline to the end of the intervention at 3 months. |
| Pittsburgh Sleep Quality Index |
| Measure | Description | Time Frame |
|---|---|---|
| Resting metabolic rate | A test to assess how many calories the body burns at rest. RMR will be measured in the fasted state while the participant is supine. | From baseline to the end of the intervention at 3 months. |
| Red Blood Cells |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wexford Innovation Center | Phoenix | Arizona | 85004 | United States |
Primary and secondary outcomes will be shared.
Data will be made available after all data have been collected, entered into the REDCap database, data cleaning procedures have been completed, and the primary articles have been published. Data will be available on or before 1/1/2028 and will remain available for a minimum of 3 years.
The Arizona State University Research Data Repository can be accessed freely by investigators. This data repository has supporting information about the protocol and contact information for the investigative team.
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D012890 | Sleep |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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A pre-post design will be used, with all participants receiving the intervention.
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|
This questionnaire assesses sleep quality. The PSQI is scored on a scale from 0-21 with a higher score indicating higher sleep quality. |
| From baseline to the end of the intervention at 3 months. |
| Handgrip strength | A hand-held dynamometer will be used to measure handgrip strength. | From baseline to the end of the intervention at 3 months. |
| Dual Energy X-ray Absorptiometry (DXA) | A DXA scan will be used to assess body composition and bone mineral density. | From baseline to the end of the intervention at 3 months. |
| Waist circumference | Waist circumference will be measured at the superior border of the iliac crest. | From baseline to the end of the intervention at 3 months. |
| Hip circumference | Hip circumference will be measured at the maximal protrusion of the buttocks. | From baseline to the end of the intervention at 3 months. |
| Systolic blood pressure | Systolic blood pressure will be measured at rest. | From baseline to the end of the intervention at 3 months. |
| Diastolic blood pressure | Diastolic blood pressure will be measured at rest. | From baseline to the end of the intervention at 3 months. |
| Digit Symbol Substitution Test (DSST) | The DSST assesses cognition and cognitive impairment. | From baseline to the end of the intervention at 3 months. |
| Montreal Cognitive Assessment (MoCA) | The MoCA assesses cognition and cognitive impairment. The MoCA is scored out of 30 points and a higher score indicates better cognitive function. | From baseline to the end of the intervention at 3 months. |
| Short Physical Performance Battery | A performance test to assess balance and physical function. | From baseline to the end of the intervention at 3 months. |
| Low Density Lipoprotein Cholesterol | A test assessing calculated LDL cholesterol. | From baseline to the end of the intervention at 3 months. |
| Hemoglobin A1C Concentration | This will assess a participants HbA1C. | From baseline to the end of the intervention at 3 months. |
| Insulin Concentration | This test will assess a participants fasting insulin. | From baseline to the end of the intervention at 3 months. |
| Geriatric Depression Scale (GDS) | This survey assesses feelings of depression in older adults. The GDS is scored from 0-15, with a higher score indicating more feelings of depression. | From baseline to the end of the intervention at 3 months. |
| Generalized Anxiety Disorder (GAD)-7 | This survey assess feelings of anxiety. The GAD-7 is scored from 0-21, with higher scores indicating higher feelings of anxiety. | From baseline to the end of the intervention at 3 months. |
| Perceived Stress Scale | This survey assesses perceived stress. This survey is scored from 0-40 with higher scores indicating higher stress. | From baseline to the end of the intervention at 3 months. |
| High Density Lipoprotein Cholesterol | A blood test measuring HDL cholesterol. | From baseline to the end of the intervention at 3 months. |
| Brief Resilience Scale | This survey assess a participants resilience. This survey is scored from 0-30 with higher scores indicating a higher level of resilience. | From baseline to the end of the intervention at 3 months. |
| Non-High Density Lipoprotein Cholesterol | A blood test measuring non-HDL cholesterol. | From baseline to the end of the intervention at 3 months. |
| Very Low Density Lipoprotein Cholesterol | A blood test measuring VLDL cholesterol. | From baseline to the end of the intervention at 3 months. |
| CD3 T cells | This test will measure how many CD3 Mature T Cells are in the blood. This will be reported as a percentage. | From baseline to the end of the intervention at 3 months. |
| CD4 T cells | This test will measure the CD4 T cells in the blood. This will be reported as a percentage. | From baseline to the end of the intervention at 3 months. |
| CD8 T cells | This test will measure the CD8 T cells in the blood. This will be reported as a percentage. | From baseline to the end of the intervention at 3 months. |
| Natural Killer cells | This test will measure the NK cells in the blood. This will be reported as a percentage. | From baseline to the end of the intervention at 3 months. |
| B cells | This test will measure the B cells in the blood. This will be reported as a percentage. | From baseline to the end of the intervention at 3 months. |
This will assess the number of red blood cells.
| From baseline to the end of the intervention at 3 months. |
| White blood cells | This will assess the number of white blood cells. | From baseline to the end of the intervention at 3 months. |
| Platelets | This will assess the number of platelets in the blood. | From baseline to the end of the intervention at 3 months. |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |