Personalized Approach to Promote Healthy Aging

Not Applicable

Recruiting

• Conditions: Aging; Aging, Healthy

• Registration Number: NCT06734468
• Lead Sponsor: Arizona State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-07
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 50-85 years of age
• Non-smoking
• Ambulatory without the need of an assistive device (walker, cane, etc.) and able to perform exercise testing and exercise training
• English speaking
• Owns a smart phone

Exclusion Criteria

• Minors and adults younger than age 50 years and older than 85 years
• Pregnant women
• Adults who are unable to provide informed consent
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
VO2 max	From baseline to the end of the intervention at 3 months.	A maximal treadmill exercise test with respiratory gas exchange analysis to assess cardiorespiratory fitness.
Biodex	From baseline to the end of the intervention at 3 months.	A Biodex will be used to assess leg muscle power and strength.

Secondary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life Survey	From baseline to the end of the intervention at 3 months.	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.
Pittsburgh Sleep Quality Index	From baseline to the end of the intervention at 3 months.	This questionnaire assesses sleep quality. The PSQI is scored on a scale from 0-21 with a higher score indicating higher sleep quality.
Handgrip strength	From baseline to the end of the intervention at 3 months.	A hand-held dynamometer will be used to measure handgrip strength.
Dual Energy X-ray Absorptiometry (DXA)	From baseline to the end of the intervention at 3 months.	A DXA scan will be used to assess body composition and bone mineral density.
Waist circumference	From baseline to the end of the intervention at 3 months.	Waist circumference will be measured at the superior border of the iliac crest.
Hip circumference	From baseline to the end of the intervention at 3 months.	Hip circumference will be measured at the maximal protrusion of the buttocks.
Systolic blood pressure	From baseline to the end of the intervention at 3 months.	Systolic blood pressure will be measured at rest.
Diastolic blood pressure	From baseline to the end of the intervention at 3 months.	Diastolic blood pressure will be measured at rest.
Digit Symbol Substitution Test (DSST)	From baseline to the end of the intervention at 3 months.	The DSST assesses cognition and cognitive impairment.
Montreal Cognitive Assessment (MoCA)	From baseline to the end of the intervention at 3 months.	The MoCA assesses cognition and cognitive impairment. The MoCA is scored out of 30 points and a higher score indicates better cognitive function.
Short Physical Performance Battery	From baseline to the end of the intervention at 3 months.	A performance test to assess balance and physical function.
Low Density Lipoprotein Cholesterol	From baseline to the end of the intervention at 3 months.	A test assessing calculated LDL cholesterol.
Hemoglobin A1C Concentration	From baseline to the end of the intervention at 3 months.	This will assess a participants HbA1C.
Insulin Concentration	From baseline to the end of the intervention at 3 months.	This test will assess a participants fasting insulin.
Geriatric Depression Scale (GDS)	From baseline to the end of the intervention at 3 months.	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.
Generalized Anxiety Disorder (GAD)-7	From baseline to the end of the intervention at 3 months.	This survey assess feelings of anxiety. The GAD-7 is scored from 0-21, with higher scores indicating higher feelings of anxiety.
Perceived Stress Scale	From baseline to the end of the intervention at 3 months.	This survey assesses perceived stress. This survey is scored from 0-40 with higher scores indicating higher stress.
High Density Lipoprotein Cholesterol	From baseline to the end of the intervention at 3 months.	A blood test measuring HDL cholesterol.
Brief Resilience Scale	From baseline to the end of the intervention at 3 months.	This survey assess a participants resilience. This survey is scored from 0-30 with higher scores indicating a higher level of resilience.
Non-High Density Lipoprotein Cholesterol	From baseline to the end of the intervention at 3 months.	A blood test measuring non-HDL cholesterol.
Very Low Density Lipoprotein Cholesterol	From baseline to the end of the intervention at 3 months.	A blood test measuring VLDL cholesterol.
CD3 T cells	From baseline to the end of the intervention at 3 months.	This test will measure how many CD3 Mature T Cells are in the blood. This will be reported as a percentage.
CD4 T cells	From baseline to the end of the intervention at 3 months.	This test will measure the CD4 T cells in the blood. This will be reported as a percentage.
CD8 T cells	From baseline to the end of the intervention at 3 months.	This test will measure the CD8 T cells in the blood. This will be reported as a percentage.
Natural Killer cells	From baseline to the end of the intervention at 3 months.	This test will measure the NK cells in the blood. This will be reported as a percentage.
B cells	From baseline to the end of the intervention at 3 months.	This test will measure the B cells in the blood. This will be reported as a percentage.

Trial Locations

Locations (1)

Wexford Innovation Center; 🇺🇸 Phoenix, Arizona, United States