Gerofit and Cognition

Aging Clinical Trial

Official title:

Relationship of Exercise Frequency, Intensity, and Fitness to Improved Cognition and Biomarkers in Gerofit Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107842
• Other study ID #: E4521-R
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Cathy C Lee, MD
• Phone: (310) 268-4110
• Email: cathy.lee2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia prevalence increases with age, and with the increase in the population of people ages 65 and older, the total number of people with dementia is also increasing. Older Veterans often have comorbid PTSD, major depression and traumatic brain injury so that they are at 2 to 5 times the risk for cognitive impairment and dementia compared to the general population. There is evidence that exercise interventions in sedentary older adults could improve both physical and cognitive function. However, there have been very few studies on the effects of exercise on cognition in older Veterans and do not reflect the broader ethnic and health-status diversity of Veterans. Thus, improved knowledge of the role of exercise on cognition as well as the predictive power of biomarkers could have a major beneficial impact on Veterans' functional independence and quality of life. The investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans and that blood and muscle biomarkers will predict these improvements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• All Veterans eligible for VA Gerofit program 65 years and older

• Clearance by PCP to participate in Gerofit exercise program

Exclusion Criteria:

• Inability to perform ADLs

• Significant cognitive impairment

• Inability to function independently without assistance

• Unstable angina; proliferative diabetic retinopathy

• Oxygen dependent

• Unwillingly to commute and/or not able to provide own transportation to Gerofit

• Incontinence

• Open wounds

• Volatile behavioral issue or unable to work successfully in a group environment/setting

• Active substance abuse

• Homelessness

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• Cognitive Impairment
• Physical Activity

Intervention

Behavioral:
• Gerofit exercise
Individualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week
• Health education
Scheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory composite score	HVLT-R, verbal memory and BVMT-R, visual memory	Change from baseline at 3 months
Primary	Executive Function composite score	Stroop C, Trails B, Digit span backwards and sequencing from WAIS-IV, verbal fluency, FAS and animals	Change from baseline at 3 months
Primary	Total BDNF	Total brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 3 months
Primary	Mature BDNF	Mature brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 3 months
Primary	Memory composite score	HVLT-R, verbal memory and BVMT-R, visual memory	Change from baseline at 12 months
Primary	Executive Function composite score	Stroop C, Trails B, Digit span backwards and sequencing from WAIS-IV, verbal fluency, FAS and animals	Change from baseline at 12 months
Primary	Total BDNF	Total brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 12 months
Primary	Mature BDNF	Mature brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 12 months