Gerofit and Cognition

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT06107842

Collaborator

(none)

150

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aging Cognitive Impairment Physical Activity	Behavioral: Gerofit exercise Behavioral: Health education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlled studyrandomized controlled study

Masking:

Single (Outcomes Assessor)

Masking Description:

Gerofit intervention vs Health Education Control

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

Sep 30, 2027

Anticipated Study Completion Date :

Mar 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gerofit exercise Participants enrolled in the Gerofit program	Behavioral: Gerofit exercise Individualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week
Placebo Comparator: Health education Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session	Behavioral: Health education Scheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session

Arm

Intervention/Treatment

Active Comparator: Gerofit exercise

Participants enrolled in the Gerofit program

Behavioral: Gerofit exercise

Individualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week

Placebo Comparator: Health education

Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session

Behavioral: Health education

Scheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073-1003
2	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: Cathy C Lee, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Principal Investigator: Jonathan M Wanagat, MD PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Principal Investigator: Stacy Wilkins, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT06107842

Other Study ID Numbers:

E4521-R

First Posted:

Oct 30, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Oct 30, 2023