Clinical trial NCT04922710: Physical Exercise for Augmenting Cognitive Health (PEACH)
Official title: Physical Exercise for Augmenting Cognitive Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cognitive Aging
Adverse Childhood Experiences
Keywords: Adverse Childhood Experiences
Brain Health
Cognitive Aging
Exercise
Reversibility Network
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2021-06-11
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group assigned a remote exercise intervention
Primary purpose: TREATMENT

Brief summary: PEACH is a pilot project which is being conducted to determine the feasibility and acceptability of a 12-week home-based exercise intervention among Black and African American adults. A secondary aim of the project is to determine whether the exercise intervention improves cognitive and psychological functioning.

Detailed description: This pilot project aims to address the impact of early life adversity (ELA) on brain health in adulthood by conducting a pilot 12-week physical activity (PA) intervention delivered remotely using aerobic exercise bikes programmed to connect users with a trainer via an app. Investigators will recruit Black and African American individuals between the ages of 30-55 years (N = 40) who are currently sedentary and report experiencing at least one form of ELA prior to the age of 10. This study will be conducted at two sites: the University of Pittsburgh in Pittsburgh, PA, USA and the University of the West Indies in Kingston, Jamaica (site investigator: Terrence Forrester). At baseline and following the 12-week intervention, Investigators will collect a harmonized battery of cognitive, behavioral and psychosocial measures. The intervention itself will be home-based and will involve three 60-minute sessions of aerobic exercise per week using a Bluetooth-enable exercise bike. Participants' exercise programs will be supervised remotely by an exercise trainer and individualized depending on their age-adjusted heart rate reserve, with the goal being to have participants reach 50 minutes of moderate to vigorous intensity exercise per session by the end of the first 4 weeks of the intervention. The bikes will be outfitted with a tablet featuring an application called Neotiv. The Neotiv application will collect data from the bike regarding timing, duration, and intensity of exercise sessions, which will be securely shared with the exercise trainer to monitor attendance and adherence. The primary goals of this study are to determine whether the home-based exercise program (1) is feasible and acceptable (as measured by adherence and attendance), and (2) promotes improvements in cognitive and psychological functioning among adults who have been exposed to ELA, contingent on the feasibility. We realized that placing the health-related outcomes as primary or secondary outcomes would only make sense if the approach was feasible. Therefore, we revised the primary and secondary outcome measures to reflect the feasibility of the home-based exercise intervention program in terms of adherence and attendance.

Eligibility criteria: Inclusion Criteria:

1. adults aged 30-55 years
2. exposure to at least one form of threat-related adversity (e.g., exposure to violence; physical abuse) occurring prior to age 10 as documented by retrospective self-report
3. Self-identified Black or African American Race
4. access to high-speed internet
5. sedentary lifestyle (\<60 minutes of PA/week).
6. no difficulties with mobility
7. Does not currently require the use of an assisted walking device
8. Does not have a history of balance difficulties
9. Not currently pregnant or planning to become pregnant in the next 12 months

Exclusion Criteria:

1. Psychosis
2. Significant suicide risk (i.e., current, active suicidal ideation with a plan)
3. Engaging in moderate-intensity exercise \>=20 min per day, \>=3 times per week
4. Current treatment for cancer
5. Neurological condition (MS, Parkinson's, Dementia, MCI) or brain injury (Stroke)
6. Substance use disorder in the past 3-months
7. Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis (DVT) or other cardiovascular event
8. Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year
9. Sensory Impairment that would preclude neuropsychological testing
10. Not fluent in English
11. Travelling consecutively for 2+ weeks during the study
12. uncontrolled hypertension
13. Insulin-Dependent Diabetes Mellitus
14. Self-identified race anything other than Black or African American
15. Currently pregnant or planning to become pregnant in the next 12 months

Primary outcomes:
measure: Adherence to Exercise Intervention Program: Average Minutes Spent in Moderate to Vigorous Exercise
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Adherence to Exercise Intervention Program: Number of Sessions Completed
timeFrame: baseline to 12 weeks
Other outcomes:
measure: Mean Change in Systolic Blood Pressure
timeFrame: baseline to 12 weeks
measure: Mean Change in Physical Activity
timeFrame: baseline to 12 weeks
measure: Mean Change in Heart Rate
timeFrame: baseline to 12 weeks
measure: Percent Change in Total Body Weight
timeFrame: baseline to 12 weeks
measure: Mean Change in Negative and Positive Affect
timeFrame: baseline to 12 weeks
measure: Mean Change in Depressive Symptoms
timeFrame: baseline to 12 weeks
measure: Mean Change in Perceived Stress
timeFrame: baseline to 12 weeks
measure: Mean Change in Picture Sequence Performance
timeFrame: baseline to 12 weeks
measure: Mean Change in Picture Vocabulary Performance
timeFrame: baseline to 12 weeks
measure: Mean Change in Pattern Comparison Performance
timeFrame: baseline to 12 weeks
measure: Adherence to Exercise Intervention Program: Average Duration of Sessions
timeFrame: baseline to 12 weeks
measure: Mean Change in Flanker Performance
timeFrame: baseline to 12 weeks
measure: Mean Change in Dimensional Card Sort Performance
timeFrame: baseline to 12 weeks
measure: Mean Change in List Sorting Performance
timeFrame: baseline to 12 weeks
Locations:
city: Pittsburgh
country: United States
facility: Sennott Square
state: Pennsylvania
city: Kingston
country: Jamaica
facility: University of the West Indies
Study officials:
affiliation: University of Pittsburgh
name: Kirk I Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References: