Cognitive AgingEarly Phase 1PEACHNCT04922710
Physical Exercise for Augmenting Cognitive Health (PEACH)
A Early Phase 1 study testing Home-based aerobic exercise in people with Cognitive Aging and Adverse Childhood Experiences, run by University of Pittsburgh at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Aging, Adverse Childhood Experiences
- What is being tested?
- Home-based aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Jan 2022to 30 May 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults aged 30-55 years
- 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
- Self-identified Black or African American Race
- access to high-speed internet
- sedentary lifestyle (<60 minutes of PA/week).
- no difficulties with mobility
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- Does not currently require the use of an assisted walking device
- Does not have a history of balance difficulties
- Not currently pregnant or planning to become pregnant in the next 12 months
Who cannot join
- Psychosis
- Significant suicide risk (i.e., current, active suicidal ideation with a plan)
- Engaging in moderate-intensity exercise >=20 min per day, >=3 times per week
- Current treatment for cancer
- Neurological condition (MS, Parkinson's, Dementia, MCI) or brain injury (Stroke)
- Substance use disorder in the past 3-months
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- Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis (DVT) or other cardiovascular event
- Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year
- Sensory Impairment that would preclude neuropsychological testing
- Not fluent in English
- Travelling consecutively for 2+ weeks during the study
- uncontrolled hypertension
- Insulin-Dependent Diabetes Mellitus
- Self-identified race anything other than Black or African American
- Currently pregnant or planning to become pregnant in the next 12 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Physical Exercise for Augmenting Cognitive Health
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.
Read the 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.
- Conditions
- Cognitive Aging, Adverse Childhood Experiences
- Being tested
- Home-based aerobic exercise
- Keywords
- Adverse Childhood Experiences, Brain Health, Cognitive Aging, Exercise, Reversibility Network
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based aerobic exerciseBehavioural
Guidelines for exercise programming (ACSM, 2018) will be followed including a warmup and cool down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity related injury. The exercise group will receive moderate to vigorous intensity aerobic exercise for 60 minutes per day, three times a week, for 12 weeks. Participants who are unable to do a 60-minute session would instead complete it in two 30-minute sessions. The prescribed intensity will be based on estimated heart rate reserve, calculated using resting heart rate and age-adjusted heart rate maximum (220-age in years). Participants will maintain a minimum heart rate from their specific calculation that will be monitored by Polar Heart Rate straps.
| Study group | Role | What they receive |
|---|---|---|
| Home-based aerobic exercise | Experimental | Un-supervised exercise will be held 3 times a week for 60 minutes in the participant's home. Those who are unable to do a 60-minute session would instead complete it in two 30-minute sessions to reach the goal of exercising 150 minutes per week. Receives: Behavioral: Home-based aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Exercise Intervention Program: Average Minutes Spent in Moderate to Vigorous Exercise
Data regarding the average number of minutes spent engaging in moderate to vigorous exercise (via heart rate monitoring and comparison of heart rate to calculations based on heart rate reserve) will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability.
Measured: baseline to 12 weeks
Secondary outcomes (1)
Adherence to Exercise Intervention Program: Number of Sessions Completed
Data regarding the number of exercise sessions completed will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start4 Jan 2022
- Primary completion3 May 2023
- Study completion30 May 2023
Why it stopped: The study protocol was not feasible. We made several modifications but halted the study prematurely before we met our target sample size goal.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive AgingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group assigned a remote exercise intervention
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kirk Erickson, PhD, University of Pittsburgh
- Investigators
- Kirk I Erickson, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922710
- Sponsor's protocol ID
- STUDY20120192
- Other IDs
- R24AG065174-01
- Acronym
- PEACH
- Status last verified
- May 2024
- First submitted
- 8 Jun 2021
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from this study will be made available to outside investigators under a data-sharing agreement. The data will be available to outside investigators after publication of the primary aims and at completion of quality control assessments and data organization. The investigators expect that the data from this study will result in interest from internal and external investigators for secondary analysis and ancillary projects.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise for Augmenting Cognitive Health
- ClinicalTrials.gov ID
- NCT04922710
- Acronym / sponsor ID
- PEACH / STUDY20120192
- Conditions
- Cognitive Aging, Adverse Childhood Experiences
- Keywords
- Adverse Childhood Experiences, Brain Health, Cognitive Aging, Exercise, Reversibility Network
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study protocol was not feasible. We made several modifications but halted the study prematurely before we met our target sample size goal.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group assigned a remote exercise intervention
| Arm | Type | Receives |
|---|---|---|
| Home-based aerobic exercise | Experimental | Behavioral: Home-based aerobic exerciseUn-supervised exercise will be held 3 times a week for 60 minutes in the participant's home. Those who are unable to do a 60-minute session would instead complete it in two 30-minute sessions to reach the goal of exercising 150 minutes per week. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- adults aged 30-55 years
- 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
- Self-identified Black or African American Race
- access to high-speed internet
- sedentary lifestyle (<60 minutes of PA/week).
Key exclusion criteria (15 listed)
- Psychosis
- Significant suicide risk (i.e., current, active suicidal ideation with a plan)
- Engaging in moderate-intensity exercise >=20 min per day, >=3 times per week
- Current treatment for cancer
- Neurological condition (MS, Parkinson's, Dementia, MCI) or brain injury (Stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based aerobic exerciseGuidelines for exercise programming (ACSM, 2018) will be followed including a warmup and cool down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity related injury. The exercise group will receive moderate to vigorous intensity aerobic exercise for 60 minutes per day, three times a week, for 12 weeks. Participants who are unable to do a 60-minute session would instead complete it in two 30-minute sessions. The prescribed intensity will be based on estimated heart rate reserve, calculated using resting heart rate and age-adjusted heart rate maximum (220-age in years). Participants will maintain a minimum heart rate from their specific calculation that will be monitored by Polar Heart Rate straps. | Behavioural | Home-based aerobic exercise |
Primary outcome
Adherence to Exercise Intervention Program: Average Minutes Spent in Moderate to Vigorous Exercise
Time frame: baseline to 12 weeks
Data regarding the average number of minutes spent engaging in moderate to vigorous exercise (via heart rate monitoring and comparison of heart rate to calculations based on heart rate reserve) will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability.
1 secondary outcome
Adherence to Exercise Intervention Program: Number of Sessions Completed
Time frame: baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data from this study will be made available to outside investigators under a data-sharing agreement. The data will be available to outside investigators after publication of the primary aims and at completion of quality control assessments and data organization. The investigators expect that the data from this study will result in interest from internal and external investigators for secondary analysis and ancillary projects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk I Erickson, PhD principal investigator
University of Pittsburgh
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Home-based aerobic exercise in people with Cognitive Aging and Adverse Childhood Experiences, run by University of Pittsburgh at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Exercise Intervention Program: Average Minutes Spent in Moderate to Vigorous Exercise (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.