Physical ActivityNCT03058146
Independent Walking for Brain Health
A study testing Mobile Health Walking Condition and Healthy Aging Education Condition in people with Physical Activity and Aging, run by University of California, San Diego at 1 site in United States.
Trial summary
Physical activity interventions with older adults can improve brain health; however most interventions have been performed in gym-like settings that reach a small sector of the senior population. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Aging
- What is being tested?
- Mobile Health Walking Condition and Healthy Aging Education Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 20 May 2020
- Phase
- Interventional
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women between the ages of 65-80
- Ability to obtain a signed physician's clearance for participation in this study
- English-speaking as needed to complete cognitive testing and follow study procedures
- Cognitively normal (based on comprehensive neuropsychological assessment)
- No contraindications for Magnetic Resonance Imaging (MRI)
- Must be ambulatory and able to walk independently
Who cannot join
- History of head injury involving loss of consciousness within the past 6 months and/or history of severe traumatic brain injury
- Major neurological disorders (dementia, multiple sclerosis, epilepsy, etc)
- Chronic major psychiatric disorders (schizophrenia, major recurrent affective disorder)
- History of major vascular events (myocardial infarction, stroke, etc),
- History of diabetes
- History of falls in the last year resulting in hospitalization
- Unstable or poorly controlled medical problems e.g. heart failure, diabetes (poorly controlled or on insulin), uncontrolled hypertension, pulmonary disease with hypoxia or hypercapnia, significant liver problems or renal failure, treatment of cancer in the past 2 years (other than non-melanoma skin cancer), HIV positive
- Objective evidence of cognitive impairment based on neuropsychological assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition
Physical activity interventions with older adults can improve brain health; however most interventions have been performed in gym-like settings that reach a small sector of the senior population. Since not everyone can access a gym, it is important to study whether brisk walking in real world environments can also help brain health. This study will use mobile health devices to help older adults independently walk for brain health, thus representing a critical step towards the dissemination of physical activity intervention programs aimed at preserving cognitive function in aging.
Read the detailed description
Physical activity interventions conducted in supervised settings (laboratories and group settings) with older adults have consistently shown improved cardiovascular and cerebrovascular health and improved cognitive function. What is lacking is the development of interventions that take place in real world environments and that take advantage of new technologies to help objectively track real time physical activity behaviors. Real world physical activity interventions have the potential to reach a larger segment of the population and to enhance maintenance after the intervention period ends. This study will develop a novel physical activity intervention using mobile health technologies to promote physical activity levels likely to affect cerebral blood flow and cognition in real world environments in cognitively normal older adults. A randomized controlled trial will be conducted with 30 participants being assigned to the mobile health physical activity condition (walking in free-living environments tracked via mobile health technologies) and another 30 to an education control condition (at home reading about healthy aging materials) for 3 months.
- Conditions
- Physical Activity, Aging
- Being tested
- Mobile Health Walking Condition, Healthy Aging Education Condition
- Keywords
- Exercise, Fitness, Physical Activity, Cognitive Aging, Cerebral Blood Flow, Brain Imaging, Unsupervised Intervention, Mobile Health, Free-living exercise intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Walking ConditionBehavioural
Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.
Healthy Aging Education ConditionBehavioural
The education control condition will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health Walking Condition | Experimental | Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week. Receives: Behavioral: Mobile Health Walking Condition |
| Healthy Aging Education Condition | Active comparator | The education control condition will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement. Receives: Behavioral: Healthy Aging Education Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate to Vigorous Physical Activity (MVPA) Average Per Day
Average minutes per day spent in moderate to vigorous levels of physical activity (MVPA) (defined as =>1952 accelerometer counts per minute). MVPA minutes were determined based on one-week of accelerometer wear on the hip at baseline and post intervention.
Measured: Pre (baseline) and post (3 months)
Secondary outcomes (1)
Cerebral Blood Flow (Hippocampal and Frontal)
Average cerebral blood flow measured with arterial spin labeling magnetic resonance imaging in ml/100g/min. Cerebral blood flow was obtained via arterial spin labeling MRI and Freesurfer software was utilized to delineate regions of interest for each participant (right and left regions were averaged). For the frontal lobe cerebral blood flow we averaged the mean of superior frontal, rostral and caudal middle frontal, pars opercularis, pars triangularis, pars orbitalis, lateral and medial orbitofrontal, precentral, paracentral, and frontal pole.
Measured: Pre (baseline) and post (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start12 Oct 2017
- Primary completion18 May 2020
- Study completion20 May 2020
Why it stopped: COVID-19 shut down of research operations
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with ongoing enrollment into each arm (individual intervention)
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Zvinka Z. Zlatar, University of California, San Diego
- Investigators
- Zvinka Z Zlatar, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058146
- Sponsor's protocol ID
- 20153238
- Other IDs
- K23AG049906
- Status last verified
- Jul 2023
- First submitted
- 10 Feb 2017
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate. Publication of data shall occur during and at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.
Publications
Hays Weeks CC, Moore AA, Allison M, Patrick K, Bondi MW, Nebeker C, Liu TT, Wing D, Higgins M, Hartman SJ, Rissman RA, Zlatar ZZ. The Independent Walking for Brain Health Intervention for Older Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e42980. doi: 10.2196/42980.
PubMed 36535765Nebeker C, Zlatar ZZ. Learning From Older Adults to Promote Independent Physical Activity Using Mobile Health (mHealth). Front Public Health. 2021 Aug 12;9:703910. doi: 10.3389/fpubh.2021.703910. eCollection 2021.
PubMed 34476229
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition
- ClinicalTrials.gov ID
- NCT03058146
- Acronym / sponsor ID
- 20153238
- Conditions
- Physical Activity, Aging
- Keywords
- Exercise, Fitness, Physical Activity, Cognitive Aging, Cerebral Blood Flow, Brain Imaging, Unsupervised Intervention, Mobile Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 shut down of research operations
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity interventions with older adults can improve brain health; however most interventions have been performed in gym-like settings that reach a small sector of the senior population. Since not everyone can access a gym, it is important to study whether brisk walking in real world environments can also help brain health. This study will use mobile health devices to help older adults independently walk for brain health, thus representing a critical step towards the dissemination of physical activity intervention programs aimed at preserving cognitive function in aging.
Detailed description
Physical activity interventions conducted in supervised settings (laboratories and group settings) with older adults have consistently shown improved cardiovascular and cerebrovascular health and improved cognitive function. What is lacking is the development of interventions that take place in real world environments and that take advantage of new technologies to help objectively track real time physical activity behaviors. Real world physical activity interventions have the potential to reach a larger segment of the population and to enhance maintenance after the intervention period ends. This study will develop a novel physical activity intervention using mobile health technologies to promote physical activity levels likely to affect cerebral blood flow and cognition in real world environments in cognitively normal older adults. A randomized controlled trial will be conducted with 30 participants being assigned to the mobile health physical activity condition (walking in free-living environments tracked via mobile health technologies) and another 30 to an education control condition (at home reading about healthy aging materials) for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with ongoing enrollment into each arm (individual intervention)
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Walking Condition | Experimental | Behavioral: Mobile Health Walking ConditionPhysically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week. |
| Healthy Aging Education Condition | Active comparator | Behavioral: Healthy Aging Education ConditionThe education control condition will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Men and women between the ages of 65-80
- Ability to obtain a signed physician's clearance for participation in this study
- English-speaking as needed to complete cognitive testing and follow study procedures
- Cognitively normal (based on comprehensive neuropsychological assessment)
- No contraindications for Magnetic Resonance Imaging (MRI)
Key exclusion criteria (8 listed)
- History of head injury involving loss of consciousness within the past 6 months and/or history of severe traumatic brain injury
- Major neurological disorders (dementia, multiple sclerosis, epilepsy, etc)
- Chronic major psychiatric disorders (schizophrenia, major recurrent affective disorder)
- History of major vascular events (myocardial infarction, stroke, etc),
- History of diabetes
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 |
|---|---|---|
| Mobile Health Walking ConditionPhysically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week. | Behavioural | Mobile Health Walking Condition |
| Healthy Aging Education ConditionThe education control condition will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement. | Behavioural | Healthy Aging Education Condition |
Primary outcome
Moderate to Vigorous Physical Activity (MVPA) Average Per Day
Time frame: Pre (baseline) and post (3 months)
Average minutes per day spent in moderate to vigorous levels of physical activity (MVPA) (defined as =>1952 accelerometer counts per minute). MVPA minutes were determined based on one-week of accelerometer wear on the hip at baseline and post intervention.
1 secondary outcome
Cerebral Blood Flow (Hippocampal and Frontal)
Time frame: Pre (baseline) and post (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36535765Hays Weeks CC, Moore AA, Allison M, Patrick K, Bondi MW, Nebeker C, Liu TT, Wing D, Higgins M, Hartman SJ, Rissman RA, Zlatar ZZ. The Independent Walking for Brain Health Intervention for Older Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e42980. doi: 10.2196/42980.
- Derived from this study: PubMed 34476229Nebeker C, Zlatar ZZ. Learning From Older Adults to Promote Independent Physical Activity Using Mobile Health (mHealth). Front Public Health. 2021 Aug 12;9:703910. doi: 10.3389/fpubh.2021.703910. eCollection 2021.
- Individual participant dataSharing planned: No. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate. Publication of data shall occur during and at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.
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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.
Zvinka Z Zlatar, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Walking Condition and Healthy Aging Education Condition in people with Physical Activity and Aging, run by University of California, San Diego at 1 site in United States.
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 6 inclusion and 8 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 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2023). 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?
Moderate to Vigorous Physical Activity (MVPA) Average Per Day (time frame: Pre (baseline) and post (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058146, which also lists 2 linked publications.
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 17 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.