Mild Cognitive ImpairmentNCT05370118
Improving Physical Activity With Cognitive Impairment
A study testing Telerehabilitation physical activity behavioral (TPAB) intervention in people with Mild Cognitive Impairment and Caregiver Burnout, run by Creighton University at 1 site in United States.
Trial summary
Individuals with mild cognitive impairment are often physically inactive and at risk for progressing to dementia. Physical inactivity is considered a modifiable risk factor for dementia. Therefore, interventions must be developed to foster sustainable improvement in daily physical activity. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Caregiver Burnout
- What is being tested?
- Telerehabilitation physical activity behavioral (TPAB) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 30 Jun 2025
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-85 years old (patient); 19+ years (caregiver)
- clinically diagnosed with amnestic MCI (patient only)
- a score of 18-24 on the Montreal Cognitive Assessment indicating possible MCI (patient only),
- not currently categorized as "Active" on the Rapid Assessment of Physical Activity, (patient only)
- on stable doses of medication at least for the previous 30 days at baseline (patient only)
- have a computer/wireless device with Internet access
- have a primary caregiver willing to participate in physical activity and assist the patient with participation in the study
- English-speaking
Who cannot join
- limitations due to disability, illness, or pain that may affect the patient's walking safety during the study
- unstable heart conditions (e.g., unstable angina, acute pericarditis)
- uncontrolled hypertension in the last six months
- known neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Individuals with mild cognitive impairment are often physically inactive and at risk for progressing to dementia. Physical inactivity is considered a modifiable risk factor for dementia. Therefore, interventions must be developed to foster sustainable improvement in daily physical activity. To address this problem, our pilot study aims are directed at assessing the feasibility and preliminary improvement of physical activity following the use of a mobile-health technology physical activity behavior change intervention. Similar interventions have shown to be very effective in older adults without cognitive impairment. We specifically focus on the subtype of amnestic mild cognitive impairment since this subtype often progresses to Alzheimer's Disease, a leading cause of death in the US. Improving physical activity is one approach to reduce the progression to Alzheimer's Disease and subsequently lower mortality. To increase the impact of the intervention, participants with amnestic mild cognitive impairment will be recruited along with a primary caregiver (dyads). Thirty dyads will be recruited and randomized to either an intervention group (15 dyads) or usual care group (15 dyads). The intervention group will receive a 12-week mobile-health technology physical activity behavior change intervention structured to improve physical activity. The intervention is unique in the combination of established behavior change theories and techniques and remote delivery for individuals with amnestic mild cognitive impairment. This pilot study is designed to assess the feasibility of the intervention by examining participant and primary caregiver retention, intervention session attendance, intervention acceptability and safety, and qualitative perspectives. Secondly, this pilot study will assess preliminary improvement in physical activity (i.e., daily steps). Improvement will be determined based on significant changes in participants' daily steps observed via accelerometry post-intervention in the intervention group compared to the usual care control group. The results of this study will support future work (K-award and R01 submissions) to explore efficacy and larger-scale implementation to reach rural and underserved areas of Nebraska and beyond.
Read the detailed description
The primary objective of this pilot study is to determine the feasibility and preliminary efficacy of a telerehabilitation physical activity behavioral (TPAB) intervention for improving habitual physical activity in individuals with amnestic mild cognitive impairment (MCI).
Amnestic MCI is considered a precursor to Alzheimer's Disease (AD), the sixth leading cause of death in the US.1 Additionally, loss of independence and cognitive function is one of the most feared aspects of aging for older adults.2,3 One way to promote independence is through physical activity. Physical inactivity is highly reported in those with MCI4 and is a modifiable risk factor for those with dementia.5,6 Therefore, strategies to combat the loss of physical independence and cognition are of high economic and quality of life priority.
Home-based physical activity behavior change methods have successfully improved physical activity in healthy older adults7-10 but have had limited use in individuals with MCI.11 This study will determine the feasibility and preliminary efficacy of the TPAB intervention in individuals with amnestic MCI and caregivers to provide the groundwork to ascertain clinical implementation. In this randomized controlled clinical research study, we will assess the feasibility and preliminary efficacy of the TPAB intervention in individuals with amnestic MCI. The TPAB intervention consists of 12 telerehabilitation sessions (30 min) over 12 weeks. Primary caregivers will be included during all intervention sessions based on dyadic approaches demonstrating higher physical activity invention success in individuals with MCI compared to individual recruitment.12 The TPAB intervention group will include 15 dyads of patients with amnestic MCI and their primary caregivers. The TPAB intervention is an evidence-based intervention designed to improve daily steps in older adults with medical complexities.13-15 It combines strategies such as problem-solving11, action planning16, and motivational interviewing17 that are evidenced to improve physical activity in individuals with MCI.11,16,17 The TPAB intervention will require a wearable sensor (Fitbit) and a home-based tablet/laptop to allow real-time activity feedback and video interface between participants and the interventionist. The TPAB intervention is novel in combining theories and techniques and remote delivery for individuals with amnestic MCI. The control (CTL) group will include 15 dyads of individuals with amnestic MCI and their primary caregivers that will receive usual care over the 12 weeks. Outcomes for both groups will be assessed before the intervention (baseline) and at the end of the intervention (POST). The specific aims are:
Aim 1: Determine the feasibility of the TPAB intervention for individuals with amnestic MCI and their primary caregivers by measuring 1) participant retention, 2) attendance, 3) acceptability (Intrinsic Motivation Inventory18), 3) safety (adverse event tracking), 4) semi-structured interviews.
Aim 2: Examine the preliminary effects of TPAB on physical activity engagement among MCI participants when compared with the CTL group.
Hypothesis 2.1: Individuals with amnestic MCI will make significant (p<0.05) gains in accelerometer-assessed (activPAL) physical activity (daily steps) from baseline to POST compared to the CTL group.
Clinical Impact: This study addresses two significant clinical gaps for amnestic MCI rehabilitation: 1) lack of evidence-based rehabilitation strategies to improve habitual physical activity; and 2) barriers to remotely promote habitual physical activity. Lastly, this project will bring together an interdisciplinary team (physical therapist (RH), exercise scientist (DE), and neuropsychologist (VP)) of investigators at Creighton University and the University of Nebraska Medical Center (UNMC).
- Conditions
- Mild Cognitive Impairment, Caregiver Burnout
- Being tested
- Telerehabilitation physical activity behavioral (TPAB) intervention
- Keywords
- physical activity, behavior change
- Medical subject headings
- Cognitive Dysfunction, Caregiver Burden, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation physical activity behavioral (TPAB) interventionBehavioural
The intervention includes the behavior change techniques of self-monitoring of behavior, action planning, graded tasks, restructuring the physical and social environment, problem-solving, and prompts/cues.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation physical activity behavioral (TPAB) intervention | Experimental | Individuals in the TPAB intervention will participate in a weekly session for 12 weeks with their primary caregiver and the research interventionist (RH). Established behavior-change techniques will be used in the TPAB intervention, based largely on the combination of the Social Cognitive Theory, Control Theory, and Operant Conditioning,43 including behavioral techniques, and patient-centered communication (e.g., motivational interviewing).44 The behavior-change techniques are designed to target and improve daily steps. Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. Receives: Behavioral: Telerehabilitation physical activity behavioral (TPAB) intervention |
| Control Group | No intervention | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TPAB Intervention Participant Retention
The number of participants that complete the 12 week intervention will be calculated to determine participant retention.
Measured: The outcome will be reported at the end of the 12 week intervention.
TPAB Intervention Attendance
The number of weekly sessions attended across the intervention will be summed and divided by the total number of scheduled sessions (12 per person). This number will be converted to a percentage to determine the TPAB Intervention Attendance.
Measured: The outcome will be reported at the end of the 12 week intervention.
TPAB Intervention Acceptability
The acceptability of the TPAB Intervention will be assessed by administering the Intrinsic Motivation Inventory Interest/Enjoyment Subscale at the conclusion of the intervention. The Intrinsic Motivation Inventory Subscale includes 7 statements that require the participant to respond on a 1-7 scale to the level they agree with the statement. The responses to the questions are then summed and averaged to generate an Interest/Enjoyment score (1-7) with higher scores indicating greater Interest/Enjoyment.
Measured: The outcome will be reported at the end of the 12 week intervention.
TPAB Intervention Safety
The safety of the TPAB Intervention will be assessed by tracking and comparing the number of adverse events in the intervention and control group.
Measured: The outcome will be reported at the end of the 12 week intervention.
Feasibility of the TPAB Intervention (Semi-Structured Interviews)
Semi-structured interview will be conducted on the patient and caregivers that participated in the TPAB Intervention. Directed content analysis was used to assess the qualitative data gathered from semi-structured interviews.
Measured: Semi-Structured Interviews will be conducted at the end of the 12 week intervention.
Secondary outcomes (1)
Change in Average Daily Steps
Daily step count will be measured with the activPAL physical activity monitor and assessed over a seven day period at baseline and the end of week 12. The total number of steps over each seven day period will be averaged to get the participants average daily step count at baseline and post-intervention. Averages across the seven days will be recorded and used to calculate the change in average daily step count from baseline to post-intervention reported.
Measured: The outcome will be reported at the end of the 12 week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Feb 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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 Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- This pilot clinical research study is structured as a feasibility and preliminary efficacy trial to determine if the TPAB intervention is feasible and to compare daily step improvement between the TPAB intervention group and the CTL group. The trial is designed to inform a future larger-scale efficacy trial to assess longer time points for the sustainability of intervention impact.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370118
- Sponsor's protocol ID
- 2002895
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2022
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data will be available upon request. Other data sharing is undecided at this time.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Activity With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05370118
- Acronym / sponsor ID
- 2002895
- Conditions
- Mild Cognitive Impairment, Caregiver Burnout
- Keywords
- physical activity, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with mild cognitive impairment are often physically inactive and at risk for progressing to dementia. Physical inactivity is considered a modifiable risk factor for dementia. Therefore, interventions must be developed to foster sustainable improvement in daily physical activity. To address this problem, our pilot study aims are directed at assessing the feasibility and preliminary improvement of physical activity following the use of a mobile-health technology physical activity behavior change intervention. Similar interventions have shown to be very effective in older adults without cognitive impairment. We specifically focus on the subtype of amnestic mild cognitive impairment since this subtype often progresses to Alzheimer's Disease, a leading cause of death in the US. Improving physical activity is one approach to reduce the progression to Alzheimer's Disease and subsequently lower mortality. To increase the impact of the intervention, participants with amnestic mild cognitive impairment will be recruited along with a primary caregiver (dyads). Thirty dyads will be recruited and randomized to either an intervention group (15 dyads) or usual care group (15 dyads). The intervention group will receive a 12-week mobile-health technology physical activity behavior change intervention structured to improve physical activity. The intervention is unique in the combination of established behavior change theories and techniques and remote delivery for individuals with amnestic mild cognitive impairment. This pilot study is designed to assess the feasibility of the intervention by examining participant and primary caregiver retention, intervention session attendance, intervention acceptability and safety, and qualitative perspectives. Secondly, this pilot study will assess preliminary improvement in physical activity (i.e., daily steps). Improvement will be determined based on significant changes in participants' daily steps observed via accelerometry post-intervention in the intervention group compared to the usual care control group. The results of this study will support future work (K-award and R01 submissions) to explore efficacy and larger-scale implementation to reach rural and underserved areas of Nebraska and beyond.
Detailed description
The primary objective of this pilot study is to determine the feasibility and preliminary efficacy of a telerehabilitation physical activity behavioral (TPAB) intervention for improving habitual physical activity in individuals with amnestic mild cognitive impairment (MCI).
Amnestic MCI is considered a precursor to Alzheimer's Disease (AD), the sixth leading cause of death in the US.1 Additionally, loss of independence and cognitive function is one of the most feared aspects of aging for older adults.2,3 One way to promote independence is through physical activity. Physical inactivity is highly reported in those with MCI4 and is a modifiable risk factor for those with dementia.5,6 Therefore, strategies to combat the loss of physical independence and cognition are of high economic and quality of life priority.
Home-based physical activity behavior change methods have successfully improved physical activity in healthy older adults7-10 but have had limited use in individuals with MCI.11 This study will determine the feasibility and preliminary efficacy of the TPAB intervention in individuals with amnestic MCI and caregivers to provide the groundwork to ascertain clinical implementation. In this randomized controlled clinical research study, we will assess the feasibility and preliminary efficacy of the TPAB intervention in individuals with amnestic MCI. The TPAB intervention consists of 12 telerehabilitation sessions (30 min) over 12 weeks. Primary caregivers will be included during all intervention sessions based on dyadic approaches demonstrating higher physical activity invention success in individuals with MCI compared to individual recruitment.12 The TPAB intervention group will include 15 dyads of patients with amnestic MCI and their primary caregivers. The TPAB intervention is an evidence-based intervention designed to improve daily steps in older adults with medical complexities.13-15 It combines strategies such as problem-solving11, action planning16, and motivational interviewing17 that are evidenced to improve physical activity in individuals with MCI.11,16,17 The TPAB intervention will require a wearable sensor (Fitbit) and a home-based tablet/laptop to allow real-time activity feedback and video interface between participants and the interventionist. The TPAB intervention is novel in combining theories and techniques and remote delivery for individuals with amnestic MCI. The control (CTL) group will include 15 dyads of individuals with amnestic MCI and their primary caregivers that will receive usual care over the 12 weeks. Outcomes for both groups will be assessed before the intervention (baseline) and at the end of the intervention (POST). The specific aims are:
Aim 1: Determine the feasibility of the TPAB intervention for individuals with amnestic MCI and their primary caregivers by measuring 1) participant retention, 2) attendance, 3) acceptability (Intrinsic Motivation Inventory18), 3) safety (adverse event tracking), 4) semi-structured interviews.
Aim 2: Examine the preliminary effects of TPAB on physical activity engagement among MCI participants when compared with the CTL group.
Hypothesis 2.1: Individuals with amnestic MCI will make significant (p<0.05) gains in accelerometer-assessed (activPAL) physical activity (daily steps) from baseline to POST compared to the CTL group.
Clinical Impact: This study addresses two significant clinical gaps for amnestic MCI rehabilitation: 1) lack of evidence-based rehabilitation strategies to improve habitual physical activity; and 2) barriers to remotely promote habitual physical activity. Lastly, this project will bring together an interdisciplinary team (physical therapist (RH), exercise scientist (DE), and neuropsychologist (VP)) of investigators at Creighton University and the University of Nebraska Medical Center (UNMC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This pilot clinical research study is structured as a feasibility and preliminary efficacy trial to determine if the TPAB intervention is feasible and to compare daily step improvement between the TPAB intervention group and the CTL group. The trial is designed to inform a future larger-scale efficacy trial to assess longer time points for the sustainability of intervention impact.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation physical activity behavioral (TPAB) intervention | Experimental | Behavioral: Telerehabilitation physical activity behavioral (TPAB) interventionIndividuals in the TPAB intervention will participate in a weekly session for 12 weeks with their primary caregiver and the research interventionist (RH). Established behavior-change techniques will be used in the TPAB intervention, based largely on the combination of the Social Cognitive Theory, Control Theory, and Operant Conditioning,43 including behavioral techniques, and patient-centered communication (e.g., motivational interviewing).44 The behavior-change techniques are designed to target and improve daily steps. Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
| Control Group | No intervention | –Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 50-85 years old (patient); 19+ years (caregiver)
- clinically diagnosed with amnestic MCI (patient only)
- a score of 18-24 on the Montreal Cognitive Assessment indicating possible MCI (patient only),
- not currently categorized as "Active" on the Rapid Assessment of Physical Activity, (patient only)
- on stable doses of medication at least for the previous 30 days at baseline (patient only)
Key exclusion criteria (4 listed)
- limitations due to disability, illness, or pain that may affect the patient's walking safety during the study
- unstable heart conditions (e.g., unstable angina, acute pericarditis)
- uncontrolled hypertension in the last six months
- known neurological diseases
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 |
|---|---|---|
| Telerehabilitation physical activity behavioral (TPAB) interventionThe intervention includes the behavior change techniques of self-monitoring of behavior, action planning, graded tasks, restructuring the physical and social environment, problem-solving, and prompts/cues. | Behavioural | Telerehabilitation physical activity behavioral (TPAB) intervention |
Primary outcome
TPAB Intervention Participant Retention
Time frame: The outcome will be reported at the end of the 12 week intervention.
The number of participants that complete the 12 week intervention will be calculated to determine participant retention.
TPAB Intervention Attendance
Time frame: The outcome will be reported at the end of the 12 week intervention.
The number of weekly sessions attended across the intervention will be summed and divided by the total number of scheduled sessions (12 per person). This number will be converted to a percentage to determine the TPAB Intervention Attendance.
TPAB Intervention Acceptability
Time frame: The outcome will be reported at the end of the 12 week intervention.
The acceptability of the TPAB Intervention will be assessed by administering the Intrinsic Motivation Inventory Interest/Enjoyment Subscale at the conclusion of the intervention. The Intrinsic Motivation Inventory Subscale includes 7 statements that require the participant to respond on a 1-7 scale to the level they agree with the statement. The responses to the questions are then summed and averaged to generate an Interest/Enjoyment score (1-7) with higher scores indicating greater Interest/Enjoyment.
TPAB Intervention Safety
Time frame: The outcome will be reported at the end of the 12 week intervention.
The safety of the TPAB Intervention will be assessed by tracking and comparing the number of adverse events in the intervention and control group.
Feasibility of the TPAB Intervention (Semi-Structured Interviews)
Time frame: Semi-Structured Interviews will be conducted at the end of the 12 week intervention.
Semi-structured interview will be conducted on the patient and caregivers that participated in the TPAB Intervention. Directed content analysis was used to assess the qualitative data gathered from semi-structured interviews.
1 secondary outcome
Change in Average Daily Steps
Time frame: The outcome will be reported at the end of the 12 week intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Individual Participant Data will be available upon request. Other data sharing is undecided at this time.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation physical activity behavioral (TPAB) intervention in people with Mild Cognitive Impairment and Caregiver Burnout, run by Creighton University 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 14 May 2026. 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 14 May 2026). 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?
TPAB Intervention Participant Retention (time frame: The outcome will be reported at the end of the 12 week intervention.). The study lists 5 primary outcomes in all. 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 14 May 2026.