Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation physical activity behavioral (TPAB) intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TPAB Intervention Participant Retention | The number of participants that complete the 12 week intervention will be calculated to determine participant retention. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University | Omaha | Nebraska | 68178 | United States |
Individual Participant Data will be available upon request. Other data sharing is undecided at this time.
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was done via a Mind Brain Health Registry and distribution of flyers at clinics and on social media. Participants on the registry were contacted by the research team or voluntarily identified themselves as interested using the contact information on the flyer.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telerehabilitation Physical Activity Behavioral (TPAB) Intervention - Patient | 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, including behavioral techniques, and patient-centered communication (e.g., motivational interviewing). The behavior-change techniques are designed to target and improve daily steps. |
| FG001 | Telerehabilitation Physical Activity Behavioral (TPAB) Intervention - Care Partner | 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, including behavioral techniques, and patient-centered communication (e.g., motivational interviewing). The behavior-change techniques are designed to target and improve daily steps. |
| FG002 | Control (CTL) Group - Patient | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
| FG003 | Control (CTL) Group - Care Partner | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telerehabilitation Physical Activity Behavioral (TPAB) Intervention - Patient | 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, including behavioral techniques, and patient-centered communication (e.g., motivational interviewing). The behavior-change techniques are designed to target and improve daily steps. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TPAB Intervention Participant Retention | The number of participants that complete the 12 week intervention will be calculated to determine participant retention. | Posted | Count of Participants | Participants | The outcome will be reported at the end of the 12 week intervention. |
|
From enrollment until end of post-testing (14 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telerehabilitation Physical Activity Behavioral (TPAB) Intervention - Patient | 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, including behavioral techniques, and patient-centered communication (e.g., motivational interviewing). The behavior-change techniques are designed to target and improve daily steps. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Collapsed Lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Participant suffered a collapsed lung. Cause unknown, but was unrelated to receiving the intervention. Resulted in a 5-day inpatient hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Participant fell walking down stairs in garage. Experienced minor bruising and scratches. |
Sample size limitation. Did not reach number of participants for our targeted power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rashelle Hoffman | Creighton University - Department of Physical Therapy | 402-280-5691 | RashelleHoffman@creighton.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2025 | Feb 23, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000084802 | Caregiver Burden |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
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.
Not provided
Not provided
The outcomes assessors will be masked from the participant's treatment arm.
|
| Semi-Structured Interviews will be conducted at the end of the 12 week intervention. |
| The outcome will be reported at the end of the 12 week intervention. |
| BG001 | Telerehabilitation Physical Activity Behavioral (TPAB) Intervention - Care Partner | 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, including behavioral techniques, and patient-centered communication (e.g., motivational interviewing). The behavior-change techniques are designed to target and improve daily steps. |
| BG002 | Control Group - Patient | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
| BG003 | Control Group - Care Partner | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | m |
|
| Weight | Mean | Standard Deviation | kg |
|
| Education | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| OG001 | Telerehabilitation Physical Activity Behavioral (TPAB) Intervention - Care Partner | 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, including behavioral techniques, and patient-centered communication (e.g., motivational interviewing). The behavior-change techniques are designed to target and improve daily steps. |
| OG002 | Control Group - Patient | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
| OG003 | Control Group - Care Partner | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. |
|
|
| Primary | 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. | Participants in the control group did not receive the weekly intervention, so attendance was not tracked. | Posted | Number | % of sessions attended | The outcome will be reported at the end of the 12 week intervention. | sessions | sessions |
|
|
|
| Primary | 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. | Participants in the control group did not receive the intervention, and were therefore did not answer the acceptability questionnaire. | Posted | Mean | Standard Deviation | units on a scale | The outcome will be reported at the end of the 12 week intervention. |
|
|
|
| Primary | 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. | Posted | Number | adverse event(s) | The outcome will be reported at the end of the 12 week intervention. |
|
|
|
| Primary | 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. | One dyad from the intervention group did not complete the semi-structured interview, which is why 8 participants were analyzed instead of 10. Additionally, participants in the control group did not receive the intervention, so they did not complete semi-structured interviews regarding the feasibility of the intervention. Since this is qualitative data, the categories are general themes of what people said and the number reported is the number of participants that mentioned the theme. | Posted | Count of Participants | Participants | Semi-Structured Interviews will be conducted at the end of the 12 week intervention. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | steps | The outcome will be reported at the end of the 12 week intervention. |
|
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 1 |
| 5 |
| EG001 | Telerehabilitation Physical Activity Behavioral (TPAB) Intervention - Care Partner | 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, including behavioral techniques, and patient-centered communication (e.g., motivational interviewing). The behavior-change techniques are designed to target and improve daily steps. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Control Group | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Control Group - Care Partner | Individuals in the CTL group will receive usual care and no intervention over the 12 weeks. | 0 | 3 | 0 | 3 | 0 | 3 |
|
| Surgery for Collapsed Lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Participant went for a follow-up visit 1-month after hospitalization. Physician suggested surgery to close hole in lung. Surgery was successful and participant was discharged after 4 days. |
|
|
Not provided
Not provided
Not provided
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| sessions |
|
| Definition or Defining Physical Activity |
|
| Ideal Physical Activity Scenarios |
|
| Physical Activity Barriers |
|
| Physical Activity Facilitators |
|
| Program Outcomes |
|
| Dyad Bonding |
|
| Functional Outcomes |
|
| Changes in Exercise Habits |
|
| Fitness Tracker Usage |
|
| Inclusion of Care Partner in Intervention |
|
| Program Structure Feedback - Negative |
|
| Program Structure Feedback - Positive |
|
| Comparison of Study to other Programs |
|