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Improving Physical Activity With Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, Caregiver Burnout

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telerehabilitation physical activity behavioral (TPAB) intervention
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring physical activity, behavior change

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 50-85 years old (patient); 19+ years (caregiver)
  2. clinically diagnosed with amnestic MCI (patient only)
  3. a score of 18-24 on the Montreal Cognitive Assessment indicating possible MCI (patient only),
  4. not currently categorized as "Active" on the Rapid Assessment of Physical Activity, (patient only)
  5. on stable doses of medication at least for the previous 30 days at baseline (patient only)
  6. have a computer/wireless device with Internet access
  7. have a primary caregiver willing to participate in physical activity and assist the patient with participation in the study
  8. English-speaking

Exclusion Criteria:

  1. limitations due to disability, illness, or pain that may affect the patient's walking safety during the study
  2. unstable heart conditions (e.g., unstable angina, acute pericarditis)
  3. uncontrolled hypertension in the last six months
  4. known neurological diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Telerehabilitation physical activity behavioral (TPAB) intervention

    Control Group

    Arm Description

    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.

    Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.

    Outcomes

    Primary Outcome Measures

    TPAB intervention Participant Retention
    The number of participants that complete the 12 week intervention will be calculated to determine participant retention.
    TPAB Intervention Attendance
    The number of weekly sessions attended across the 12-week intervention will be totaled to determine the TPAB Intervention Attendance.
    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 total score ranges from 7-49 with higher scores indicating greater Interest/Enjoyment.
    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.
    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. Qualitative analysis will determine common themes in the responses.

    Secondary Outcome Measures

    Daily step count change
    daily step count will be measured with the activPAL physical activity monitor over a seven day period

    Full Information

    First Posted
    March 15, 2022
    Last Updated
    February 6, 2023
    Sponsor
    Creighton University
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05370118
    Brief Title
    Improving Physical Activity With Cognitive Impairment
    Official Title
    Improving Physical Activity With Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Creighton University
    Collaborators
    National Institutes of Health (NIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, Caregiver Burnout
    Keywords
    physical activity, behavior change

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Masking Description
    The outcomes assessors will be masked from the participant's treatment arm.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Telerehabilitation physical activity behavioral (TPAB) intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telerehabilitation physical activity behavioral (TPAB) intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    TPAB intervention Participant Retention
    Description
    The number of participants that complete the 12 week intervention will be calculated to determine participant retention.
    Time Frame
    The outcome will be reported at the end of the 12 week intervention.
    Title
    TPAB Intervention Attendance
    Description
    The number of weekly sessions attended across the 12-week intervention will be totaled to determine the TPAB Intervention Attendance.
    Time Frame
    The outcome will be reported at the end of the 12 week intervention.
    Title
    TPAB Intervention Acceptability
    Description
    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 total score ranges from 7-49 with higher scores indicating greater Interest/Enjoyment.
    Time Frame
    The outcome will be reported at the end of the 12 week intervention.
    Title
    TPAB Intervention Safety
    Description
    The safety of the TPAB Intervention will be assessed by tracking and comparing the number of adverse events in the intervention and control group.
    Time Frame
    The outcome will be reported at the end of the 12 week intervention.
    Title
    Feasibility of the TPAB Intervention (Semi-Structured Interviews)
    Description
    Semi-structured interview will be conducted on the patient and caregivers that participated in the TPAB Intervention. Qualitative analysis will determine common themes in the responses.
    Time Frame
    Semi-Structured Interviews will be conducted at the end of the 12 week intervention.
    Secondary Outcome Measure Information:
    Title
    Daily step count change
    Description
    daily step count will be measured with the activPAL physical activity monitor over a seven day period
    Time Frame
    Baseline and after the 12 week intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rashelle Hoffman, PT, DPT, PhD
    Phone
    402-280-5691
    Email
    rashellehoffman@creighton.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Individual Participant Data will be available upon request. Other data sharing is undecided at this time.

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